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VA Cancer Clinical Trials as a Strategy for Increasing Accrual of Racial and Ethnic Underrepresented Groups
Background
Cancer clinical trials (CCTs) are central to improving cancer care. However, generalizability of findings from CCTs is difficult due to the lack of diversity in most United States CCTs. Clinical trial accrual of underrepresented groups, is low throughout the United States and is approximately 4-5% in most CCTs. Reasons for low accrual in this population are multifactorial. Despite numerous factors related to accruing racial and ethnic underrepresented groups, many institutions have sought to address these barriers. We conducted a scoping review to identify evidence-based approaches to increase participation in cancer treatment clinical trials.
Methods
We reviewed the Salisbury VA Medical Center Oncology clinical trial database from October 2019 to June 2024. The participants in these clinical trials required consent. These clinical trials included treatment interventional as well as non-treatment interventional. Fifteen studies were included and over 260 Veterans participated.
Results
Key themes emerged that included a focus on patient education, cultural competency, and building capacity in the clinics to care for the Veteran population at three separate sites in the Salisbury VA system. The Black Veteran accrual rate of 29% was achieved. This accrual rate is representative of our VA catchment population of 33% for Black Veterans, and is five times the national average.
Conclusions
The research team’s success in enrolling Black Veterans in clinical trials is attributed to several factors. The demographic composition of Veterans served by the Salisbury, Charlotte, and Kernersville VA provided a diverse population that included a 33% Black group. The type of clinical trials focused on patients who were most impacted by the disease. The VA did afford less barriers to access to health care.
Background
Cancer clinical trials (CCTs) are central to improving cancer care. However, generalizability of findings from CCTs is difficult due to the lack of diversity in most United States CCTs. Clinical trial accrual of underrepresented groups, is low throughout the United States and is approximately 4-5% in most CCTs. Reasons for low accrual in this population are multifactorial. Despite numerous factors related to accruing racial and ethnic underrepresented groups, many institutions have sought to address these barriers. We conducted a scoping review to identify evidence-based approaches to increase participation in cancer treatment clinical trials.
Methods
We reviewed the Salisbury VA Medical Center Oncology clinical trial database from October 2019 to June 2024. The participants in these clinical trials required consent. These clinical trials included treatment interventional as well as non-treatment interventional. Fifteen studies were included and over 260 Veterans participated.
Results
Key themes emerged that included a focus on patient education, cultural competency, and building capacity in the clinics to care for the Veteran population at three separate sites in the Salisbury VA system. The Black Veteran accrual rate of 29% was achieved. This accrual rate is representative of our VA catchment population of 33% for Black Veterans, and is five times the national average.
Conclusions
The research team’s success in enrolling Black Veterans in clinical trials is attributed to several factors. The demographic composition of Veterans served by the Salisbury, Charlotte, and Kernersville VA provided a diverse population that included a 33% Black group. The type of clinical trials focused on patients who were most impacted by the disease. The VA did afford less barriers to access to health care.
Background
Cancer clinical trials (CCTs) are central to improving cancer care. However, generalizability of findings from CCTs is difficult due to the lack of diversity in most United States CCTs. Clinical trial accrual of underrepresented groups, is low throughout the United States and is approximately 4-5% in most CCTs. Reasons for low accrual in this population are multifactorial. Despite numerous factors related to accruing racial and ethnic underrepresented groups, many institutions have sought to address these barriers. We conducted a scoping review to identify evidence-based approaches to increase participation in cancer treatment clinical trials.
Methods
We reviewed the Salisbury VA Medical Center Oncology clinical trial database from October 2019 to June 2024. The participants in these clinical trials required consent. These clinical trials included treatment interventional as well as non-treatment interventional. Fifteen studies were included and over 260 Veterans participated.
Results
Key themes emerged that included a focus on patient education, cultural competency, and building capacity in the clinics to care for the Veteran population at three separate sites in the Salisbury VA system. The Black Veteran accrual rate of 29% was achieved. This accrual rate is representative of our VA catchment population of 33% for Black Veterans, and is five times the national average.
Conclusions
The research team’s success in enrolling Black Veterans in clinical trials is attributed to several factors. The demographic composition of Veterans served by the Salisbury, Charlotte, and Kernersville VA provided a diverse population that included a 33% Black group. The type of clinical trials focused on patients who were most impacted by the disease. The VA did afford less barriers to access to health care.
Improving Colorectal Cancer Screening via Mailed Fecal Immunochemical Testing in a Veterans Affairs Health System
Colorectal cancer (CRC) is among the most common cancers and causes of cancer-related deaths in the United States.1 Reflective of a nationwide trend, CRC screening rates at the Veterans Affairs Connecticut Healthcare System (VACHS) decreased during the COVID-19 pandemic.2-5 Contributing factors to this decrease included cancellations of elective colonoscopies during the initial phase of the pandemic and concurrent turnover of endoscopists. In 2021, the US Preventive Services Task Force lowered the recommended initial CRC screening age from 50 years to 45 years, further increasing the backlog of unscreened patients.6
Fecal immunochemical testing (FIT) is a noninvasive screening method in which antibodies are used to detect hemoglobin in the stool. The sensitivity and specificity of 1-time FIT are 79% to 80% and 94%, respectively, for the detection of CRC, with sensitivity improving with successive testing.7,8 Annual FIT is recognized as a tier 1 preferred screening method by the US Multi-Society Task Force on Colorectal Cancer.7,9 Programs that mail FIT kits to eligible patients outside of physician visits have been successfully implemented in health care systems.10,11
The VACHS designed and implemented a mailed FIT program using existing infrastructure and staffing.
Program Description
A team of local stakeholders comprised of VACHS leadership, primary care, nursing, and gastroenterology staff, as well as representatives from laboratory, informatics, mail services, and group practice management, was established to execute the project. The team met monthly to plan the project.
The team developed a dataset consisting of patients aged 45 to 75 years who were at average risk for CRC and due for CRC screening. Patients were defined as due for CRC screening if they had not had a colonoscopy in the previous 9 years or a FIT or fecal occult blood test in the previous 11 months. Average risk for CRC was defined by excluding patients with associated diagnosis codes for CRC, colectomy, inflammatory bowel disease, and anemia. The program also excluded patients with diagnosis codes associated with dementia, deferring discussions about cancer screening to their primary care practitioners (PCPs). Patients with invalid mailing addresses were also excluded, as well as those whose PCPs had indicated in the electronic health record that the patient received CRC screening outside the US Department of Veterans Affairs (VA) system.
Letter Templates
Two patient letter electronic health record templates were developed. The first was a primer letter, which was mailed to patients 2 to 3 weeks before the mailed FIT kit as an introduction to the program.12 The purpose of the primer letter was to give advance notice to patients that they could expect a FIT kit to arrive in the mail. The goal was to prepare patients to complete FIT when the kit arrived and prompt them to call the VA to opt out of the mailed FIT program if they were up to date with CRC screening or if they had a condition which made them at high risk for CRC.
The second FIT letter arrived with the FIT kit, introduced FIT and described the importance of CRC screening. The letter detailed instructions for completing FIT and automatically created a FIT order. It also included a list of common conditions that may exclude patients, with a recommendation for patients to contact their medical team if they felt they were not candidates for FIT.
Staff Education
A previous VACHS pilot project demonstrated the success of a mailed FIT program to increase FIT use. Implemented as part of the pilot program, staff education consisted of a session for clinicians about the role of FIT in CRC screening and an all-staff education session. An additional education session about CRC and FIT for all staff was repeated with the program launch.
Program Launch
The mailed FIT program was introduced during a VACHS primary care all-staff meeting. After the meeting, each patient aligned care team (PACT) received an encrypted email that included a list of the patients on their team who were candidates for the program, a patient-facing FIT instruction sheet, detailed instructions on how to send the FIT primer letter, and a FIT package consisting of the labeled FIT kit, FIT letter, and patient instruction sheet. A reminder letter was sent to each patient 3 weeks after the FIT package was mailed. The patient lists were populated into a shared, encrypted Microsoft Teams folder that was edited in real time by PACT teams and viewed by VACHS leadership to track progress.
Program Metrics
At program launch, the VACHS had 4642 patients due for CRC screening who were eligible for the mailed FIT program. On March 7, 2023, the data consisting of FIT tests ordered between December 2022 and May 2023—3 months before and after the launch of the program—were reviewed and categorized. In the 3 months before program launch, 1528 FIT were ordered and 714 were returned (46.7%). In the 3 months after the launch of the program, 4383 FIT were ordered and 1712 were returned (39.1%) (Figure). Test orders increased 287% from the preintervention to the postintervention period. The mean (SD) number of monthly FIT tests prelaunch was 509 (32.7), which increased to 1461 (331.6) postlaunch.
At the VACHS, 61.4% of patients aged 45 to 75 years were up to date with CRC screening before the program launch. In the 3 months after program launch, the rate increased to 63.8% among patients aged 45 to 75 years, the highest rate in our Veterans Integrated Services Network and exceeding the VA national average CRC screening rate, according to unpublished VA Monthly Management Report data.
In the 3 months following the program launch, 139 FIT kits tested positive for potential CRC. Of these, 79 (56.8%) patients had completed a diagnostic colonoscopy. PACT PCPs and nurses received reports on patients with positive FIT tests and those with no colonoscopy scheduled or completed and were asked to follow up.
Discussion
Through a proactive, population-based CRC screening program centered on mailed FIT kits outside of the traditional patient visit, the VACHS increased the use of FIT and rates of CRC screening. The numbers of FIT kits ordered and completed substantially increased in the 3 months after program launch.
Compared to mailed FIT programs described in the literature that rely on centralized processes in that a separate team operates the mailed FIT program for the entire organization, this program used existing PACT infrastructure and staff.10,11 This strategy allowed VACHS to design and implement the program in several months. Not needing to hire new staff or create a central team for the sole purpose of implementing the program allowed us to save on any organizational funding and efforts that would have accompanied the additional staff. The program described in this article may be more attainable for primary care practices or smaller health systems that do not have the capacity for the creation of a centralized process.
Limitations
Although the total number of FIT completions substantially increased during the program, the rate of FIT completion during the mailed FIT program was lower than the rate of completion prior to program launch. This decreased rate of FIT kit completion may be related to separation from a patient visit and potential loss of real-time education with a clinician. The program’s decentralized design increased the existing workload for primary care staff, and as a result, consideration must be given to local staffing levels. Additionally, the report of eligible patients depended on diagnosis codes and may have captured patients with higher-than-average risk of CRC, such as patients with prior history of adenomatous polyps, family history of CRC, or other medical or genetic conditions. We attempted to mitigate this by including a list of conditions that would exclude patients from FIT eligibility in the FIT letter and giving them the option to opt out.
Conclusions
CRC screening rates improved following implementation of a primary care team-centered quality improvement process to proactively identify patients appropriate for FIT and mail them FIT kits. This project highlights that population-health interventions around CRC screening via use of FIT can be successful within a primary care patient-centered medical home model, considering the increases in both CRC screening rates and increase in FIT tests ordered.
1. American Cancer Society. Key statistics for colorectal cancer. Revised January 29, 2024. Accessed June 11, 2024. https://www.cancer.org/cancer/types/colon-rectal-cancer/about/key-statistics.html
2. Chen RC, Haynes K, Du S, Barron J, Katz AJ. Association of cancer screening deficit in the United States with the COVID-19 pandemic. JAMA Oncol. 2021;7(6):878-884. doi:10.1001/jamaoncol.2021.0884
3. Mazidimoradi A, Tiznobaik A, Salehiniya H. Impact of the COVID-19 pandemic on colorectal cancer screening: a systematic review. J Gastrointest Cancer. 2022;53(3):730-744. doi:10.1007/s12029-021-00679-x
4. Adams MA, Kurlander JE, Gao Y, Yankey N, Saini SD. Impact of coronavirus disease 2019 on screening colonoscopy utilization in a large integrated health system. Gastroenterology. 2022;162(7):2098-2100.e2. doi:10.1053/j.gastro.2022.02.034
5. Sundaram S, Olson S, Sharma P, Rajendra S. A review of the impact of the COVID-19 pandemic on colorectal cancer screening: implications and solutions. Pathogens. 2021;10(11):558. doi:10.3390/pathogens10111508
6. US Preventive Services Task Force. Screening for colorectal cancer: US Preventive Services Task Force recommendation statement. JAMA. 2021;325(19):1965-1977. doi:10.1001/jama.2021.6238
7. Robertson DJ, Lee JK, Boland CR, et al. Recommendations on fecal immunochemical testing to screen for colorectal neoplasia: a consensus statement by the US Multi-Society Task Force on Colorectal Cancer. Gastrointest Endosc. 2017;85(1):2-21.e3. doi:10.1016/j.gie.2016.09.025
8. Lee JK, Liles EG, Bent S, Levin TR, Corley DA. Accuracy of fecal immunochemical tests for colorectal cancer: systematic review and meta-analysis. Ann Intern Med. 2014;160(3):171. doi:10.7326/M13-1484
9. Rex DK, Boland CR, Dominitz JA, et al. Colorectal cancer screening: recommendations for physicians and patients from the U.S. Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2017;153(1):307-323. doi:10.1053/j.gastro.2017.05.013
10. Deeds SA, Moore CB, Gunnink EJ, et al. Implementation of a mailed faecal immunochemical test programme for colorectal cancer screening among veterans. BMJ Open Qual. 2022;11(4):e001927. doi:10.1136/bmjoq-2022-001927
11. Selby K, Jensen CD, Levin TR, et al. Program components and results from an organized colorectal cancer screening program using annual fecal immunochemical testing. Clin Gastroenterol Hepatol. 2022;20(1):145-152. doi:10.1016/j.cgh.2020.09.042
12. Deeds S, Liu T, Schuttner L, et al. A postcard primer prior to mailed fecal immunochemical test among veterans: a randomized controlled trial. J Gen Intern Med. 2023:38(14):3235-3241. doi:10.1007/s11606-023-08248-7
Colorectal cancer (CRC) is among the most common cancers and causes of cancer-related deaths in the United States.1 Reflective of a nationwide trend, CRC screening rates at the Veterans Affairs Connecticut Healthcare System (VACHS) decreased during the COVID-19 pandemic.2-5 Contributing factors to this decrease included cancellations of elective colonoscopies during the initial phase of the pandemic and concurrent turnover of endoscopists. In 2021, the US Preventive Services Task Force lowered the recommended initial CRC screening age from 50 years to 45 years, further increasing the backlog of unscreened patients.6
Fecal immunochemical testing (FIT) is a noninvasive screening method in which antibodies are used to detect hemoglobin in the stool. The sensitivity and specificity of 1-time FIT are 79% to 80% and 94%, respectively, for the detection of CRC, with sensitivity improving with successive testing.7,8 Annual FIT is recognized as a tier 1 preferred screening method by the US Multi-Society Task Force on Colorectal Cancer.7,9 Programs that mail FIT kits to eligible patients outside of physician visits have been successfully implemented in health care systems.10,11
The VACHS designed and implemented a mailed FIT program using existing infrastructure and staffing.
Program Description
A team of local stakeholders comprised of VACHS leadership, primary care, nursing, and gastroenterology staff, as well as representatives from laboratory, informatics, mail services, and group practice management, was established to execute the project. The team met monthly to plan the project.
The team developed a dataset consisting of patients aged 45 to 75 years who were at average risk for CRC and due for CRC screening. Patients were defined as due for CRC screening if they had not had a colonoscopy in the previous 9 years or a FIT or fecal occult blood test in the previous 11 months. Average risk for CRC was defined by excluding patients with associated diagnosis codes for CRC, colectomy, inflammatory bowel disease, and anemia. The program also excluded patients with diagnosis codes associated with dementia, deferring discussions about cancer screening to their primary care practitioners (PCPs). Patients with invalid mailing addresses were also excluded, as well as those whose PCPs had indicated in the electronic health record that the patient received CRC screening outside the US Department of Veterans Affairs (VA) system.
Letter Templates
Two patient letter electronic health record templates were developed. The first was a primer letter, which was mailed to patients 2 to 3 weeks before the mailed FIT kit as an introduction to the program.12 The purpose of the primer letter was to give advance notice to patients that they could expect a FIT kit to arrive in the mail. The goal was to prepare patients to complete FIT when the kit arrived and prompt them to call the VA to opt out of the mailed FIT program if they were up to date with CRC screening or if they had a condition which made them at high risk for CRC.
The second FIT letter arrived with the FIT kit, introduced FIT and described the importance of CRC screening. The letter detailed instructions for completing FIT and automatically created a FIT order. It also included a list of common conditions that may exclude patients, with a recommendation for patients to contact their medical team if they felt they were not candidates for FIT.
Staff Education
A previous VACHS pilot project demonstrated the success of a mailed FIT program to increase FIT use. Implemented as part of the pilot program, staff education consisted of a session for clinicians about the role of FIT in CRC screening and an all-staff education session. An additional education session about CRC and FIT for all staff was repeated with the program launch.
Program Launch
The mailed FIT program was introduced during a VACHS primary care all-staff meeting. After the meeting, each patient aligned care team (PACT) received an encrypted email that included a list of the patients on their team who were candidates for the program, a patient-facing FIT instruction sheet, detailed instructions on how to send the FIT primer letter, and a FIT package consisting of the labeled FIT kit, FIT letter, and patient instruction sheet. A reminder letter was sent to each patient 3 weeks after the FIT package was mailed. The patient lists were populated into a shared, encrypted Microsoft Teams folder that was edited in real time by PACT teams and viewed by VACHS leadership to track progress.
Program Metrics
At program launch, the VACHS had 4642 patients due for CRC screening who were eligible for the mailed FIT program. On March 7, 2023, the data consisting of FIT tests ordered between December 2022 and May 2023—3 months before and after the launch of the program—were reviewed and categorized. In the 3 months before program launch, 1528 FIT were ordered and 714 were returned (46.7%). In the 3 months after the launch of the program, 4383 FIT were ordered and 1712 were returned (39.1%) (Figure). Test orders increased 287% from the preintervention to the postintervention period. The mean (SD) number of monthly FIT tests prelaunch was 509 (32.7), which increased to 1461 (331.6) postlaunch.
At the VACHS, 61.4% of patients aged 45 to 75 years were up to date with CRC screening before the program launch. In the 3 months after program launch, the rate increased to 63.8% among patients aged 45 to 75 years, the highest rate in our Veterans Integrated Services Network and exceeding the VA national average CRC screening rate, according to unpublished VA Monthly Management Report data.
In the 3 months following the program launch, 139 FIT kits tested positive for potential CRC. Of these, 79 (56.8%) patients had completed a diagnostic colonoscopy. PACT PCPs and nurses received reports on patients with positive FIT tests and those with no colonoscopy scheduled or completed and were asked to follow up.
Discussion
Through a proactive, population-based CRC screening program centered on mailed FIT kits outside of the traditional patient visit, the VACHS increased the use of FIT and rates of CRC screening. The numbers of FIT kits ordered and completed substantially increased in the 3 months after program launch.
Compared to mailed FIT programs described in the literature that rely on centralized processes in that a separate team operates the mailed FIT program for the entire organization, this program used existing PACT infrastructure and staff.10,11 This strategy allowed VACHS to design and implement the program in several months. Not needing to hire new staff or create a central team for the sole purpose of implementing the program allowed us to save on any organizational funding and efforts that would have accompanied the additional staff. The program described in this article may be more attainable for primary care practices or smaller health systems that do not have the capacity for the creation of a centralized process.
Limitations
Although the total number of FIT completions substantially increased during the program, the rate of FIT completion during the mailed FIT program was lower than the rate of completion prior to program launch. This decreased rate of FIT kit completion may be related to separation from a patient visit and potential loss of real-time education with a clinician. The program’s decentralized design increased the existing workload for primary care staff, and as a result, consideration must be given to local staffing levels. Additionally, the report of eligible patients depended on diagnosis codes and may have captured patients with higher-than-average risk of CRC, such as patients with prior history of adenomatous polyps, family history of CRC, or other medical or genetic conditions. We attempted to mitigate this by including a list of conditions that would exclude patients from FIT eligibility in the FIT letter and giving them the option to opt out.
Conclusions
CRC screening rates improved following implementation of a primary care team-centered quality improvement process to proactively identify patients appropriate for FIT and mail them FIT kits. This project highlights that population-health interventions around CRC screening via use of FIT can be successful within a primary care patient-centered medical home model, considering the increases in both CRC screening rates and increase in FIT tests ordered.
Colorectal cancer (CRC) is among the most common cancers and causes of cancer-related deaths in the United States.1 Reflective of a nationwide trend, CRC screening rates at the Veterans Affairs Connecticut Healthcare System (VACHS) decreased during the COVID-19 pandemic.2-5 Contributing factors to this decrease included cancellations of elective colonoscopies during the initial phase of the pandemic and concurrent turnover of endoscopists. In 2021, the US Preventive Services Task Force lowered the recommended initial CRC screening age from 50 years to 45 years, further increasing the backlog of unscreened patients.6
Fecal immunochemical testing (FIT) is a noninvasive screening method in which antibodies are used to detect hemoglobin in the stool. The sensitivity and specificity of 1-time FIT are 79% to 80% and 94%, respectively, for the detection of CRC, with sensitivity improving with successive testing.7,8 Annual FIT is recognized as a tier 1 preferred screening method by the US Multi-Society Task Force on Colorectal Cancer.7,9 Programs that mail FIT kits to eligible patients outside of physician visits have been successfully implemented in health care systems.10,11
The VACHS designed and implemented a mailed FIT program using existing infrastructure and staffing.
Program Description
A team of local stakeholders comprised of VACHS leadership, primary care, nursing, and gastroenterology staff, as well as representatives from laboratory, informatics, mail services, and group practice management, was established to execute the project. The team met monthly to plan the project.
The team developed a dataset consisting of patients aged 45 to 75 years who were at average risk for CRC and due for CRC screening. Patients were defined as due for CRC screening if they had not had a colonoscopy in the previous 9 years or a FIT or fecal occult blood test in the previous 11 months. Average risk for CRC was defined by excluding patients with associated diagnosis codes for CRC, colectomy, inflammatory bowel disease, and anemia. The program also excluded patients with diagnosis codes associated with dementia, deferring discussions about cancer screening to their primary care practitioners (PCPs). Patients with invalid mailing addresses were also excluded, as well as those whose PCPs had indicated in the electronic health record that the patient received CRC screening outside the US Department of Veterans Affairs (VA) system.
Letter Templates
Two patient letter electronic health record templates were developed. The first was a primer letter, which was mailed to patients 2 to 3 weeks before the mailed FIT kit as an introduction to the program.12 The purpose of the primer letter was to give advance notice to patients that they could expect a FIT kit to arrive in the mail. The goal was to prepare patients to complete FIT when the kit arrived and prompt them to call the VA to opt out of the mailed FIT program if they were up to date with CRC screening or if they had a condition which made them at high risk for CRC.
The second FIT letter arrived with the FIT kit, introduced FIT and described the importance of CRC screening. The letter detailed instructions for completing FIT and automatically created a FIT order. It also included a list of common conditions that may exclude patients, with a recommendation for patients to contact their medical team if they felt they were not candidates for FIT.
Staff Education
A previous VACHS pilot project demonstrated the success of a mailed FIT program to increase FIT use. Implemented as part of the pilot program, staff education consisted of a session for clinicians about the role of FIT in CRC screening and an all-staff education session. An additional education session about CRC and FIT for all staff was repeated with the program launch.
Program Launch
The mailed FIT program was introduced during a VACHS primary care all-staff meeting. After the meeting, each patient aligned care team (PACT) received an encrypted email that included a list of the patients on their team who were candidates for the program, a patient-facing FIT instruction sheet, detailed instructions on how to send the FIT primer letter, and a FIT package consisting of the labeled FIT kit, FIT letter, and patient instruction sheet. A reminder letter was sent to each patient 3 weeks after the FIT package was mailed. The patient lists were populated into a shared, encrypted Microsoft Teams folder that was edited in real time by PACT teams and viewed by VACHS leadership to track progress.
Program Metrics
At program launch, the VACHS had 4642 patients due for CRC screening who were eligible for the mailed FIT program. On March 7, 2023, the data consisting of FIT tests ordered between December 2022 and May 2023—3 months before and after the launch of the program—were reviewed and categorized. In the 3 months before program launch, 1528 FIT were ordered and 714 were returned (46.7%). In the 3 months after the launch of the program, 4383 FIT were ordered and 1712 were returned (39.1%) (Figure). Test orders increased 287% from the preintervention to the postintervention period. The mean (SD) number of monthly FIT tests prelaunch was 509 (32.7), which increased to 1461 (331.6) postlaunch.
At the VACHS, 61.4% of patients aged 45 to 75 years were up to date with CRC screening before the program launch. In the 3 months after program launch, the rate increased to 63.8% among patients aged 45 to 75 years, the highest rate in our Veterans Integrated Services Network and exceeding the VA national average CRC screening rate, according to unpublished VA Monthly Management Report data.
In the 3 months following the program launch, 139 FIT kits tested positive for potential CRC. Of these, 79 (56.8%) patients had completed a diagnostic colonoscopy. PACT PCPs and nurses received reports on patients with positive FIT tests and those with no colonoscopy scheduled or completed and were asked to follow up.
Discussion
Through a proactive, population-based CRC screening program centered on mailed FIT kits outside of the traditional patient visit, the VACHS increased the use of FIT and rates of CRC screening. The numbers of FIT kits ordered and completed substantially increased in the 3 months after program launch.
Compared to mailed FIT programs described in the literature that rely on centralized processes in that a separate team operates the mailed FIT program for the entire organization, this program used existing PACT infrastructure and staff.10,11 This strategy allowed VACHS to design and implement the program in several months. Not needing to hire new staff or create a central team for the sole purpose of implementing the program allowed us to save on any organizational funding and efforts that would have accompanied the additional staff. The program described in this article may be more attainable for primary care practices or smaller health systems that do not have the capacity for the creation of a centralized process.
Limitations
Although the total number of FIT completions substantially increased during the program, the rate of FIT completion during the mailed FIT program was lower than the rate of completion prior to program launch. This decreased rate of FIT kit completion may be related to separation from a patient visit and potential loss of real-time education with a clinician. The program’s decentralized design increased the existing workload for primary care staff, and as a result, consideration must be given to local staffing levels. Additionally, the report of eligible patients depended on diagnosis codes and may have captured patients with higher-than-average risk of CRC, such as patients with prior history of adenomatous polyps, family history of CRC, or other medical or genetic conditions. We attempted to mitigate this by including a list of conditions that would exclude patients from FIT eligibility in the FIT letter and giving them the option to opt out.
Conclusions
CRC screening rates improved following implementation of a primary care team-centered quality improvement process to proactively identify patients appropriate for FIT and mail them FIT kits. This project highlights that population-health interventions around CRC screening via use of FIT can be successful within a primary care patient-centered medical home model, considering the increases in both CRC screening rates and increase in FIT tests ordered.
1. American Cancer Society. Key statistics for colorectal cancer. Revised January 29, 2024. Accessed June 11, 2024. https://www.cancer.org/cancer/types/colon-rectal-cancer/about/key-statistics.html
2. Chen RC, Haynes K, Du S, Barron J, Katz AJ. Association of cancer screening deficit in the United States with the COVID-19 pandemic. JAMA Oncol. 2021;7(6):878-884. doi:10.1001/jamaoncol.2021.0884
3. Mazidimoradi A, Tiznobaik A, Salehiniya H. Impact of the COVID-19 pandemic on colorectal cancer screening: a systematic review. J Gastrointest Cancer. 2022;53(3):730-744. doi:10.1007/s12029-021-00679-x
4. Adams MA, Kurlander JE, Gao Y, Yankey N, Saini SD. Impact of coronavirus disease 2019 on screening colonoscopy utilization in a large integrated health system. Gastroenterology. 2022;162(7):2098-2100.e2. doi:10.1053/j.gastro.2022.02.034
5. Sundaram S, Olson S, Sharma P, Rajendra S. A review of the impact of the COVID-19 pandemic on colorectal cancer screening: implications and solutions. Pathogens. 2021;10(11):558. doi:10.3390/pathogens10111508
6. US Preventive Services Task Force. Screening for colorectal cancer: US Preventive Services Task Force recommendation statement. JAMA. 2021;325(19):1965-1977. doi:10.1001/jama.2021.6238
7. Robertson DJ, Lee JK, Boland CR, et al. Recommendations on fecal immunochemical testing to screen for colorectal neoplasia: a consensus statement by the US Multi-Society Task Force on Colorectal Cancer. Gastrointest Endosc. 2017;85(1):2-21.e3. doi:10.1016/j.gie.2016.09.025
8. Lee JK, Liles EG, Bent S, Levin TR, Corley DA. Accuracy of fecal immunochemical tests for colorectal cancer: systematic review and meta-analysis. Ann Intern Med. 2014;160(3):171. doi:10.7326/M13-1484
9. Rex DK, Boland CR, Dominitz JA, et al. Colorectal cancer screening: recommendations for physicians and patients from the U.S. Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2017;153(1):307-323. doi:10.1053/j.gastro.2017.05.013
10. Deeds SA, Moore CB, Gunnink EJ, et al. Implementation of a mailed faecal immunochemical test programme for colorectal cancer screening among veterans. BMJ Open Qual. 2022;11(4):e001927. doi:10.1136/bmjoq-2022-001927
11. Selby K, Jensen CD, Levin TR, et al. Program components and results from an organized colorectal cancer screening program using annual fecal immunochemical testing. Clin Gastroenterol Hepatol. 2022;20(1):145-152. doi:10.1016/j.cgh.2020.09.042
12. Deeds S, Liu T, Schuttner L, et al. A postcard primer prior to mailed fecal immunochemical test among veterans: a randomized controlled trial. J Gen Intern Med. 2023:38(14):3235-3241. doi:10.1007/s11606-023-08248-7
1. American Cancer Society. Key statistics for colorectal cancer. Revised January 29, 2024. Accessed June 11, 2024. https://www.cancer.org/cancer/types/colon-rectal-cancer/about/key-statistics.html
2. Chen RC, Haynes K, Du S, Barron J, Katz AJ. Association of cancer screening deficit in the United States with the COVID-19 pandemic. JAMA Oncol. 2021;7(6):878-884. doi:10.1001/jamaoncol.2021.0884
3. Mazidimoradi A, Tiznobaik A, Salehiniya H. Impact of the COVID-19 pandemic on colorectal cancer screening: a systematic review. J Gastrointest Cancer. 2022;53(3):730-744. doi:10.1007/s12029-021-00679-x
4. Adams MA, Kurlander JE, Gao Y, Yankey N, Saini SD. Impact of coronavirus disease 2019 on screening colonoscopy utilization in a large integrated health system. Gastroenterology. 2022;162(7):2098-2100.e2. doi:10.1053/j.gastro.2022.02.034
5. Sundaram S, Olson S, Sharma P, Rajendra S. A review of the impact of the COVID-19 pandemic on colorectal cancer screening: implications and solutions. Pathogens. 2021;10(11):558. doi:10.3390/pathogens10111508
6. US Preventive Services Task Force. Screening for colorectal cancer: US Preventive Services Task Force recommendation statement. JAMA. 2021;325(19):1965-1977. doi:10.1001/jama.2021.6238
7. Robertson DJ, Lee JK, Boland CR, et al. Recommendations on fecal immunochemical testing to screen for colorectal neoplasia: a consensus statement by the US Multi-Society Task Force on Colorectal Cancer. Gastrointest Endosc. 2017;85(1):2-21.e3. doi:10.1016/j.gie.2016.09.025
8. Lee JK, Liles EG, Bent S, Levin TR, Corley DA. Accuracy of fecal immunochemical tests for colorectal cancer: systematic review and meta-analysis. Ann Intern Med. 2014;160(3):171. doi:10.7326/M13-1484
9. Rex DK, Boland CR, Dominitz JA, et al. Colorectal cancer screening: recommendations for physicians and patients from the U.S. Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2017;153(1):307-323. doi:10.1053/j.gastro.2017.05.013
10. Deeds SA, Moore CB, Gunnink EJ, et al. Implementation of a mailed faecal immunochemical test programme for colorectal cancer screening among veterans. BMJ Open Qual. 2022;11(4):e001927. doi:10.1136/bmjoq-2022-001927
11. Selby K, Jensen CD, Levin TR, et al. Program components and results from an organized colorectal cancer screening program using annual fecal immunochemical testing. Clin Gastroenterol Hepatol. 2022;20(1):145-152. doi:10.1016/j.cgh.2020.09.042
12. Deeds S, Liu T, Schuttner L, et al. A postcard primer prior to mailed fecal immunochemical test among veterans: a randomized controlled trial. J Gen Intern Med. 2023:38(14):3235-3241. doi:10.1007/s11606-023-08248-7
A Group Approach to Clinical Research Mentorship at a Veterans Affairs Medical Center
A Group Approach to Clinical Research Mentorship at a Veterans Affairs Medical Center
Supporting meaningful research that has a positive impact on the health and quality of life of veterans is a priority of the US Department of Veterans Affairs Office of Research and Development.1 For nearly a century, VA researchers have been conducting high quality studies. To continue this trajectory, it is imperative to attract, train, and retain exceptional investigators while nurturing their development throughout their careers.2
Mentorship is defined as guidance provided by an experienced and trusted party to another (usually junior) individual with the intent of helping the person succeed. It benefits the mentee, mentor, and their institutions.3 Mentorship is crucial for personal and professional development as well as productivity, which may help reduce clinician burnout.4-7 Conversely, a lack of mentorship could have negative effects on work satisfaction and stagnate career progression.8
Mentorship is vital for developing and advancing a VA investigator’s research agenda. Funding, grant writing, and research design were among the most discussed topics in a large comprehensive mentorship program for academic faculty.9 However, there are several known barriers to effective research mentorship; among them include a lack of resources, time constraints, and competing clinical priorities.10,11
Finding time for effective one-on-one research mentoring is difficult within the time constraints of clinical duties; a group mentorship model may help overcome this barrier. Group mentorship can aid in personal and professional development because no single mentor can effectively meet every mentoring need of an individual.12 Group mentorship also allows for the exchange of ideas among individuals with different backgrounds and the ability to utilize the strengths of each member of the group. For example, a member may have methodological expertise, while another may be skilled in grantsmanship. A team of mentors may be more beneficial for both the mentors (eg, establish a more manageable workload) and the mentee (eg, gains a broader perspective of expertise) when compared to having a single mentor.3
Peer mentorship within the group setting may also yield additional benefits. For example, having a supportive peer group may help reduce stress levels and burnout, while also improving overall well-being.3,13 Formal mentorship programs do not frequently discuss concerns such as work-life balance, so including peers as mentors may help fill this void.9 Peer mentorship has also been found to be beneficial in providing mentees with pooled resources and shared learning.12,13 This article describes the components, benefits, impacts, and challenges of a group research mentorship program for VA clinicians interested in conducting VArelevant research.
Program Description
The VA Clinical Research Mentorship Program was initiated at the VA Ann Arbor Healthcare System (VAAAHS) in October 2015 by the Chief of Medicine to assist VA clinician investigators with developing and submitting VA clinical science and health services research grant applications. The program offers group and one-on-one consultation services through the expertise of 2 experienced investigators/faculty mentors who also serve as program directors, each of whom devote about 3 to 5 hours per month to activities associated with the mentorship program (eg, attending the meeting, reviewing materials sent by mentees, and one-on-one discussions with mentees).
The program also fostered peer-led mentorship. This encourages all attendees to provide feedback during group sessions and communication by mentees outside the group sessions. An experienced project manager serves as program coordinator and contributes about 4 hours per month for activities such as attending, scheduling, and sending reminders for each meeting, distributing handouts, reviewing materials, and answering mentee’s questions via email. A statistician and additional research staff (ie, an epidemiologist and research assistant) do not attend the recurring meetings, but are available for offline consultation as needed. The program runs on a 12-month cycle with regular meetings occurring twice monthly during the 9-month academic period. Resources to support the program, primarily program director(s) and project coordinator effort, are provided by the Chief of Medicine and through the VAAAHS affiliated VA Health Systems Research (formerly Health Services Research & Development) Center of Innovation.
Invitations for new mentees are sent annually. Mentees expressing interest in the program outside of its annual recruitment period are evaluated for inclusion on a rolling basis. Recruitment begins with the program coordinator sending email notifications to all VAAAHS Medicine Service faculty, section chiefs, and division chiefs at the VAAAHS academic affiliate. Recipients are encouraged to distribute the announcement to eligible applicants and refer them to the application materials for entry consideration into the program. The application consists of the applicant’s curriculum vitae and a 1-page summary that includes a description of their research area of interest, how it is relevant to the VA, in addition to an idea for a research study, its potential significance, and proposed methodology. Applicant materials are reviewed by the program coordinator and program directors. The applicants are evaluated using a simple scoring approach that focuses on the applicant’s research area and agenda, past research training, past research productivity, potential for obtaining VA funding, and whether they have sufficient research time.
Program eligibility initially required being a physician with ≥ 1/8 VA appointment from the Medicine Service. However, clinicians with clinical appointments from other VA services are also accepted for participation as needed. Applicants must have previous research experience and have a career goal to obtain external funding for conducting and publishing original research. Those who have previously served as a principal investigator on a funded VA grant proposal are not eligible as new applicants but can remain in the program as peer mentors. The number of annual applicants varies and ranges from 1 to 11; on average, about 90% of applicants receive invitations to join the program.
Sessions
The program holds recurring meetings twice monthly for 1 hour during the 9-month academic year. However, program directors are available year-round, and mentees are encouraged to communicate questions or concerns via email during nonacademic months. Prior to the COVID-19 pandemic, all meetings were held in-person. However, the group pivoted to virtual meetings and continues to utilize this format. The dedicated program coordinator is responsible for coordinating meetings and distributing meeting materials.
Each session is informal, flexible, and supportive. Attendance is not enforced, and mentees are allowed to join meetings as their schedules permit; however, program directors and program coordinator attend each meeting. In advance of each session, the program coordinator sends out a call for agenda items to all active members invited to discuss any research related items. Each mentee presents their ideas to lead the discussion for their portion of the meeting with no defined format required.
A variety of topics are covered including, but not limited to: (1) grant-specific concerns (eg, questions related to specific aim pages, grantsmanship, postsubmission comments from reviewers, or postaward logistics); (2) research procedures (eg, questions related to methodological practices or institutional review board concerns); (3) manuscript or presentation preparation; and (4) careerrelated issues. The program coordinator distributes handouts prior to meetings and mentees may record their presentations. These handouts may include, but are not limited to, specific aims pages, analytical plans, grant solicitations, and PowerPoint presentations. If a resource that can benefit the entire group is mentioned during the meeting, the program coordinator is responsible for distribution.
The program follows a group facilitated discussion format. Program directors facilitate each meeting, but input is encouraged from all attendees. This model allows for mentees to learn from the faculty mentors as well as peer mentees in a simultaneous and efficient fashion. Group discussions foster collective problem solving, peer support, and resource sharing that would not be possible through individualized mentorship. Participants have access to varied expertise during each session which reduces the need to seek specialized help elsewhere. Participants are also encouraged to contact the program directors or research staff for consultation as needed. Some one-on-one consultations have transitioned to a more sustained and ongoing mentorship relationship between a program director and mentee, but most are often brief email exchanges or a single meeting.
Participants
Since its inception in 2015, 35 clinicians have enrolled in the program. The mentees are equally distributed by sex and practice in a variety of disciplines including gastroenterology, hematology/oncology, cardiology, and general medicine (Table 1). Mentees have submitted 33 grant proposals addressing a variety of health care issues to a diverse group of federal and nonfederal funding agencies (Table 2). As of May 15, 2024, 19 (58%) of the submitted applications have been funded.
Many factors contribute to a successfully funded grant application, and several mentees report that participating in the mentorship program was helpful. For example, a mentee became the first lead investigator for a VA Cooperative Studies Program funded at VAAAHS. The VA Cooperative Studies Program, a division of the Office of Research and Development, plans and conducts large multicenter clinical trials and epidemiological studies within the VA via a vast network of clinician investigators, statisticians, and other key research experts.14
Several program mentees have also received VA Clinical Science Research and Development Career Development Awards. The VA Career Development program supports investigators during their early research careers with a goal of retaining talented researchers committed to improving the health and care of veterans.15
Survey Responses
Mentee productivity and updates are tracked through direct mentee input, as requested by the program coordinator. Since 2022, participants could complete an end-of-year survey based on an assessment tool used in a VAAAHS nonresearch mentorship program.16 The survey, distributed to mentees and program directors, requests feedback on logistics (eg, if the meeting was a good use of time and barriers to attendance); perceptions of effectiveness (eg, ability to discuss agenda items, helpfulness with setting and reaching research goals, and quality of mentors’ feedback); and the impact of the mentoring program on work satisfaction and clinician burnout. Respondents are also encouraged to leave open-ended qualitative feedback.
To date the survey has elicited 19 responses. Seventeen (89%) indicated that they agree or strongly agree the meetings were an effective use of their time and 11 (58%) indicated that they were able to discuss all or most of the items they wanted to during the meeting. Sixteen respondents (84%) agreed the program helped them set and achieve their research goals and 14 respondents (74%) agreed the feedback they received during the meeting was specific, actionable, and focused on how to improve their research agenda. Seventeen respondents (89%) agreed the program increased their work satisfaction, while 13 respondents (68%) felt the program reduced levels of clinician burnout.
As attendance was not mandatory, the survey asked participants how often they attended meetings during the past year. Responses were mixed: 4 (21%) respondents attended regularly (12 to 16 times per year) and 8 (42%) attended most sessions (8 to 11 times per year). Noted barriers to attendance included conflicts with patient care activities and conflicts with other high priority meetings.
Mentees also provided qualitive feedback regarding the program. They highlighted the supportive environment, valuable expertise of the mentors, and usefulness of obtaining tailored feedback from the group. “This group is an amazing resource to anyone developing a research career,” a mentee noted, adding that the program directors “fostered an incredibly supportive group where research ideas and methodology can be explored in a nonthreatening and creative environment.”
Conclusions
This mentorship program aims to help aspiring VA clinician investigators develop and submit competitive research grant applications. The addition of the program to the existing robust research environments at VAAAHS and its academic affiliate appears to have contributed to this success, with 58% of applications submitted by program mentees receiving funding.
In addition to funding success, we also found that most participants have a favorable impression of the program. Of the participants who responded to the program evaluation survey, nearly all indicated the program was an effective use of their time. The program also appeared to increase work satisfaction and reduce levels of clinician burnout. Barriers to attendance were also noted, with the most frequent being scheduling conflicts.
This program’s format includes facilitated group discussion as well as peer mentorship. This collaborative structure allows for an efficient and rich learning experience. Feedback from multiple perspectives encourages natural networking and relationship building. Incorporating the collective wisdom of the faculty mentors and peer mentees is beneficial; it not only empowers the mentees but also enriches the experience for the mentors. This program can serve as a model for other VA facilities—or non-VA academic medical centers—to enhance their research programs.
- US Department of Veterans Affairs, Office of Research and Development. Strategic priorities for VA research. Published March 10, 2021. Accessed September 17, 2024. https://www.research.va.gov/about/strategic_priorities.cfm
- . US Department of Veterans Affairs, Office of Research and Development. About the Office of Research & Development. Published November 11, 2023. Accessed September 17, 2024. https://www.research.va.gov/about/default.cfm
- Chopra V, Vaughn V, Saint S. The Mentoring Guide: Helping Mentors and Mentees Succeed. Michigan Publishing Services; 2019.
- Gilster SD, Accorinti KL. Mentoring program yields staff satisfaction. Mentoring through the exchange of information across all organizational levels can help administrators retain valuable staff. Provider. 1999;25(10):99-100.
- Ramanan RA, Phillips RS, Davis RB, Silen W, Reede JY. Mentoring in medicine: keys to satisfaction. Am J Med. 2002;112(4):336-341. doi:10.1016/s0002-9343(02)01032-x
- Sambunjak D, Straus SE, Marusi' A. Mentoring in academic medicine: a systematic review. JAMA. 2006;296(9):1103-1115. doi:10.1001/jama.296.9.1103
- Sambunjak D, Straus SE, Marusi' A. A systematic review of qualitative research on the meaning and characteristics of mentoring in academic medicine. J Gen Intern Med. 2010;25(1):72-78. doi:10.1007/s11606-009-1165-8
- Jackson VA, Palepu A, Szalacha L, Caswell C, Carr PL, Inui T. “Having the right chemistry”: a qualitative study of mentoring in academic medicine. Acad Med. 2003;78(3):328-334. doi:10.1097/00001888-200303000-00020
- Feldman MD, Arean PA, Marshall SJ, Lovett M, O’Sullivan P. Does mentoring matter: results from a survey of faculty mentees at a large health sciences university. Med Educ Online. 2010;15:10.3402/meo.v15i0.5063. doi:10.3402/meo.v15i0.5063
- Leary JC, Schainker EG, Leyenaar JK. The unwritten rules of mentorship: facilitators of and barriers to effective mentorship in pediatric hospital medicine. Hosp Pediatr. 2016;6(4):219-225. doi:10.1542/hpeds.2015-0108
- Rustgi AK, Hecht GA. Mentorship in academic medicine. Gastroenterology. 2011;141(3):789-792. doi:10.1053/j.gastro.2011.07.024
- DeCastro R, Sambuco D, Ubel PA, Stewart A, Jagsi R. Mentor networks in academic medicine: moving beyond a dyadic conception of mentoring for junior faculty researchers. Acad Med. 2013;88(4):488-496. doi:10.1097/ACM.0b013e318285d302
- McDaugall M, Beattie RS. Peer mentoring at work: the nature and outcomes of non-hierarchical developmental relationships. Management Learning. 2016;28(4):423-437. doi:10.1177/1350507697284003
- US Department of Veterans Affairs, Office of Rsearch and Development. VA Cooperative Studies Program (CSP). Updated July 2019. Accessed September 17, 2024. https://www.vacsp.research.va.gov
- US Department of Veterans Affairs, Office of Research and Development. Career development program for biomedical laboratory and clinical science R&D services. Published April 17, 2023. Accessed September 17, 2024. https://www.research.va.gov/services/shared_docs/career_dev.cfm
- Houchens N, Kuhn L, Ratz D, Su G, Saint S. Committed to success: a structured mentoring program for clinically-oriented physicians. Mayo Clin Pro Innov Qual Outcomes. 2024;8(4):356-363. doi:10.1016/j.mayocpiqo.2024.05.002
Supporting meaningful research that has a positive impact on the health and quality of life of veterans is a priority of the US Department of Veterans Affairs Office of Research and Development.1 For nearly a century, VA researchers have been conducting high quality studies. To continue this trajectory, it is imperative to attract, train, and retain exceptional investigators while nurturing their development throughout their careers.2
Mentorship is defined as guidance provided by an experienced and trusted party to another (usually junior) individual with the intent of helping the person succeed. It benefits the mentee, mentor, and their institutions.3 Mentorship is crucial for personal and professional development as well as productivity, which may help reduce clinician burnout.4-7 Conversely, a lack of mentorship could have negative effects on work satisfaction and stagnate career progression.8
Mentorship is vital for developing and advancing a VA investigator’s research agenda. Funding, grant writing, and research design were among the most discussed topics in a large comprehensive mentorship program for academic faculty.9 However, there are several known barriers to effective research mentorship; among them include a lack of resources, time constraints, and competing clinical priorities.10,11
Finding time for effective one-on-one research mentoring is difficult within the time constraints of clinical duties; a group mentorship model may help overcome this barrier. Group mentorship can aid in personal and professional development because no single mentor can effectively meet every mentoring need of an individual.12 Group mentorship also allows for the exchange of ideas among individuals with different backgrounds and the ability to utilize the strengths of each member of the group. For example, a member may have methodological expertise, while another may be skilled in grantsmanship. A team of mentors may be more beneficial for both the mentors (eg, establish a more manageable workload) and the mentee (eg, gains a broader perspective of expertise) when compared to having a single mentor.3
Peer mentorship within the group setting may also yield additional benefits. For example, having a supportive peer group may help reduce stress levels and burnout, while also improving overall well-being.3,13 Formal mentorship programs do not frequently discuss concerns such as work-life balance, so including peers as mentors may help fill this void.9 Peer mentorship has also been found to be beneficial in providing mentees with pooled resources and shared learning.12,13 This article describes the components, benefits, impacts, and challenges of a group research mentorship program for VA clinicians interested in conducting VArelevant research.
Program Description
The VA Clinical Research Mentorship Program was initiated at the VA Ann Arbor Healthcare System (VAAAHS) in October 2015 by the Chief of Medicine to assist VA clinician investigators with developing and submitting VA clinical science and health services research grant applications. The program offers group and one-on-one consultation services through the expertise of 2 experienced investigators/faculty mentors who also serve as program directors, each of whom devote about 3 to 5 hours per month to activities associated with the mentorship program (eg, attending the meeting, reviewing materials sent by mentees, and one-on-one discussions with mentees).
The program also fostered peer-led mentorship. This encourages all attendees to provide feedback during group sessions and communication by mentees outside the group sessions. An experienced project manager serves as program coordinator and contributes about 4 hours per month for activities such as attending, scheduling, and sending reminders for each meeting, distributing handouts, reviewing materials, and answering mentee’s questions via email. A statistician and additional research staff (ie, an epidemiologist and research assistant) do not attend the recurring meetings, but are available for offline consultation as needed. The program runs on a 12-month cycle with regular meetings occurring twice monthly during the 9-month academic period. Resources to support the program, primarily program director(s) and project coordinator effort, are provided by the Chief of Medicine and through the VAAAHS affiliated VA Health Systems Research (formerly Health Services Research & Development) Center of Innovation.
Invitations for new mentees are sent annually. Mentees expressing interest in the program outside of its annual recruitment period are evaluated for inclusion on a rolling basis. Recruitment begins with the program coordinator sending email notifications to all VAAAHS Medicine Service faculty, section chiefs, and division chiefs at the VAAAHS academic affiliate. Recipients are encouraged to distribute the announcement to eligible applicants and refer them to the application materials for entry consideration into the program. The application consists of the applicant’s curriculum vitae and a 1-page summary that includes a description of their research area of interest, how it is relevant to the VA, in addition to an idea for a research study, its potential significance, and proposed methodology. Applicant materials are reviewed by the program coordinator and program directors. The applicants are evaluated using a simple scoring approach that focuses on the applicant’s research area and agenda, past research training, past research productivity, potential for obtaining VA funding, and whether they have sufficient research time.
Program eligibility initially required being a physician with ≥ 1/8 VA appointment from the Medicine Service. However, clinicians with clinical appointments from other VA services are also accepted for participation as needed. Applicants must have previous research experience and have a career goal to obtain external funding for conducting and publishing original research. Those who have previously served as a principal investigator on a funded VA grant proposal are not eligible as new applicants but can remain in the program as peer mentors. The number of annual applicants varies and ranges from 1 to 11; on average, about 90% of applicants receive invitations to join the program.
Sessions
The program holds recurring meetings twice monthly for 1 hour during the 9-month academic year. However, program directors are available year-round, and mentees are encouraged to communicate questions or concerns via email during nonacademic months. Prior to the COVID-19 pandemic, all meetings were held in-person. However, the group pivoted to virtual meetings and continues to utilize this format. The dedicated program coordinator is responsible for coordinating meetings and distributing meeting materials.
Each session is informal, flexible, and supportive. Attendance is not enforced, and mentees are allowed to join meetings as their schedules permit; however, program directors and program coordinator attend each meeting. In advance of each session, the program coordinator sends out a call for agenda items to all active members invited to discuss any research related items. Each mentee presents their ideas to lead the discussion for their portion of the meeting with no defined format required.
A variety of topics are covered including, but not limited to: (1) grant-specific concerns (eg, questions related to specific aim pages, grantsmanship, postsubmission comments from reviewers, or postaward logistics); (2) research procedures (eg, questions related to methodological practices or institutional review board concerns); (3) manuscript or presentation preparation; and (4) careerrelated issues. The program coordinator distributes handouts prior to meetings and mentees may record their presentations. These handouts may include, but are not limited to, specific aims pages, analytical plans, grant solicitations, and PowerPoint presentations. If a resource that can benefit the entire group is mentioned during the meeting, the program coordinator is responsible for distribution.
The program follows a group facilitated discussion format. Program directors facilitate each meeting, but input is encouraged from all attendees. This model allows for mentees to learn from the faculty mentors as well as peer mentees in a simultaneous and efficient fashion. Group discussions foster collective problem solving, peer support, and resource sharing that would not be possible through individualized mentorship. Participants have access to varied expertise during each session which reduces the need to seek specialized help elsewhere. Participants are also encouraged to contact the program directors or research staff for consultation as needed. Some one-on-one consultations have transitioned to a more sustained and ongoing mentorship relationship between a program director and mentee, but most are often brief email exchanges or a single meeting.
Participants
Since its inception in 2015, 35 clinicians have enrolled in the program. The mentees are equally distributed by sex and practice in a variety of disciplines including gastroenterology, hematology/oncology, cardiology, and general medicine (Table 1). Mentees have submitted 33 grant proposals addressing a variety of health care issues to a diverse group of federal and nonfederal funding agencies (Table 2). As of May 15, 2024, 19 (58%) of the submitted applications have been funded.
Many factors contribute to a successfully funded grant application, and several mentees report that participating in the mentorship program was helpful. For example, a mentee became the first lead investigator for a VA Cooperative Studies Program funded at VAAAHS. The VA Cooperative Studies Program, a division of the Office of Research and Development, plans and conducts large multicenter clinical trials and epidemiological studies within the VA via a vast network of clinician investigators, statisticians, and other key research experts.14
Several program mentees have also received VA Clinical Science Research and Development Career Development Awards. The VA Career Development program supports investigators during their early research careers with a goal of retaining talented researchers committed to improving the health and care of veterans.15
Survey Responses
Mentee productivity and updates are tracked through direct mentee input, as requested by the program coordinator. Since 2022, participants could complete an end-of-year survey based on an assessment tool used in a VAAAHS nonresearch mentorship program.16 The survey, distributed to mentees and program directors, requests feedback on logistics (eg, if the meeting was a good use of time and barriers to attendance); perceptions of effectiveness (eg, ability to discuss agenda items, helpfulness with setting and reaching research goals, and quality of mentors’ feedback); and the impact of the mentoring program on work satisfaction and clinician burnout. Respondents are also encouraged to leave open-ended qualitative feedback.
To date the survey has elicited 19 responses. Seventeen (89%) indicated that they agree or strongly agree the meetings were an effective use of their time and 11 (58%) indicated that they were able to discuss all or most of the items they wanted to during the meeting. Sixteen respondents (84%) agreed the program helped them set and achieve their research goals and 14 respondents (74%) agreed the feedback they received during the meeting was specific, actionable, and focused on how to improve their research agenda. Seventeen respondents (89%) agreed the program increased their work satisfaction, while 13 respondents (68%) felt the program reduced levels of clinician burnout.
As attendance was not mandatory, the survey asked participants how often they attended meetings during the past year. Responses were mixed: 4 (21%) respondents attended regularly (12 to 16 times per year) and 8 (42%) attended most sessions (8 to 11 times per year). Noted barriers to attendance included conflicts with patient care activities and conflicts with other high priority meetings.
Mentees also provided qualitive feedback regarding the program. They highlighted the supportive environment, valuable expertise of the mentors, and usefulness of obtaining tailored feedback from the group. “This group is an amazing resource to anyone developing a research career,” a mentee noted, adding that the program directors “fostered an incredibly supportive group where research ideas and methodology can be explored in a nonthreatening and creative environment.”
Conclusions
This mentorship program aims to help aspiring VA clinician investigators develop and submit competitive research grant applications. The addition of the program to the existing robust research environments at VAAAHS and its academic affiliate appears to have contributed to this success, with 58% of applications submitted by program mentees receiving funding.
In addition to funding success, we also found that most participants have a favorable impression of the program. Of the participants who responded to the program evaluation survey, nearly all indicated the program was an effective use of their time. The program also appeared to increase work satisfaction and reduce levels of clinician burnout. Barriers to attendance were also noted, with the most frequent being scheduling conflicts.
This program’s format includes facilitated group discussion as well as peer mentorship. This collaborative structure allows for an efficient and rich learning experience. Feedback from multiple perspectives encourages natural networking and relationship building. Incorporating the collective wisdom of the faculty mentors and peer mentees is beneficial; it not only empowers the mentees but also enriches the experience for the mentors. This program can serve as a model for other VA facilities—or non-VA academic medical centers—to enhance their research programs.
Supporting meaningful research that has a positive impact on the health and quality of life of veterans is a priority of the US Department of Veterans Affairs Office of Research and Development.1 For nearly a century, VA researchers have been conducting high quality studies. To continue this trajectory, it is imperative to attract, train, and retain exceptional investigators while nurturing their development throughout their careers.2
Mentorship is defined as guidance provided by an experienced and trusted party to another (usually junior) individual with the intent of helping the person succeed. It benefits the mentee, mentor, and their institutions.3 Mentorship is crucial for personal and professional development as well as productivity, which may help reduce clinician burnout.4-7 Conversely, a lack of mentorship could have negative effects on work satisfaction and stagnate career progression.8
Mentorship is vital for developing and advancing a VA investigator’s research agenda. Funding, grant writing, and research design were among the most discussed topics in a large comprehensive mentorship program for academic faculty.9 However, there are several known barriers to effective research mentorship; among them include a lack of resources, time constraints, and competing clinical priorities.10,11
Finding time for effective one-on-one research mentoring is difficult within the time constraints of clinical duties; a group mentorship model may help overcome this barrier. Group mentorship can aid in personal and professional development because no single mentor can effectively meet every mentoring need of an individual.12 Group mentorship also allows for the exchange of ideas among individuals with different backgrounds and the ability to utilize the strengths of each member of the group. For example, a member may have methodological expertise, while another may be skilled in grantsmanship. A team of mentors may be more beneficial for both the mentors (eg, establish a more manageable workload) and the mentee (eg, gains a broader perspective of expertise) when compared to having a single mentor.3
Peer mentorship within the group setting may also yield additional benefits. For example, having a supportive peer group may help reduce stress levels and burnout, while also improving overall well-being.3,13 Formal mentorship programs do not frequently discuss concerns such as work-life balance, so including peers as mentors may help fill this void.9 Peer mentorship has also been found to be beneficial in providing mentees with pooled resources and shared learning.12,13 This article describes the components, benefits, impacts, and challenges of a group research mentorship program for VA clinicians interested in conducting VArelevant research.
Program Description
The VA Clinical Research Mentorship Program was initiated at the VA Ann Arbor Healthcare System (VAAAHS) in October 2015 by the Chief of Medicine to assist VA clinician investigators with developing and submitting VA clinical science and health services research grant applications. The program offers group and one-on-one consultation services through the expertise of 2 experienced investigators/faculty mentors who also serve as program directors, each of whom devote about 3 to 5 hours per month to activities associated with the mentorship program (eg, attending the meeting, reviewing materials sent by mentees, and one-on-one discussions with mentees).
The program also fostered peer-led mentorship. This encourages all attendees to provide feedback during group sessions and communication by mentees outside the group sessions. An experienced project manager serves as program coordinator and contributes about 4 hours per month for activities such as attending, scheduling, and sending reminders for each meeting, distributing handouts, reviewing materials, and answering mentee’s questions via email. A statistician and additional research staff (ie, an epidemiologist and research assistant) do not attend the recurring meetings, but are available for offline consultation as needed. The program runs on a 12-month cycle with regular meetings occurring twice monthly during the 9-month academic period. Resources to support the program, primarily program director(s) and project coordinator effort, are provided by the Chief of Medicine and through the VAAAHS affiliated VA Health Systems Research (formerly Health Services Research & Development) Center of Innovation.
Invitations for new mentees are sent annually. Mentees expressing interest in the program outside of its annual recruitment period are evaluated for inclusion on a rolling basis. Recruitment begins with the program coordinator sending email notifications to all VAAAHS Medicine Service faculty, section chiefs, and division chiefs at the VAAAHS academic affiliate. Recipients are encouraged to distribute the announcement to eligible applicants and refer them to the application materials for entry consideration into the program. The application consists of the applicant’s curriculum vitae and a 1-page summary that includes a description of their research area of interest, how it is relevant to the VA, in addition to an idea for a research study, its potential significance, and proposed methodology. Applicant materials are reviewed by the program coordinator and program directors. The applicants are evaluated using a simple scoring approach that focuses on the applicant’s research area and agenda, past research training, past research productivity, potential for obtaining VA funding, and whether they have sufficient research time.
Program eligibility initially required being a physician with ≥ 1/8 VA appointment from the Medicine Service. However, clinicians with clinical appointments from other VA services are also accepted for participation as needed. Applicants must have previous research experience and have a career goal to obtain external funding for conducting and publishing original research. Those who have previously served as a principal investigator on a funded VA grant proposal are not eligible as new applicants but can remain in the program as peer mentors. The number of annual applicants varies and ranges from 1 to 11; on average, about 90% of applicants receive invitations to join the program.
Sessions
The program holds recurring meetings twice monthly for 1 hour during the 9-month academic year. However, program directors are available year-round, and mentees are encouraged to communicate questions or concerns via email during nonacademic months. Prior to the COVID-19 pandemic, all meetings were held in-person. However, the group pivoted to virtual meetings and continues to utilize this format. The dedicated program coordinator is responsible for coordinating meetings and distributing meeting materials.
Each session is informal, flexible, and supportive. Attendance is not enforced, and mentees are allowed to join meetings as their schedules permit; however, program directors and program coordinator attend each meeting. In advance of each session, the program coordinator sends out a call for agenda items to all active members invited to discuss any research related items. Each mentee presents their ideas to lead the discussion for their portion of the meeting with no defined format required.
A variety of topics are covered including, but not limited to: (1) grant-specific concerns (eg, questions related to specific aim pages, grantsmanship, postsubmission comments from reviewers, or postaward logistics); (2) research procedures (eg, questions related to methodological practices or institutional review board concerns); (3) manuscript or presentation preparation; and (4) careerrelated issues. The program coordinator distributes handouts prior to meetings and mentees may record their presentations. These handouts may include, but are not limited to, specific aims pages, analytical plans, grant solicitations, and PowerPoint presentations. If a resource that can benefit the entire group is mentioned during the meeting, the program coordinator is responsible for distribution.
The program follows a group facilitated discussion format. Program directors facilitate each meeting, but input is encouraged from all attendees. This model allows for mentees to learn from the faculty mentors as well as peer mentees in a simultaneous and efficient fashion. Group discussions foster collective problem solving, peer support, and resource sharing that would not be possible through individualized mentorship. Participants have access to varied expertise during each session which reduces the need to seek specialized help elsewhere. Participants are also encouraged to contact the program directors or research staff for consultation as needed. Some one-on-one consultations have transitioned to a more sustained and ongoing mentorship relationship between a program director and mentee, but most are often brief email exchanges or a single meeting.
Participants
Since its inception in 2015, 35 clinicians have enrolled in the program. The mentees are equally distributed by sex and practice in a variety of disciplines including gastroenterology, hematology/oncology, cardiology, and general medicine (Table 1). Mentees have submitted 33 grant proposals addressing a variety of health care issues to a diverse group of federal and nonfederal funding agencies (Table 2). As of May 15, 2024, 19 (58%) of the submitted applications have been funded.
Many factors contribute to a successfully funded grant application, and several mentees report that participating in the mentorship program was helpful. For example, a mentee became the first lead investigator for a VA Cooperative Studies Program funded at VAAAHS. The VA Cooperative Studies Program, a division of the Office of Research and Development, plans and conducts large multicenter clinical trials and epidemiological studies within the VA via a vast network of clinician investigators, statisticians, and other key research experts.14
Several program mentees have also received VA Clinical Science Research and Development Career Development Awards. The VA Career Development program supports investigators during their early research careers with a goal of retaining talented researchers committed to improving the health and care of veterans.15
Survey Responses
Mentee productivity and updates are tracked through direct mentee input, as requested by the program coordinator. Since 2022, participants could complete an end-of-year survey based on an assessment tool used in a VAAAHS nonresearch mentorship program.16 The survey, distributed to mentees and program directors, requests feedback on logistics (eg, if the meeting was a good use of time and barriers to attendance); perceptions of effectiveness (eg, ability to discuss agenda items, helpfulness with setting and reaching research goals, and quality of mentors’ feedback); and the impact of the mentoring program on work satisfaction and clinician burnout. Respondents are also encouraged to leave open-ended qualitative feedback.
To date the survey has elicited 19 responses. Seventeen (89%) indicated that they agree or strongly agree the meetings were an effective use of their time and 11 (58%) indicated that they were able to discuss all or most of the items they wanted to during the meeting. Sixteen respondents (84%) agreed the program helped them set and achieve their research goals and 14 respondents (74%) agreed the feedback they received during the meeting was specific, actionable, and focused on how to improve their research agenda. Seventeen respondents (89%) agreed the program increased their work satisfaction, while 13 respondents (68%) felt the program reduced levels of clinician burnout.
As attendance was not mandatory, the survey asked participants how often they attended meetings during the past year. Responses were mixed: 4 (21%) respondents attended regularly (12 to 16 times per year) and 8 (42%) attended most sessions (8 to 11 times per year). Noted barriers to attendance included conflicts with patient care activities and conflicts with other high priority meetings.
Mentees also provided qualitive feedback regarding the program. They highlighted the supportive environment, valuable expertise of the mentors, and usefulness of obtaining tailored feedback from the group. “This group is an amazing resource to anyone developing a research career,” a mentee noted, adding that the program directors “fostered an incredibly supportive group where research ideas and methodology can be explored in a nonthreatening and creative environment.”
Conclusions
This mentorship program aims to help aspiring VA clinician investigators develop and submit competitive research grant applications. The addition of the program to the existing robust research environments at VAAAHS and its academic affiliate appears to have contributed to this success, with 58% of applications submitted by program mentees receiving funding.
In addition to funding success, we also found that most participants have a favorable impression of the program. Of the participants who responded to the program evaluation survey, nearly all indicated the program was an effective use of their time. The program also appeared to increase work satisfaction and reduce levels of clinician burnout. Barriers to attendance were also noted, with the most frequent being scheduling conflicts.
This program’s format includes facilitated group discussion as well as peer mentorship. This collaborative structure allows for an efficient and rich learning experience. Feedback from multiple perspectives encourages natural networking and relationship building. Incorporating the collective wisdom of the faculty mentors and peer mentees is beneficial; it not only empowers the mentees but also enriches the experience for the mentors. This program can serve as a model for other VA facilities—or non-VA academic medical centers—to enhance their research programs.
- US Department of Veterans Affairs, Office of Research and Development. Strategic priorities for VA research. Published March 10, 2021. Accessed September 17, 2024. https://www.research.va.gov/about/strategic_priorities.cfm
- . US Department of Veterans Affairs, Office of Research and Development. About the Office of Research & Development. Published November 11, 2023. Accessed September 17, 2024. https://www.research.va.gov/about/default.cfm
- Chopra V, Vaughn V, Saint S. The Mentoring Guide: Helping Mentors and Mentees Succeed. Michigan Publishing Services; 2019.
- Gilster SD, Accorinti KL. Mentoring program yields staff satisfaction. Mentoring through the exchange of information across all organizational levels can help administrators retain valuable staff. Provider. 1999;25(10):99-100.
- Ramanan RA, Phillips RS, Davis RB, Silen W, Reede JY. Mentoring in medicine: keys to satisfaction. Am J Med. 2002;112(4):336-341. doi:10.1016/s0002-9343(02)01032-x
- Sambunjak D, Straus SE, Marusi' A. Mentoring in academic medicine: a systematic review. JAMA. 2006;296(9):1103-1115. doi:10.1001/jama.296.9.1103
- Sambunjak D, Straus SE, Marusi' A. A systematic review of qualitative research on the meaning and characteristics of mentoring in academic medicine. J Gen Intern Med. 2010;25(1):72-78. doi:10.1007/s11606-009-1165-8
- Jackson VA, Palepu A, Szalacha L, Caswell C, Carr PL, Inui T. “Having the right chemistry”: a qualitative study of mentoring in academic medicine. Acad Med. 2003;78(3):328-334. doi:10.1097/00001888-200303000-00020
- Feldman MD, Arean PA, Marshall SJ, Lovett M, O’Sullivan P. Does mentoring matter: results from a survey of faculty mentees at a large health sciences university. Med Educ Online. 2010;15:10.3402/meo.v15i0.5063. doi:10.3402/meo.v15i0.5063
- Leary JC, Schainker EG, Leyenaar JK. The unwritten rules of mentorship: facilitators of and barriers to effective mentorship in pediatric hospital medicine. Hosp Pediatr. 2016;6(4):219-225. doi:10.1542/hpeds.2015-0108
- Rustgi AK, Hecht GA. Mentorship in academic medicine. Gastroenterology. 2011;141(3):789-792. doi:10.1053/j.gastro.2011.07.024
- DeCastro R, Sambuco D, Ubel PA, Stewart A, Jagsi R. Mentor networks in academic medicine: moving beyond a dyadic conception of mentoring for junior faculty researchers. Acad Med. 2013;88(4):488-496. doi:10.1097/ACM.0b013e318285d302
- McDaugall M, Beattie RS. Peer mentoring at work: the nature and outcomes of non-hierarchical developmental relationships. Management Learning. 2016;28(4):423-437. doi:10.1177/1350507697284003
- US Department of Veterans Affairs, Office of Rsearch and Development. VA Cooperative Studies Program (CSP). Updated July 2019. Accessed September 17, 2024. https://www.vacsp.research.va.gov
- US Department of Veterans Affairs, Office of Research and Development. Career development program for biomedical laboratory and clinical science R&D services. Published April 17, 2023. Accessed September 17, 2024. https://www.research.va.gov/services/shared_docs/career_dev.cfm
- Houchens N, Kuhn L, Ratz D, Su G, Saint S. Committed to success: a structured mentoring program for clinically-oriented physicians. Mayo Clin Pro Innov Qual Outcomes. 2024;8(4):356-363. doi:10.1016/j.mayocpiqo.2024.05.002
- US Department of Veterans Affairs, Office of Research and Development. Strategic priorities for VA research. Published March 10, 2021. Accessed September 17, 2024. https://www.research.va.gov/about/strategic_priorities.cfm
- . US Department of Veterans Affairs, Office of Research and Development. About the Office of Research & Development. Published November 11, 2023. Accessed September 17, 2024. https://www.research.va.gov/about/default.cfm
- Chopra V, Vaughn V, Saint S. The Mentoring Guide: Helping Mentors and Mentees Succeed. Michigan Publishing Services; 2019.
- Gilster SD, Accorinti KL. Mentoring program yields staff satisfaction. Mentoring through the exchange of information across all organizational levels can help administrators retain valuable staff. Provider. 1999;25(10):99-100.
- Ramanan RA, Phillips RS, Davis RB, Silen W, Reede JY. Mentoring in medicine: keys to satisfaction. Am J Med. 2002;112(4):336-341. doi:10.1016/s0002-9343(02)01032-x
- Sambunjak D, Straus SE, Marusi' A. Mentoring in academic medicine: a systematic review. JAMA. 2006;296(9):1103-1115. doi:10.1001/jama.296.9.1103
- Sambunjak D, Straus SE, Marusi' A. A systematic review of qualitative research on the meaning and characteristics of mentoring in academic medicine. J Gen Intern Med. 2010;25(1):72-78. doi:10.1007/s11606-009-1165-8
- Jackson VA, Palepu A, Szalacha L, Caswell C, Carr PL, Inui T. “Having the right chemistry”: a qualitative study of mentoring in academic medicine. Acad Med. 2003;78(3):328-334. doi:10.1097/00001888-200303000-00020
- Feldman MD, Arean PA, Marshall SJ, Lovett M, O’Sullivan P. Does mentoring matter: results from a survey of faculty mentees at a large health sciences university. Med Educ Online. 2010;15:10.3402/meo.v15i0.5063. doi:10.3402/meo.v15i0.5063
- Leary JC, Schainker EG, Leyenaar JK. The unwritten rules of mentorship: facilitators of and barriers to effective mentorship in pediatric hospital medicine. Hosp Pediatr. 2016;6(4):219-225. doi:10.1542/hpeds.2015-0108
- Rustgi AK, Hecht GA. Mentorship in academic medicine. Gastroenterology. 2011;141(3):789-792. doi:10.1053/j.gastro.2011.07.024
- DeCastro R, Sambuco D, Ubel PA, Stewart A, Jagsi R. Mentor networks in academic medicine: moving beyond a dyadic conception of mentoring for junior faculty researchers. Acad Med. 2013;88(4):488-496. doi:10.1097/ACM.0b013e318285d302
- McDaugall M, Beattie RS. Peer mentoring at work: the nature and outcomes of non-hierarchical developmental relationships. Management Learning. 2016;28(4):423-437. doi:10.1177/1350507697284003
- US Department of Veterans Affairs, Office of Rsearch and Development. VA Cooperative Studies Program (CSP). Updated July 2019. Accessed September 17, 2024. https://www.vacsp.research.va.gov
- US Department of Veterans Affairs, Office of Research and Development. Career development program for biomedical laboratory and clinical science R&D services. Published April 17, 2023. Accessed September 17, 2024. https://www.research.va.gov/services/shared_docs/career_dev.cfm
- Houchens N, Kuhn L, Ratz D, Su G, Saint S. Committed to success: a structured mentoring program for clinically-oriented physicians. Mayo Clin Pro Innov Qual Outcomes. 2024;8(4):356-363. doi:10.1016/j.mayocpiqo.2024.05.002
A Group Approach to Clinical Research Mentorship at a Veterans Affairs Medical Center
A Group Approach to Clinical Research Mentorship at a Veterans Affairs Medical Center
Vancomycin AUC-Dosing Initiative at a Regional Antibiotic Stewardship Collaborative
Antimicrobial resistance is a global threat and burden to health care, with > 2.8 million antibiotic-resistant infections occurring annually in the United States.1 To combat this issue and improve patient care, the US Department of Veterans Affairs (VA) has implemented antimicrobial stewardship programs (ASPs) across its health care systems. ASPs are multidisciplinary teams that promote evidence-based use of antimicrobials through activities supporting appropriate selection, dosing, route, and duration of antimicrobial therapy. ASP best practices are also included in the Joint Commission and Centers for Medicare and Medicaid Services accreditation standards.2
The foundational charge for VA facilities to develop and maintain ASPs was outlined in 2014 and updated in 2023 in the Veterans Health Administration (VHA) Directive 1031 on antimicrobial stewardship programs.2 This directive outlines specific requirements for all VA ASPs, including personnel, staffing levels, and the roles and responsibilities of all team members. VHA now requires that Veterans Integrated Services Networks (VISNs) establish robust ASP collaboratives. A VISN ASP collaborative consists of stewardship champions from each VA medical center in the VISN and is designed to support, develop, and enhance ASP programs across all facilities within that VISN.2 Some VISNs may lack an ASP collaborative altogether, and others with existing groups may seek ways to expand their collaboratives in line with the updated directive. Prior to VHA Directive 1031, the VA Sunshine Healthcare Network (VISN 8) established an ASP collaborative. This article describes the structure and activities of the VISN 8 ASP collaborative and highlights a recent VISN 8 quality assurance initiative related to vancomycin area under the curve (AUC) dosing that illustrates how ASP collaboratives can enhance stewardship and clinical care across broad geographic areas.
VISN 8 ASP
The VHA, the largest integrated US health care system, is divided into 18 VISNs that provide regional systems of care to enhance access and meet the local health care needs of veterans.3 VISN 8 serves > 1.5 million veterans across 165,759 km2 in Florida, South Georgia, Puerto Rico, and the US Virgin Islands.4 The network is composed of 7 health systems with 8 medical centers and > 60 outpatient clinics. These facilities provide comprehensive acute, primary, and specialty care, as well as mental health and extended care services in inpatient, outpatient, nursing home, and home care settings.4
The 2023 VHA Directive 1031 update recognizes the importance of VISN-level coordination of ASP activities to enhance the standardization of care and build partnerships in stewardship across all levels of care. The VISN 8 ASP collaborative workgroup (ASPWG) was established in 2015. Consistent with Directive 1031, the ASPWG is guided by clinician and pharmacist VISN leads. These leads serve as subject matter experts, facilitate access to resources, establish VISN-level consensus, and enhance communication among local ASP champions at medical centers within the VISN. All 7 health systems include = 1 ASP champion (clinician or pharmacist) in the ASPWG. Ad hoc members, whose routine duties are not solely focused on antimicrobial stewardship, contribute to specific stewardship projects as needed. For example, the ASPWG has included internal medicine, emergency department, community living center pharmacists, representatives from pharmacy administration, and trainees (pharmacy students and residents, and infectious diseases fellows) in antimicrobial stewardship initiatives. The inclusion of non-ASP champions is not discussed in VHA Directive 1031. However, these members have made valuable contributions to the ASPWG.
The ASPWG meets monthly. Agendas and priorities are developed by the VISN pharmacist and health care practitioner (HCP) leads. Monthly discussions may include but are not limited to a review of national formulary decisions, VISN goals and metrics, infectious diseases hot topics, pharmacoeconomic initiatives, strong practice presentations, regulatory and accreditation preparation, preparation of tracking reports, as well as the development of both patient-level and HCPlevel tools, resources, and education materials. This forum facilitates collaborative learning: members process and synthesize information, share and reframe ideas, and listen to other viewpoints to gain a complete understanding as a group.5 For example, ASPWG members have leaned on each other to prepare for Joint Commission accreditation surveys and strengthen the VISN 8 COVID-19 program through the rollout of vaccines and treatments. Other collaborative projects completed over the past few years included a penicillin allergy testing initiative and anti-methicillin-resistant Staphylococcus aureus (MRSA) and pseudomonal medication use evaluations. This team-centric problem-solving approach is highly effective while also fostering professional and social relationships. However, collaboratives could be perceived to have drawbacks. There may be opportunity costs if ASP time is allocated for issues that have already been addressed locally or concerns that standardization might hinder rapid adoption of practices at individual sites. Therefore, participation in each distinct group initiative is optional. This allows sites to choose projects related to their high priority areas and maintain bandwidth to implement practices not yet adopted by the larger group.
The ASPWG tracks metrics related to antimicrobial use with quarterly data presented by the VISN pharmacist lead. Both inpatient and outpatient metrics are evaluated, such as days of therapy per 1000 days and outpatient antibiotic prescriptions per 1000 unique patients. Facilities are benchmarked against their own historical data and other VISN sites, as well as other VISNs across the country. When outliers are identified, facilities are encouraged to conduct local projects to identify reasons for different antimicrobial use patterns and subsequent initiatives to optimize antimicrobial use. Benchmarking against VISN facilities can be useful since VISN facilities may be more similar than facilities in different geographic regions. Each year, the ASPWG reviews the current metrics, makes adjustments to address VISN priorities, and votes for approval of the metrics that will be tracked in the coming year.
Participation in an ASP collaborative streamlines the rollout of ASP and quality improvement initiatives across multiple sites, allowing ASPs to impact a greater number of veterans and evaluate initiatives on a larger scale. In 2019, with the anticipation of revised vancomycin dosing and monitoring guidelines, our ASPWG began to strategize the transition to AUC-based vancomycin monitoring.6 This multisite initiative showcases the strengths of implementing and evaluating practice changes as part of an ASP collaborative.
Vancomycin Dosing
The antibiotic vancomycin is used primarily for the treatment of MRSA infections.6 The 2020 consensus guidelines for vancomycin therapeutic monitoring recommend using the AUC to minimum inhibitory concentration (MIC) ratio as the pharmacodynamic target for serious MRSA infections, with an AUC/MIC goal of 400 to 600 mcg*h/mL.6 Prior guidelines recommended using vancomycin trough concentrations of 15 to 20 mcg/mL as a surrogate for this AUC target. However, subsequent studies have shown that trough-based dosing is associated with higher vancomycin exposures, supratherapeutic AUCs, and increased risk of vancomycin-associated acute kidney injury (AKI).7,8 Therefore, more direct AUC estimation is now recommended.6 The preferred approach for AUC calculations is through Bayesian modeling. Due to limited resources and software availability, many facilities use an alternative method involving 2 postdistributive serum vancomycin concentrations and first-order pharmacokinetic equations. This approach can optimize vancomycin dosing but is more mathematically and logistically challenging. Transitioning from troughto AUC-based vancomycin monitoring requires careful planning and comprehensive staff education.
In 2019, the VISN 8 ASPWG created a comprehensive vancomycin AUC toolkit to facilitate implementation. Components included a pharmacokinetic management policy and procedure, a vancomycin dosing guide, a progress note template, educational materials specific to pharmacy, nursing, laboratory, and medical services, a pharmacist competency examination, and a vancomycin AUC calculator (eAppendix). Each component was developed by a subgroup with the understanding that sites could incorporate variations based on local practices and needs.
The vancomycin AUC calculator was developed to be user-friendly and included safety validation protocols to prevent the entry of erroneous data (eg, unrealistic patient weight or laboratory values). The calculator allowed users to copy data into the electronic health record to avoid manual transcription errors and improve operational efficiency. It offered suggested volume of distribution estimates and 2 methods to estimate elimination constant (Ke ) depending on the patient’s weight.9,10 Creatinine clearance could be estimated using serum creatinine or cystatin C and considered amputation history. The default AUC goal in the calculator was 400 to 550 mcg*h/mL. This range was chosen based on consensus guidelines, data suggesting increased risk of AKI with AUCs > 515 mcg*h/mL, and the preference for conservative empiric dosing in the generally older VA population.11 The calculator suggested loading doses of about 25 mg/kg with a 2500 mg limit. VHA facilities could make limited modifications to the calculator based on local policies and procedures (eg, adjusting default infusion times or a dosing intervals).
The VISN 8 Pharmacy Pharmacokinetic Dosing Manual was developed as a comprehensive document to guide pharmacy staff with dosing vancomycin across diverse patient populations. This document included recommendations for renal function assessment, patient-specific considerations when choosing an empiric vancomycin dose, methods of ordering vancomycin peak, trough, and surveillance levels, dose determination based on 2 levels, and other clinical insights or frequently asked questions.
ASPWG members presented an accredited continuing education webinar for pharmacists, which reviewed the rationale for AUC-targeted dosing, changes to the current pharmacokinetic dosing program, case-based scenarios across various patient populations, and potential challenges associated with vancomycin AUC-based dosing. A recording of the live training was also made available. A vancomycin AUC dosing competency test was developed with 11 basic pharmacokinetic and case-based questions and comprehensive explanations provided for each answer.
VHA facilities implemented AUC dosing in a staggered manner, allowing for lessons learned at earlier adopters to be addressed proactively at later sites. The dosing calculator and education documents were updated iteratively as opportunities for improvement were discovered. ASPWG members held local office hours to address questions or concerns from staff at their facilities. Sharing standardized materials across the VISN reduced individual site workload and complications in rolling out this complex new process.
VISN-WIDE QUALITY ASSURANCE
At the time of project conception, 4 of 7 VISN 8 health systems had transitioned to AUC-based dosing. A quality assurance protocol to compare patient outcomes before and after changing to AUC dosing was developed. Each site followed local protocols for project approval and data were deidentified, collected, and aggregated for analysis.
The primary objectives were to compare the incidence of AKI and persistent bacteremia and assess rates of AUC target attainment (400-600 mcg*h/mL) in the AUC-based and trough-based dosing groups.6 Data for both groups included anthropomorphic measurements, serum creatinine, amputation status, vancomycin dosing, and infection characteristics. The X2 test was used for categorical data and the t test was used for continuous data. A 2-tailed α of 0.05 was used to determine significance. Each site sequentially reviewed all patients receiving ≥ 48 hours of intravenous vancomycin over a 3-month period and contributed up to 50 patients for each group. Due to staggered implementation, the study periods for sites spanned 2018 to 2023. A minimum 6-month washout period was observed between the trough and AUC groups at each site. Patients were excluded if pregnant, receiving renal replacement therapy, or presenting with AKI at the time of vancomycin initiation.
There were 168 patients in the AUC group and 172 patients in the trough group (Table 1). The rate of AUC target attainment with the initial dosing regimen varied across sites from 18% to 69% (mean, 48%). Total daily vancomycin exposure was lower in the AUC group compared with the trough group (2402 mg vs 2605 mg, respectively), with AUC-dosed patients being less likely to experience troughs level ≥ 15 or 20 mcg/mL (Table 2). There was a statistically significant lower rate of AKI in the AUC group: 2.4% in the AUC group (range, 2%-3%) vs 10.4% (range 7%-12%) in the trough group (P = .002). Rates of AKI were comparable to those observed in previous interventions.6 There was no statistical difference in length of stay, time to blood culture clearance, or rate of persistent bacteremia in the 2 groups, but these assessments were limited by sample size.
We did not anticipate such variability in initial target attainment across sites. The multisite quality assurance design allowed for qualitative evaluation of variability in dosing practices, which likely arose from sites and individual pharmacists having some flexibility in adjusting dosing tool parameters. Further analysis revealed that the facility with low initial target attainment was not routinely utilizing vancomycin loading doses. Sites routinely use robust loading doses achieved earlier and more consistent target attainment. Some sites used a narrower AUC target range in certain clinical scenarios (eg, > 500 mcg*h/mL for septic patients and < 500 mcg*h/mL for patients with less severe infections) rather than the 400 to 550 mcg*h/mL range for all patients. Sites targeting broader AUC ranges for all patients had higher rates of target attainment. Reviewing differences among sites allowed the ASPWG to identify best practices to optimize future care.
CONCLUSIONS
VHA ASPs must meet the standards outlined in VHA Directive 1031, including the new requirement for each VISN to develop an ASP collaborative. The VISN 8 ASPWG demonstrates how ASP champions can collaborate to solve common issues, complete tasks, explore new infectious diseases concepts, and impact large veteran populations. Furthermore, ASP collaboratives can harness their collective size to complete robust quality assurance evaluations that might otherwise be underpowered if completed at a single center. A limitation of the collaborative model is that a site with a robust ASP may already have specific practices in place. Expanding the ASP collaborative model further highlights the VHA role as a nationwide leader in ASP best practices.
- Centers for Disease Control and Prevention. Antibiotic resistance threats in the United States, 2019. Updated December 2019. Accessed September 10, 2024. https:// www.cdc.gov/antimicrobial-resistance/media/pdfs/2019-ar-threats-report-508.pdf
- US Department of Veterans Affairs. Antimicrobial stewardship programs. Updated September 22, 2023. Accessed September 13, 2024. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=11458
- US Department of Veterans Affairs, Veteran Health Administration. Veterans Integrated Service Networks (VISNs). Accessed September 13, 2024. https://www.va.gov/HEALTH/visns.asp
- US Department of Veterans Affairs. Veterans Health Administration, Veterans Integrated Service Networks, VISN 08. Updated September 10, 2024. Accessed September 13, 2024. https://department.va.gov/integrated-service-networks/visn-08/
- Andreev I. What is collaborative learning? Theory, examples of activities. Valamis. Updated July 10, 2024. Accessed September 10, 2024. https://www.valamis.com/hub/collaborative-learning
- Rybak MJ, Le J, Lodise TP, et al. Therapeutic monitoring of vancomycin for serious methicillin-resistant staphylococcus aureus infections: a revised consensus guideline and review by the American Society of Health-System Pharmacists, the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, and the Society of Infectious Diseases Pharmacists. Am J Health Syst Pharm. 2020;77(11):835-864. doi:10.1093/ajhp/zxaa036
- Finch NA, Zasowski EJ, Murray KP, et al. A quasi-experiment to study the impact of vancomycin area under the concentration-time curve-guided dosing on vancomycinassociated nephrotoxicity. Antimicrob Agents Chemother. 2017;61(12):e01293-17. doi:10.1128/AAC.01293-17
- Zasowski EJ, Murray KP, Trinh TD, et al. Identification of vancomycin exposure-toxicity thresholds in hospitalized patients receiving intravenous vancomycin. Antimicrob Agents Chemother. 2017;62(1):e01684-17. doi:10.1128/AAC.01684-17
- Matzke GR, Kovarik JM, Rybak MJ, Boike SC. Evaluation of the vancomycin-clearance: creatinine-clearance relationship for predicting vancomycin dosage. Clin Pharm. 1985;4(3):311-315.
- Crass RL, Dunn R, Hong J, Krop LC, Pai MP. Dosing vancomycin in the super obese: less is more. J Antimicrob Chemother. 2018;73(11):3081-3086. doi:10.1093/jac/dky310
- Lodise TP, Rosenkranz SL, Finnemeyer M, et al. The emperor’s new clothes: prospective observational evaluation of the association between initial vancomycIn exposure and failure rates among adult hospitalized patients with methicillin-resistant staphylococcus aureus bloodstream infections (PROVIDE). Clin Infect Dis. 2020;70(8):1536-1545. doi:10.1093/cid/ciz460
Antimicrobial resistance is a global threat and burden to health care, with > 2.8 million antibiotic-resistant infections occurring annually in the United States.1 To combat this issue and improve patient care, the US Department of Veterans Affairs (VA) has implemented antimicrobial stewardship programs (ASPs) across its health care systems. ASPs are multidisciplinary teams that promote evidence-based use of antimicrobials through activities supporting appropriate selection, dosing, route, and duration of antimicrobial therapy. ASP best practices are also included in the Joint Commission and Centers for Medicare and Medicaid Services accreditation standards.2
The foundational charge for VA facilities to develop and maintain ASPs was outlined in 2014 and updated in 2023 in the Veterans Health Administration (VHA) Directive 1031 on antimicrobial stewardship programs.2 This directive outlines specific requirements for all VA ASPs, including personnel, staffing levels, and the roles and responsibilities of all team members. VHA now requires that Veterans Integrated Services Networks (VISNs) establish robust ASP collaboratives. A VISN ASP collaborative consists of stewardship champions from each VA medical center in the VISN and is designed to support, develop, and enhance ASP programs across all facilities within that VISN.2 Some VISNs may lack an ASP collaborative altogether, and others with existing groups may seek ways to expand their collaboratives in line with the updated directive. Prior to VHA Directive 1031, the VA Sunshine Healthcare Network (VISN 8) established an ASP collaborative. This article describes the structure and activities of the VISN 8 ASP collaborative and highlights a recent VISN 8 quality assurance initiative related to vancomycin area under the curve (AUC) dosing that illustrates how ASP collaboratives can enhance stewardship and clinical care across broad geographic areas.
VISN 8 ASP
The VHA, the largest integrated US health care system, is divided into 18 VISNs that provide regional systems of care to enhance access and meet the local health care needs of veterans.3 VISN 8 serves > 1.5 million veterans across 165,759 km2 in Florida, South Georgia, Puerto Rico, and the US Virgin Islands.4 The network is composed of 7 health systems with 8 medical centers and > 60 outpatient clinics. These facilities provide comprehensive acute, primary, and specialty care, as well as mental health and extended care services in inpatient, outpatient, nursing home, and home care settings.4
The 2023 VHA Directive 1031 update recognizes the importance of VISN-level coordination of ASP activities to enhance the standardization of care and build partnerships in stewardship across all levels of care. The VISN 8 ASP collaborative workgroup (ASPWG) was established in 2015. Consistent with Directive 1031, the ASPWG is guided by clinician and pharmacist VISN leads. These leads serve as subject matter experts, facilitate access to resources, establish VISN-level consensus, and enhance communication among local ASP champions at medical centers within the VISN. All 7 health systems include = 1 ASP champion (clinician or pharmacist) in the ASPWG. Ad hoc members, whose routine duties are not solely focused on antimicrobial stewardship, contribute to specific stewardship projects as needed. For example, the ASPWG has included internal medicine, emergency department, community living center pharmacists, representatives from pharmacy administration, and trainees (pharmacy students and residents, and infectious diseases fellows) in antimicrobial stewardship initiatives. The inclusion of non-ASP champions is not discussed in VHA Directive 1031. However, these members have made valuable contributions to the ASPWG.
The ASPWG meets monthly. Agendas and priorities are developed by the VISN pharmacist and health care practitioner (HCP) leads. Monthly discussions may include but are not limited to a review of national formulary decisions, VISN goals and metrics, infectious diseases hot topics, pharmacoeconomic initiatives, strong practice presentations, regulatory and accreditation preparation, preparation of tracking reports, as well as the development of both patient-level and HCPlevel tools, resources, and education materials. This forum facilitates collaborative learning: members process and synthesize information, share and reframe ideas, and listen to other viewpoints to gain a complete understanding as a group.5 For example, ASPWG members have leaned on each other to prepare for Joint Commission accreditation surveys and strengthen the VISN 8 COVID-19 program through the rollout of vaccines and treatments. Other collaborative projects completed over the past few years included a penicillin allergy testing initiative and anti-methicillin-resistant Staphylococcus aureus (MRSA) and pseudomonal medication use evaluations. This team-centric problem-solving approach is highly effective while also fostering professional and social relationships. However, collaboratives could be perceived to have drawbacks. There may be opportunity costs if ASP time is allocated for issues that have already been addressed locally or concerns that standardization might hinder rapid adoption of practices at individual sites. Therefore, participation in each distinct group initiative is optional. This allows sites to choose projects related to their high priority areas and maintain bandwidth to implement practices not yet adopted by the larger group.
The ASPWG tracks metrics related to antimicrobial use with quarterly data presented by the VISN pharmacist lead. Both inpatient and outpatient metrics are evaluated, such as days of therapy per 1000 days and outpatient antibiotic prescriptions per 1000 unique patients. Facilities are benchmarked against their own historical data and other VISN sites, as well as other VISNs across the country. When outliers are identified, facilities are encouraged to conduct local projects to identify reasons for different antimicrobial use patterns and subsequent initiatives to optimize antimicrobial use. Benchmarking against VISN facilities can be useful since VISN facilities may be more similar than facilities in different geographic regions. Each year, the ASPWG reviews the current metrics, makes adjustments to address VISN priorities, and votes for approval of the metrics that will be tracked in the coming year.
Participation in an ASP collaborative streamlines the rollout of ASP and quality improvement initiatives across multiple sites, allowing ASPs to impact a greater number of veterans and evaluate initiatives on a larger scale. In 2019, with the anticipation of revised vancomycin dosing and monitoring guidelines, our ASPWG began to strategize the transition to AUC-based vancomycin monitoring.6 This multisite initiative showcases the strengths of implementing and evaluating practice changes as part of an ASP collaborative.
Vancomycin Dosing
The antibiotic vancomycin is used primarily for the treatment of MRSA infections.6 The 2020 consensus guidelines for vancomycin therapeutic monitoring recommend using the AUC to minimum inhibitory concentration (MIC) ratio as the pharmacodynamic target for serious MRSA infections, with an AUC/MIC goal of 400 to 600 mcg*h/mL.6 Prior guidelines recommended using vancomycin trough concentrations of 15 to 20 mcg/mL as a surrogate for this AUC target. However, subsequent studies have shown that trough-based dosing is associated with higher vancomycin exposures, supratherapeutic AUCs, and increased risk of vancomycin-associated acute kidney injury (AKI).7,8 Therefore, more direct AUC estimation is now recommended.6 The preferred approach for AUC calculations is through Bayesian modeling. Due to limited resources and software availability, many facilities use an alternative method involving 2 postdistributive serum vancomycin concentrations and first-order pharmacokinetic equations. This approach can optimize vancomycin dosing but is more mathematically and logistically challenging. Transitioning from troughto AUC-based vancomycin monitoring requires careful planning and comprehensive staff education.
In 2019, the VISN 8 ASPWG created a comprehensive vancomycin AUC toolkit to facilitate implementation. Components included a pharmacokinetic management policy and procedure, a vancomycin dosing guide, a progress note template, educational materials specific to pharmacy, nursing, laboratory, and medical services, a pharmacist competency examination, and a vancomycin AUC calculator (eAppendix). Each component was developed by a subgroup with the understanding that sites could incorporate variations based on local practices and needs.
The vancomycin AUC calculator was developed to be user-friendly and included safety validation protocols to prevent the entry of erroneous data (eg, unrealistic patient weight or laboratory values). The calculator allowed users to copy data into the electronic health record to avoid manual transcription errors and improve operational efficiency. It offered suggested volume of distribution estimates and 2 methods to estimate elimination constant (Ke ) depending on the patient’s weight.9,10 Creatinine clearance could be estimated using serum creatinine or cystatin C and considered amputation history. The default AUC goal in the calculator was 400 to 550 mcg*h/mL. This range was chosen based on consensus guidelines, data suggesting increased risk of AKI with AUCs > 515 mcg*h/mL, and the preference for conservative empiric dosing in the generally older VA population.11 The calculator suggested loading doses of about 25 mg/kg with a 2500 mg limit. VHA facilities could make limited modifications to the calculator based on local policies and procedures (eg, adjusting default infusion times or a dosing intervals).
The VISN 8 Pharmacy Pharmacokinetic Dosing Manual was developed as a comprehensive document to guide pharmacy staff with dosing vancomycin across diverse patient populations. This document included recommendations for renal function assessment, patient-specific considerations when choosing an empiric vancomycin dose, methods of ordering vancomycin peak, trough, and surveillance levels, dose determination based on 2 levels, and other clinical insights or frequently asked questions.
ASPWG members presented an accredited continuing education webinar for pharmacists, which reviewed the rationale for AUC-targeted dosing, changes to the current pharmacokinetic dosing program, case-based scenarios across various patient populations, and potential challenges associated with vancomycin AUC-based dosing. A recording of the live training was also made available. A vancomycin AUC dosing competency test was developed with 11 basic pharmacokinetic and case-based questions and comprehensive explanations provided for each answer.
VHA facilities implemented AUC dosing in a staggered manner, allowing for lessons learned at earlier adopters to be addressed proactively at later sites. The dosing calculator and education documents were updated iteratively as opportunities for improvement were discovered. ASPWG members held local office hours to address questions or concerns from staff at their facilities. Sharing standardized materials across the VISN reduced individual site workload and complications in rolling out this complex new process.
VISN-WIDE QUALITY ASSURANCE
At the time of project conception, 4 of 7 VISN 8 health systems had transitioned to AUC-based dosing. A quality assurance protocol to compare patient outcomes before and after changing to AUC dosing was developed. Each site followed local protocols for project approval and data were deidentified, collected, and aggregated for analysis.
The primary objectives were to compare the incidence of AKI and persistent bacteremia and assess rates of AUC target attainment (400-600 mcg*h/mL) in the AUC-based and trough-based dosing groups.6 Data for both groups included anthropomorphic measurements, serum creatinine, amputation status, vancomycin dosing, and infection characteristics. The X2 test was used for categorical data and the t test was used for continuous data. A 2-tailed α of 0.05 was used to determine significance. Each site sequentially reviewed all patients receiving ≥ 48 hours of intravenous vancomycin over a 3-month period and contributed up to 50 patients for each group. Due to staggered implementation, the study periods for sites spanned 2018 to 2023. A minimum 6-month washout period was observed between the trough and AUC groups at each site. Patients were excluded if pregnant, receiving renal replacement therapy, or presenting with AKI at the time of vancomycin initiation.
There were 168 patients in the AUC group and 172 patients in the trough group (Table 1). The rate of AUC target attainment with the initial dosing regimen varied across sites from 18% to 69% (mean, 48%). Total daily vancomycin exposure was lower in the AUC group compared with the trough group (2402 mg vs 2605 mg, respectively), with AUC-dosed patients being less likely to experience troughs level ≥ 15 or 20 mcg/mL (Table 2). There was a statistically significant lower rate of AKI in the AUC group: 2.4% in the AUC group (range, 2%-3%) vs 10.4% (range 7%-12%) in the trough group (P = .002). Rates of AKI were comparable to those observed in previous interventions.6 There was no statistical difference in length of stay, time to blood culture clearance, or rate of persistent bacteremia in the 2 groups, but these assessments were limited by sample size.
We did not anticipate such variability in initial target attainment across sites. The multisite quality assurance design allowed for qualitative evaluation of variability in dosing practices, which likely arose from sites and individual pharmacists having some flexibility in adjusting dosing tool parameters. Further analysis revealed that the facility with low initial target attainment was not routinely utilizing vancomycin loading doses. Sites routinely use robust loading doses achieved earlier and more consistent target attainment. Some sites used a narrower AUC target range in certain clinical scenarios (eg, > 500 mcg*h/mL for septic patients and < 500 mcg*h/mL for patients with less severe infections) rather than the 400 to 550 mcg*h/mL range for all patients. Sites targeting broader AUC ranges for all patients had higher rates of target attainment. Reviewing differences among sites allowed the ASPWG to identify best practices to optimize future care.
CONCLUSIONS
VHA ASPs must meet the standards outlined in VHA Directive 1031, including the new requirement for each VISN to develop an ASP collaborative. The VISN 8 ASPWG demonstrates how ASP champions can collaborate to solve common issues, complete tasks, explore new infectious diseases concepts, and impact large veteran populations. Furthermore, ASP collaboratives can harness their collective size to complete robust quality assurance evaluations that might otherwise be underpowered if completed at a single center. A limitation of the collaborative model is that a site with a robust ASP may already have specific practices in place. Expanding the ASP collaborative model further highlights the VHA role as a nationwide leader in ASP best practices.
Antimicrobial resistance is a global threat and burden to health care, with > 2.8 million antibiotic-resistant infections occurring annually in the United States.1 To combat this issue and improve patient care, the US Department of Veterans Affairs (VA) has implemented antimicrobial stewardship programs (ASPs) across its health care systems. ASPs are multidisciplinary teams that promote evidence-based use of antimicrobials through activities supporting appropriate selection, dosing, route, and duration of antimicrobial therapy. ASP best practices are also included in the Joint Commission and Centers for Medicare and Medicaid Services accreditation standards.2
The foundational charge for VA facilities to develop and maintain ASPs was outlined in 2014 and updated in 2023 in the Veterans Health Administration (VHA) Directive 1031 on antimicrobial stewardship programs.2 This directive outlines specific requirements for all VA ASPs, including personnel, staffing levels, and the roles and responsibilities of all team members. VHA now requires that Veterans Integrated Services Networks (VISNs) establish robust ASP collaboratives. A VISN ASP collaborative consists of stewardship champions from each VA medical center in the VISN and is designed to support, develop, and enhance ASP programs across all facilities within that VISN.2 Some VISNs may lack an ASP collaborative altogether, and others with existing groups may seek ways to expand their collaboratives in line with the updated directive. Prior to VHA Directive 1031, the VA Sunshine Healthcare Network (VISN 8) established an ASP collaborative. This article describes the structure and activities of the VISN 8 ASP collaborative and highlights a recent VISN 8 quality assurance initiative related to vancomycin area under the curve (AUC) dosing that illustrates how ASP collaboratives can enhance stewardship and clinical care across broad geographic areas.
VISN 8 ASP
The VHA, the largest integrated US health care system, is divided into 18 VISNs that provide regional systems of care to enhance access and meet the local health care needs of veterans.3 VISN 8 serves > 1.5 million veterans across 165,759 km2 in Florida, South Georgia, Puerto Rico, and the US Virgin Islands.4 The network is composed of 7 health systems with 8 medical centers and > 60 outpatient clinics. These facilities provide comprehensive acute, primary, and specialty care, as well as mental health and extended care services in inpatient, outpatient, nursing home, and home care settings.4
The 2023 VHA Directive 1031 update recognizes the importance of VISN-level coordination of ASP activities to enhance the standardization of care and build partnerships in stewardship across all levels of care. The VISN 8 ASP collaborative workgroup (ASPWG) was established in 2015. Consistent with Directive 1031, the ASPWG is guided by clinician and pharmacist VISN leads. These leads serve as subject matter experts, facilitate access to resources, establish VISN-level consensus, and enhance communication among local ASP champions at medical centers within the VISN. All 7 health systems include = 1 ASP champion (clinician or pharmacist) in the ASPWG. Ad hoc members, whose routine duties are not solely focused on antimicrobial stewardship, contribute to specific stewardship projects as needed. For example, the ASPWG has included internal medicine, emergency department, community living center pharmacists, representatives from pharmacy administration, and trainees (pharmacy students and residents, and infectious diseases fellows) in antimicrobial stewardship initiatives. The inclusion of non-ASP champions is not discussed in VHA Directive 1031. However, these members have made valuable contributions to the ASPWG.
The ASPWG meets monthly. Agendas and priorities are developed by the VISN pharmacist and health care practitioner (HCP) leads. Monthly discussions may include but are not limited to a review of national formulary decisions, VISN goals and metrics, infectious diseases hot topics, pharmacoeconomic initiatives, strong practice presentations, regulatory and accreditation preparation, preparation of tracking reports, as well as the development of both patient-level and HCPlevel tools, resources, and education materials. This forum facilitates collaborative learning: members process and synthesize information, share and reframe ideas, and listen to other viewpoints to gain a complete understanding as a group.5 For example, ASPWG members have leaned on each other to prepare for Joint Commission accreditation surveys and strengthen the VISN 8 COVID-19 program through the rollout of vaccines and treatments. Other collaborative projects completed over the past few years included a penicillin allergy testing initiative and anti-methicillin-resistant Staphylococcus aureus (MRSA) and pseudomonal medication use evaluations. This team-centric problem-solving approach is highly effective while also fostering professional and social relationships. However, collaboratives could be perceived to have drawbacks. There may be opportunity costs if ASP time is allocated for issues that have already been addressed locally or concerns that standardization might hinder rapid adoption of practices at individual sites. Therefore, participation in each distinct group initiative is optional. This allows sites to choose projects related to their high priority areas and maintain bandwidth to implement practices not yet adopted by the larger group.
The ASPWG tracks metrics related to antimicrobial use with quarterly data presented by the VISN pharmacist lead. Both inpatient and outpatient metrics are evaluated, such as days of therapy per 1000 days and outpatient antibiotic prescriptions per 1000 unique patients. Facilities are benchmarked against their own historical data and other VISN sites, as well as other VISNs across the country. When outliers are identified, facilities are encouraged to conduct local projects to identify reasons for different antimicrobial use patterns and subsequent initiatives to optimize antimicrobial use. Benchmarking against VISN facilities can be useful since VISN facilities may be more similar than facilities in different geographic regions. Each year, the ASPWG reviews the current metrics, makes adjustments to address VISN priorities, and votes for approval of the metrics that will be tracked in the coming year.
Participation in an ASP collaborative streamlines the rollout of ASP and quality improvement initiatives across multiple sites, allowing ASPs to impact a greater number of veterans and evaluate initiatives on a larger scale. In 2019, with the anticipation of revised vancomycin dosing and monitoring guidelines, our ASPWG began to strategize the transition to AUC-based vancomycin monitoring.6 This multisite initiative showcases the strengths of implementing and evaluating practice changes as part of an ASP collaborative.
Vancomycin Dosing
The antibiotic vancomycin is used primarily for the treatment of MRSA infections.6 The 2020 consensus guidelines for vancomycin therapeutic monitoring recommend using the AUC to minimum inhibitory concentration (MIC) ratio as the pharmacodynamic target for serious MRSA infections, with an AUC/MIC goal of 400 to 600 mcg*h/mL.6 Prior guidelines recommended using vancomycin trough concentrations of 15 to 20 mcg/mL as a surrogate for this AUC target. However, subsequent studies have shown that trough-based dosing is associated with higher vancomycin exposures, supratherapeutic AUCs, and increased risk of vancomycin-associated acute kidney injury (AKI).7,8 Therefore, more direct AUC estimation is now recommended.6 The preferred approach for AUC calculations is through Bayesian modeling. Due to limited resources and software availability, many facilities use an alternative method involving 2 postdistributive serum vancomycin concentrations and first-order pharmacokinetic equations. This approach can optimize vancomycin dosing but is more mathematically and logistically challenging. Transitioning from troughto AUC-based vancomycin monitoring requires careful planning and comprehensive staff education.
In 2019, the VISN 8 ASPWG created a comprehensive vancomycin AUC toolkit to facilitate implementation. Components included a pharmacokinetic management policy and procedure, a vancomycin dosing guide, a progress note template, educational materials specific to pharmacy, nursing, laboratory, and medical services, a pharmacist competency examination, and a vancomycin AUC calculator (eAppendix). Each component was developed by a subgroup with the understanding that sites could incorporate variations based on local practices and needs.
The vancomycin AUC calculator was developed to be user-friendly and included safety validation protocols to prevent the entry of erroneous data (eg, unrealistic patient weight or laboratory values). The calculator allowed users to copy data into the electronic health record to avoid manual transcription errors and improve operational efficiency. It offered suggested volume of distribution estimates and 2 methods to estimate elimination constant (Ke ) depending on the patient’s weight.9,10 Creatinine clearance could be estimated using serum creatinine or cystatin C and considered amputation history. The default AUC goal in the calculator was 400 to 550 mcg*h/mL. This range was chosen based on consensus guidelines, data suggesting increased risk of AKI with AUCs > 515 mcg*h/mL, and the preference for conservative empiric dosing in the generally older VA population.11 The calculator suggested loading doses of about 25 mg/kg with a 2500 mg limit. VHA facilities could make limited modifications to the calculator based on local policies and procedures (eg, adjusting default infusion times or a dosing intervals).
The VISN 8 Pharmacy Pharmacokinetic Dosing Manual was developed as a comprehensive document to guide pharmacy staff with dosing vancomycin across diverse patient populations. This document included recommendations for renal function assessment, patient-specific considerations when choosing an empiric vancomycin dose, methods of ordering vancomycin peak, trough, and surveillance levels, dose determination based on 2 levels, and other clinical insights or frequently asked questions.
ASPWG members presented an accredited continuing education webinar for pharmacists, which reviewed the rationale for AUC-targeted dosing, changes to the current pharmacokinetic dosing program, case-based scenarios across various patient populations, and potential challenges associated with vancomycin AUC-based dosing. A recording of the live training was also made available. A vancomycin AUC dosing competency test was developed with 11 basic pharmacokinetic and case-based questions and comprehensive explanations provided for each answer.
VHA facilities implemented AUC dosing in a staggered manner, allowing for lessons learned at earlier adopters to be addressed proactively at later sites. The dosing calculator and education documents were updated iteratively as opportunities for improvement were discovered. ASPWG members held local office hours to address questions or concerns from staff at their facilities. Sharing standardized materials across the VISN reduced individual site workload and complications in rolling out this complex new process.
VISN-WIDE QUALITY ASSURANCE
At the time of project conception, 4 of 7 VISN 8 health systems had transitioned to AUC-based dosing. A quality assurance protocol to compare patient outcomes before and after changing to AUC dosing was developed. Each site followed local protocols for project approval and data were deidentified, collected, and aggregated for analysis.
The primary objectives were to compare the incidence of AKI and persistent bacteremia and assess rates of AUC target attainment (400-600 mcg*h/mL) in the AUC-based and trough-based dosing groups.6 Data for both groups included anthropomorphic measurements, serum creatinine, amputation status, vancomycin dosing, and infection characteristics. The X2 test was used for categorical data and the t test was used for continuous data. A 2-tailed α of 0.05 was used to determine significance. Each site sequentially reviewed all patients receiving ≥ 48 hours of intravenous vancomycin over a 3-month period and contributed up to 50 patients for each group. Due to staggered implementation, the study periods for sites spanned 2018 to 2023. A minimum 6-month washout period was observed between the trough and AUC groups at each site. Patients were excluded if pregnant, receiving renal replacement therapy, or presenting with AKI at the time of vancomycin initiation.
There were 168 patients in the AUC group and 172 patients in the trough group (Table 1). The rate of AUC target attainment with the initial dosing regimen varied across sites from 18% to 69% (mean, 48%). Total daily vancomycin exposure was lower in the AUC group compared with the trough group (2402 mg vs 2605 mg, respectively), with AUC-dosed patients being less likely to experience troughs level ≥ 15 or 20 mcg/mL (Table 2). There was a statistically significant lower rate of AKI in the AUC group: 2.4% in the AUC group (range, 2%-3%) vs 10.4% (range 7%-12%) in the trough group (P = .002). Rates of AKI were comparable to those observed in previous interventions.6 There was no statistical difference in length of stay, time to blood culture clearance, or rate of persistent bacteremia in the 2 groups, but these assessments were limited by sample size.
We did not anticipate such variability in initial target attainment across sites. The multisite quality assurance design allowed for qualitative evaluation of variability in dosing practices, which likely arose from sites and individual pharmacists having some flexibility in adjusting dosing tool parameters. Further analysis revealed that the facility with low initial target attainment was not routinely utilizing vancomycin loading doses. Sites routinely use robust loading doses achieved earlier and more consistent target attainment. Some sites used a narrower AUC target range in certain clinical scenarios (eg, > 500 mcg*h/mL for septic patients and < 500 mcg*h/mL for patients with less severe infections) rather than the 400 to 550 mcg*h/mL range for all patients. Sites targeting broader AUC ranges for all patients had higher rates of target attainment. Reviewing differences among sites allowed the ASPWG to identify best practices to optimize future care.
CONCLUSIONS
VHA ASPs must meet the standards outlined in VHA Directive 1031, including the new requirement for each VISN to develop an ASP collaborative. The VISN 8 ASPWG demonstrates how ASP champions can collaborate to solve common issues, complete tasks, explore new infectious diseases concepts, and impact large veteran populations. Furthermore, ASP collaboratives can harness their collective size to complete robust quality assurance evaluations that might otherwise be underpowered if completed at a single center. A limitation of the collaborative model is that a site with a robust ASP may already have specific practices in place. Expanding the ASP collaborative model further highlights the VHA role as a nationwide leader in ASP best practices.
- Centers for Disease Control and Prevention. Antibiotic resistance threats in the United States, 2019. Updated December 2019. Accessed September 10, 2024. https:// www.cdc.gov/antimicrobial-resistance/media/pdfs/2019-ar-threats-report-508.pdf
- US Department of Veterans Affairs. Antimicrobial stewardship programs. Updated September 22, 2023. Accessed September 13, 2024. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=11458
- US Department of Veterans Affairs, Veteran Health Administration. Veterans Integrated Service Networks (VISNs). Accessed September 13, 2024. https://www.va.gov/HEALTH/visns.asp
- US Department of Veterans Affairs. Veterans Health Administration, Veterans Integrated Service Networks, VISN 08. Updated September 10, 2024. Accessed September 13, 2024. https://department.va.gov/integrated-service-networks/visn-08/
- Andreev I. What is collaborative learning? Theory, examples of activities. Valamis. Updated July 10, 2024. Accessed September 10, 2024. https://www.valamis.com/hub/collaborative-learning
- Rybak MJ, Le J, Lodise TP, et al. Therapeutic monitoring of vancomycin for serious methicillin-resistant staphylococcus aureus infections: a revised consensus guideline and review by the American Society of Health-System Pharmacists, the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, and the Society of Infectious Diseases Pharmacists. Am J Health Syst Pharm. 2020;77(11):835-864. doi:10.1093/ajhp/zxaa036
- Finch NA, Zasowski EJ, Murray KP, et al. A quasi-experiment to study the impact of vancomycin area under the concentration-time curve-guided dosing on vancomycinassociated nephrotoxicity. Antimicrob Agents Chemother. 2017;61(12):e01293-17. doi:10.1128/AAC.01293-17
- Zasowski EJ, Murray KP, Trinh TD, et al. Identification of vancomycin exposure-toxicity thresholds in hospitalized patients receiving intravenous vancomycin. Antimicrob Agents Chemother. 2017;62(1):e01684-17. doi:10.1128/AAC.01684-17
- Matzke GR, Kovarik JM, Rybak MJ, Boike SC. Evaluation of the vancomycin-clearance: creatinine-clearance relationship for predicting vancomycin dosage. Clin Pharm. 1985;4(3):311-315.
- Crass RL, Dunn R, Hong J, Krop LC, Pai MP. Dosing vancomycin in the super obese: less is more. J Antimicrob Chemother. 2018;73(11):3081-3086. doi:10.1093/jac/dky310
- Lodise TP, Rosenkranz SL, Finnemeyer M, et al. The emperor’s new clothes: prospective observational evaluation of the association between initial vancomycIn exposure and failure rates among adult hospitalized patients with methicillin-resistant staphylococcus aureus bloodstream infections (PROVIDE). Clin Infect Dis. 2020;70(8):1536-1545. doi:10.1093/cid/ciz460
- Centers for Disease Control and Prevention. Antibiotic resistance threats in the United States, 2019. Updated December 2019. Accessed September 10, 2024. https:// www.cdc.gov/antimicrobial-resistance/media/pdfs/2019-ar-threats-report-508.pdf
- US Department of Veterans Affairs. Antimicrobial stewardship programs. Updated September 22, 2023. Accessed September 13, 2024. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=11458
- US Department of Veterans Affairs, Veteran Health Administration. Veterans Integrated Service Networks (VISNs). Accessed September 13, 2024. https://www.va.gov/HEALTH/visns.asp
- US Department of Veterans Affairs. Veterans Health Administration, Veterans Integrated Service Networks, VISN 08. Updated September 10, 2024. Accessed September 13, 2024. https://department.va.gov/integrated-service-networks/visn-08/
- Andreev I. What is collaborative learning? Theory, examples of activities. Valamis. Updated July 10, 2024. Accessed September 10, 2024. https://www.valamis.com/hub/collaborative-learning
- Rybak MJ, Le J, Lodise TP, et al. Therapeutic monitoring of vancomycin for serious methicillin-resistant staphylococcus aureus infections: a revised consensus guideline and review by the American Society of Health-System Pharmacists, the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, and the Society of Infectious Diseases Pharmacists. Am J Health Syst Pharm. 2020;77(11):835-864. doi:10.1093/ajhp/zxaa036
- Finch NA, Zasowski EJ, Murray KP, et al. A quasi-experiment to study the impact of vancomycin area under the concentration-time curve-guided dosing on vancomycinassociated nephrotoxicity. Antimicrob Agents Chemother. 2017;61(12):e01293-17. doi:10.1128/AAC.01293-17
- Zasowski EJ, Murray KP, Trinh TD, et al. Identification of vancomycin exposure-toxicity thresholds in hospitalized patients receiving intravenous vancomycin. Antimicrob Agents Chemother. 2017;62(1):e01684-17. doi:10.1128/AAC.01684-17
- Matzke GR, Kovarik JM, Rybak MJ, Boike SC. Evaluation of the vancomycin-clearance: creatinine-clearance relationship for predicting vancomycin dosage. Clin Pharm. 1985;4(3):311-315.
- Crass RL, Dunn R, Hong J, Krop LC, Pai MP. Dosing vancomycin in the super obese: less is more. J Antimicrob Chemother. 2018;73(11):3081-3086. doi:10.1093/jac/dky310
- Lodise TP, Rosenkranz SL, Finnemeyer M, et al. The emperor’s new clothes: prospective observational evaluation of the association between initial vancomycIn exposure and failure rates among adult hospitalized patients with methicillin-resistant staphylococcus aureus bloodstream infections (PROVIDE). Clin Infect Dis. 2020;70(8):1536-1545. doi:10.1093/cid/ciz460
Implementation of a Prior Authorization Drug Review Process for Care in the Community Oncology Prescriptions
Background
Veterans receiving care in the community (CITC) are prescribed oral oncology medications to be filled at VA pharmacies. Many of the outpatient prescriptions written for oncology medications require a prior authorization review by a pharmacist. A standardized workflow to obtain outside records to ensure patient safety, appropriate therapeutic selections, and maximize cost avoidance was established in March 2023. This quality improvement project evaluated the implementation of a clinical peer-to-peer prescription referral process between operational and oncology clinical pharmacists (CPS) to include a prior authorization drug request (PADR) review.
Methods
A retrospective chart review was completed to assess the effectiveness of the CITC Rx review process. Patients who had a CITC PADR consult entered between April 2023 and March 2024 were included. Metrics obtained included medication ordered, diagnosis, line of treatment, date prescription received, time to PADR completion, PADR outcome, FDA approval status, and conformity to VA National Oncology Program (NOP) disease pathway. Descriptive statistics were used to describe the data.
Results
Top reasons for referral for CITC included best medical interest and drive time. Fifty-one PADR requests were submitted for 41 patients. Forty-six PADR consults were completed. Approval rate was 85%. Consults involved 32 different oncolytics, 78% had VA Pharmacy Benefits Manager criteria for use. Thirty-seven percent of the PADR requests adhered to the NOP pathways. Approximately 30% of PADR requests did not have an associated NOP pathway. Seventy-four percent of drugs had an associated FDA approval. On average, two calls were made to CITC provider by the operational pharmacist to obtain necessary information for clinical review, resulting in a 5 day time to PADR entry. The average time to PADR consult completion was 9.5 hours. Four interventions addressed drug interactions or dosing adjustments.
Conclusions
This review demonstrated the feasibility and framework for implementing a standardized peer-to-peer PADR consult review process for CITC prescriptions requiring prior authorization. Having separate intake of CITC prescriptions by the operational pharmacist who is responsible for obtaining outside records, the CPS provided a timely clinical review of PADR consults, assuring appropriate therapeutic selections to maximize cost avoidance while maintaining patient safety.
Background
Veterans receiving care in the community (CITC) are prescribed oral oncology medications to be filled at VA pharmacies. Many of the outpatient prescriptions written for oncology medications require a prior authorization review by a pharmacist. A standardized workflow to obtain outside records to ensure patient safety, appropriate therapeutic selections, and maximize cost avoidance was established in March 2023. This quality improvement project evaluated the implementation of a clinical peer-to-peer prescription referral process between operational and oncology clinical pharmacists (CPS) to include a prior authorization drug request (PADR) review.
Methods
A retrospective chart review was completed to assess the effectiveness of the CITC Rx review process. Patients who had a CITC PADR consult entered between April 2023 and March 2024 were included. Metrics obtained included medication ordered, diagnosis, line of treatment, date prescription received, time to PADR completion, PADR outcome, FDA approval status, and conformity to VA National Oncology Program (NOP) disease pathway. Descriptive statistics were used to describe the data.
Results
Top reasons for referral for CITC included best medical interest and drive time. Fifty-one PADR requests were submitted for 41 patients. Forty-six PADR consults were completed. Approval rate was 85%. Consults involved 32 different oncolytics, 78% had VA Pharmacy Benefits Manager criteria for use. Thirty-seven percent of the PADR requests adhered to the NOP pathways. Approximately 30% of PADR requests did not have an associated NOP pathway. Seventy-four percent of drugs had an associated FDA approval. On average, two calls were made to CITC provider by the operational pharmacist to obtain necessary information for clinical review, resulting in a 5 day time to PADR entry. The average time to PADR consult completion was 9.5 hours. Four interventions addressed drug interactions or dosing adjustments.
Conclusions
This review demonstrated the feasibility and framework for implementing a standardized peer-to-peer PADR consult review process for CITC prescriptions requiring prior authorization. Having separate intake of CITC prescriptions by the operational pharmacist who is responsible for obtaining outside records, the CPS provided a timely clinical review of PADR consults, assuring appropriate therapeutic selections to maximize cost avoidance while maintaining patient safety.
Background
Veterans receiving care in the community (CITC) are prescribed oral oncology medications to be filled at VA pharmacies. Many of the outpatient prescriptions written for oncology medications require a prior authorization review by a pharmacist. A standardized workflow to obtain outside records to ensure patient safety, appropriate therapeutic selections, and maximize cost avoidance was established in March 2023. This quality improvement project evaluated the implementation of a clinical peer-to-peer prescription referral process between operational and oncology clinical pharmacists (CPS) to include a prior authorization drug request (PADR) review.
Methods
A retrospective chart review was completed to assess the effectiveness of the CITC Rx review process. Patients who had a CITC PADR consult entered between April 2023 and March 2024 were included. Metrics obtained included medication ordered, diagnosis, line of treatment, date prescription received, time to PADR completion, PADR outcome, FDA approval status, and conformity to VA National Oncology Program (NOP) disease pathway. Descriptive statistics were used to describe the data.
Results
Top reasons for referral for CITC included best medical interest and drive time. Fifty-one PADR requests were submitted for 41 patients. Forty-six PADR consults were completed. Approval rate was 85%. Consults involved 32 different oncolytics, 78% had VA Pharmacy Benefits Manager criteria for use. Thirty-seven percent of the PADR requests adhered to the NOP pathways. Approximately 30% of PADR requests did not have an associated NOP pathway. Seventy-four percent of drugs had an associated FDA approval. On average, two calls were made to CITC provider by the operational pharmacist to obtain necessary information for clinical review, resulting in a 5 day time to PADR entry. The average time to PADR consult completion was 9.5 hours. Four interventions addressed drug interactions or dosing adjustments.
Conclusions
This review demonstrated the feasibility and framework for implementing a standardized peer-to-peer PADR consult review process for CITC prescriptions requiring prior authorization. Having separate intake of CITC prescriptions by the operational pharmacist who is responsible for obtaining outside records, the CPS provided a timely clinical review of PADR consults, assuring appropriate therapeutic selections to maximize cost avoidance while maintaining patient safety.
The OCTAGON Project: A Novel VA-Based Telehealth Intervention for Oral Chemotherapy Monitoring
Background
Many Veterans with cancer experience substantial side effects related to their chemotherapy treatments resulting in impaired quality of life. Prompt management of such symptoms can improve adherence to therapy and potentially clinical outcomes. Previous studies in cancer patients have shown that mobile apps can improve symptom management and quality of life, though there are limited studies using oncology-focused apps in the VA population. The VA Annie App is an optimal platform for Veterans since it relies primarily on SMS-based texting and not on internet capabilities. This would address several well-known barriers to Veterans’ care access (limited internet connectivity, transportation) and enhance symptom reporting between infrequent provider visits. Providers can securely collect app responses within the VA system and there is already considerable VA developer experience with designing complex protocols. The OCTAGON project (Optimizing Cancer Care with Telehealth Assessment for Goal-Oriented Needs) will have the following goals: 1) To develop Annie App protocols to assist in management of cancer and/or chemotherapy-related symptoms (OCTAGON intervention), 2) To examine initial acceptability, feasibility, and Veteran-reported outcomes, 3) To explore short term effects on the utilization of VA encounters.
Methods
All patients who are primarily being managed at the VA Ann Arbor for their cancer therapy and are receiving one of the following therapies are considered eligible: EGFR inhibitors (lung cancer), antiandrogen therapies (prostate cancer), BTK inhibitors (lymphoma).
Discussion
Drug-specific protocols will be developed in conjunction with clinical pharmacists with experience in outpatient oral chemotherapy toxicity monitoring. Questions will have either a Yes/No, or numerical response. Interventions will be administered weekly for the first 3 months after enrollment, then decrease to monthly for a total of 6 months on protocol. Patients will be directed to contact their providers with any significant changes in tolerability. Planned data collected will include intervention question responses, adverse events, demographics, diagnosis, disease response, hospitalizations, treatment dose reductions or interruptions, provider and staff utilization. Survey responses to assess treatment acceptability (Treatment Acceptability/Adherence Scale), usability (System Usability Scale), general health (PROMIS-GH), and patient satisfaction will also be collected. Funding: VA Telehealth Research and Innovation for Veterans with Cancer (THRIVE).
Background
Many Veterans with cancer experience substantial side effects related to their chemotherapy treatments resulting in impaired quality of life. Prompt management of such symptoms can improve adherence to therapy and potentially clinical outcomes. Previous studies in cancer patients have shown that mobile apps can improve symptom management and quality of life, though there are limited studies using oncology-focused apps in the VA population. The VA Annie App is an optimal platform for Veterans since it relies primarily on SMS-based texting and not on internet capabilities. This would address several well-known barriers to Veterans’ care access (limited internet connectivity, transportation) and enhance symptom reporting between infrequent provider visits. Providers can securely collect app responses within the VA system and there is already considerable VA developer experience with designing complex protocols. The OCTAGON project (Optimizing Cancer Care with Telehealth Assessment for Goal-Oriented Needs) will have the following goals: 1) To develop Annie App protocols to assist in management of cancer and/or chemotherapy-related symptoms (OCTAGON intervention), 2) To examine initial acceptability, feasibility, and Veteran-reported outcomes, 3) To explore short term effects on the utilization of VA encounters.
Methods
All patients who are primarily being managed at the VA Ann Arbor for their cancer therapy and are receiving one of the following therapies are considered eligible: EGFR inhibitors (lung cancer), antiandrogen therapies (prostate cancer), BTK inhibitors (lymphoma).
Discussion
Drug-specific protocols will be developed in conjunction with clinical pharmacists with experience in outpatient oral chemotherapy toxicity monitoring. Questions will have either a Yes/No, or numerical response. Interventions will be administered weekly for the first 3 months after enrollment, then decrease to monthly for a total of 6 months on protocol. Patients will be directed to contact their providers with any significant changes in tolerability. Planned data collected will include intervention question responses, adverse events, demographics, diagnosis, disease response, hospitalizations, treatment dose reductions or interruptions, provider and staff utilization. Survey responses to assess treatment acceptability (Treatment Acceptability/Adherence Scale), usability (System Usability Scale), general health (PROMIS-GH), and patient satisfaction will also be collected. Funding: VA Telehealth Research and Innovation for Veterans with Cancer (THRIVE).
Background
Many Veterans with cancer experience substantial side effects related to their chemotherapy treatments resulting in impaired quality of life. Prompt management of such symptoms can improve adherence to therapy and potentially clinical outcomes. Previous studies in cancer patients have shown that mobile apps can improve symptom management and quality of life, though there are limited studies using oncology-focused apps in the VA population. The VA Annie App is an optimal platform for Veterans since it relies primarily on SMS-based texting and not on internet capabilities. This would address several well-known barriers to Veterans’ care access (limited internet connectivity, transportation) and enhance symptom reporting between infrequent provider visits. Providers can securely collect app responses within the VA system and there is already considerable VA developer experience with designing complex protocols. The OCTAGON project (Optimizing Cancer Care with Telehealth Assessment for Goal-Oriented Needs) will have the following goals: 1) To develop Annie App protocols to assist in management of cancer and/or chemotherapy-related symptoms (OCTAGON intervention), 2) To examine initial acceptability, feasibility, and Veteran-reported outcomes, 3) To explore short term effects on the utilization of VA encounters.
Methods
All patients who are primarily being managed at the VA Ann Arbor for their cancer therapy and are receiving one of the following therapies are considered eligible: EGFR inhibitors (lung cancer), antiandrogen therapies (prostate cancer), BTK inhibitors (lymphoma).
Discussion
Drug-specific protocols will be developed in conjunction with clinical pharmacists with experience in outpatient oral chemotherapy toxicity monitoring. Questions will have either a Yes/No, or numerical response. Interventions will be administered weekly for the first 3 months after enrollment, then decrease to monthly for a total of 6 months on protocol. Patients will be directed to contact their providers with any significant changes in tolerability. Planned data collected will include intervention question responses, adverse events, demographics, diagnosis, disease response, hospitalizations, treatment dose reductions or interruptions, provider and staff utilization. Survey responses to assess treatment acceptability (Treatment Acceptability/Adherence Scale), usability (System Usability Scale), general health (PROMIS-GH), and patient satisfaction will also be collected. Funding: VA Telehealth Research and Innovation for Veterans with Cancer (THRIVE).
How to Make Keeping Up With the Drugs as Easy as Keeping Up With the Kardashians: Implementing a Local Oncology Drug Review Committee
Background
From 2000-2022 there were over 200 new drug and over 500 indication approvals specific to oncology. The rate of approvals has increased exponentially, making it difficult to maintain an up-to-date, standardized practice. Nationally, Veterans Affairs (VA) formulary decisions can take time given a lengthy approval process. Locally, the need was identified to incorporate new drugs and data into practice more rapidly. When bringing requests to the facility Pharmacy and Therapeutics (P&T) Committee, it was recognized that the membership consisting of non-oncology practitioners did not allow for meaningful discussion of utilization. In 2017, a dedicated oncology drug review committee (DRC) comprised of oncology practitioners and a facility formulary representative was created as a P&T workgroup. Purpose: Evaluate and describe the utility of forming a local oncology DRC to incorporate new drugs and data into practice.
Methods
DRC minutes from December 2017 to May 2023 were reviewed. Discussion items were categorized into type of review. Date of local review was compared to national formulary criteria for use publication dates, and date of FDA approval for new drugs or publication date for new data, where applicable. Items were excluded if crucial information was missing from minutes. Descriptive statistics were used.
Results
Over 65 months, 38 meetings were held. Thirty total members include: pharmacists, physicians, fellows, and advanced practice providers. Items reviewed included: 36 new drugs (ND), 36 new indications/data (NI), 14 institutional preferences, 10 new dosage form/biosimilars, 4 drug shortages and 2 others. The median time from ND approval to discussion was 3 months (n= 36, IQR 3-6) and NI from publication was 3 months (n=30, IQR 1-8). Nearly all (34/36, 94%) ND were reviewed prior to national review. Local review was a median of 7 months before national, with 11 drugs currently having no published national criteria for use (n=25, IQR 2-12).
Conclusions
DRC formation has enabled faster incorporation of new drugs/indications into practice. It has also created an appropriate forum for in-depth utilization discussions, pharmacoeconomic stewardship, and sharing of formulary and medication related information. VA Health Systems could consider implementing similar committees to review and implement up-to-date oncology practices.
Background
From 2000-2022 there were over 200 new drug and over 500 indication approvals specific to oncology. The rate of approvals has increased exponentially, making it difficult to maintain an up-to-date, standardized practice. Nationally, Veterans Affairs (VA) formulary decisions can take time given a lengthy approval process. Locally, the need was identified to incorporate new drugs and data into practice more rapidly. When bringing requests to the facility Pharmacy and Therapeutics (P&T) Committee, it was recognized that the membership consisting of non-oncology practitioners did not allow for meaningful discussion of utilization. In 2017, a dedicated oncology drug review committee (DRC) comprised of oncology practitioners and a facility formulary representative was created as a P&T workgroup. Purpose: Evaluate and describe the utility of forming a local oncology DRC to incorporate new drugs and data into practice.
Methods
DRC minutes from December 2017 to May 2023 were reviewed. Discussion items were categorized into type of review. Date of local review was compared to national formulary criteria for use publication dates, and date of FDA approval for new drugs or publication date for new data, where applicable. Items were excluded if crucial information was missing from minutes. Descriptive statistics were used.
Results
Over 65 months, 38 meetings were held. Thirty total members include: pharmacists, physicians, fellows, and advanced practice providers. Items reviewed included: 36 new drugs (ND), 36 new indications/data (NI), 14 institutional preferences, 10 new dosage form/biosimilars, 4 drug shortages and 2 others. The median time from ND approval to discussion was 3 months (n= 36, IQR 3-6) and NI from publication was 3 months (n=30, IQR 1-8). Nearly all (34/36, 94%) ND were reviewed prior to national review. Local review was a median of 7 months before national, with 11 drugs currently having no published national criteria for use (n=25, IQR 2-12).
Conclusions
DRC formation has enabled faster incorporation of new drugs/indications into practice. It has also created an appropriate forum for in-depth utilization discussions, pharmacoeconomic stewardship, and sharing of formulary and medication related information. VA Health Systems could consider implementing similar committees to review and implement up-to-date oncology practices.
Background
From 2000-2022 there were over 200 new drug and over 500 indication approvals specific to oncology. The rate of approvals has increased exponentially, making it difficult to maintain an up-to-date, standardized practice. Nationally, Veterans Affairs (VA) formulary decisions can take time given a lengthy approval process. Locally, the need was identified to incorporate new drugs and data into practice more rapidly. When bringing requests to the facility Pharmacy and Therapeutics (P&T) Committee, it was recognized that the membership consisting of non-oncology practitioners did not allow for meaningful discussion of utilization. In 2017, a dedicated oncology drug review committee (DRC) comprised of oncology practitioners and a facility formulary representative was created as a P&T workgroup. Purpose: Evaluate and describe the utility of forming a local oncology DRC to incorporate new drugs and data into practice.
Methods
DRC minutes from December 2017 to May 2023 were reviewed. Discussion items were categorized into type of review. Date of local review was compared to national formulary criteria for use publication dates, and date of FDA approval for new drugs or publication date for new data, where applicable. Items were excluded if crucial information was missing from minutes. Descriptive statistics were used.
Results
Over 65 months, 38 meetings were held. Thirty total members include: pharmacists, physicians, fellows, and advanced practice providers. Items reviewed included: 36 new drugs (ND), 36 new indications/data (NI), 14 institutional preferences, 10 new dosage form/biosimilars, 4 drug shortages and 2 others. The median time from ND approval to discussion was 3 months (n= 36, IQR 3-6) and NI from publication was 3 months (n=30, IQR 1-8). Nearly all (34/36, 94%) ND were reviewed prior to national review. Local review was a median of 7 months before national, with 11 drugs currently having no published national criteria for use (n=25, IQR 2-12).
Conclusions
DRC formation has enabled faster incorporation of new drugs/indications into practice. It has also created an appropriate forum for in-depth utilization discussions, pharmacoeconomic stewardship, and sharing of formulary and medication related information. VA Health Systems could consider implementing similar committees to review and implement up-to-date oncology practices.
PHASER Testing Initiative for Patients Newly Diagnosed With a GI Malignancy
Background
In December of 2023, the Survivorship Coordinator at VA Connecticut spearheaded a multidisciplinary collaboration to offer PHASER testing to all patients newly diagnosed with a GI malignancy and/ or patients with a known GI malignancy and a new recurrence that might necessitate chemotherapy. The PHASER panel includes two genes that are involved in the metabolism of two commonly used chemotherapy drugs in this patient population.
Methods
By identifying patients who may have impaired metabolism prior to starting treatment, the doses of the appropriate drugs, 5FU and irinotecan, can be adjusted if appropriate, leading to less toxicity for patients while on treatment and fewer lingering side-effects from treatment. We are tracking all of the patients who are being tested and will report quarterly to the Cancer Committee on any findings with a specific focus on whether any dose-adjustments were made to Veteran’s chemotherapy regimens as the result of this testing.
Discussion
We have developed a systematic process centered around GI tumor boards to ensure that testing is done at least two weeks prior to planned chemotherapy start-date to ensure adequate time for testing results to be received. We have developed a systematic process whereby primary care providers and pharmacists are alerted to the PHASER results and patients’ non-oncology medications are reviewed for any recommended adjustments. We will have 9 months of data to report on at AVAHO as well as lessons learned from this new quality improvement process. Despite access to pharmacogenomic testing at VA, there can be variations between VA sites in terms of uptake of this new testing. VA Connecticut’s PHASER testing initiative for patients with GI malignancies is a model that can be replicated throughout the VA. This initiative is part of a broader focus at VA Connecticut on “pre-habilitation” and pre-treatment testing that is designed to reduce toxicity of treatment and improve quality of life for cancer survivors.
Background
In December of 2023, the Survivorship Coordinator at VA Connecticut spearheaded a multidisciplinary collaboration to offer PHASER testing to all patients newly diagnosed with a GI malignancy and/ or patients with a known GI malignancy and a new recurrence that might necessitate chemotherapy. The PHASER panel includes two genes that are involved in the metabolism of two commonly used chemotherapy drugs in this patient population.
Methods
By identifying patients who may have impaired metabolism prior to starting treatment, the doses of the appropriate drugs, 5FU and irinotecan, can be adjusted if appropriate, leading to less toxicity for patients while on treatment and fewer lingering side-effects from treatment. We are tracking all of the patients who are being tested and will report quarterly to the Cancer Committee on any findings with a specific focus on whether any dose-adjustments were made to Veteran’s chemotherapy regimens as the result of this testing.
Discussion
We have developed a systematic process centered around GI tumor boards to ensure that testing is done at least two weeks prior to planned chemotherapy start-date to ensure adequate time for testing results to be received. We have developed a systematic process whereby primary care providers and pharmacists are alerted to the PHASER results and patients’ non-oncology medications are reviewed for any recommended adjustments. We will have 9 months of data to report on at AVAHO as well as lessons learned from this new quality improvement process. Despite access to pharmacogenomic testing at VA, there can be variations between VA sites in terms of uptake of this new testing. VA Connecticut’s PHASER testing initiative for patients with GI malignancies is a model that can be replicated throughout the VA. This initiative is part of a broader focus at VA Connecticut on “pre-habilitation” and pre-treatment testing that is designed to reduce toxicity of treatment and improve quality of life for cancer survivors.
Background
In December of 2023, the Survivorship Coordinator at VA Connecticut spearheaded a multidisciplinary collaboration to offer PHASER testing to all patients newly diagnosed with a GI malignancy and/ or patients with a known GI malignancy and a new recurrence that might necessitate chemotherapy. The PHASER panel includes two genes that are involved in the metabolism of two commonly used chemotherapy drugs in this patient population.
Methods
By identifying patients who may have impaired metabolism prior to starting treatment, the doses of the appropriate drugs, 5FU and irinotecan, can be adjusted if appropriate, leading to less toxicity for patients while on treatment and fewer lingering side-effects from treatment. We are tracking all of the patients who are being tested and will report quarterly to the Cancer Committee on any findings with a specific focus on whether any dose-adjustments were made to Veteran’s chemotherapy regimens as the result of this testing.
Discussion
We have developed a systematic process centered around GI tumor boards to ensure that testing is done at least two weeks prior to planned chemotherapy start-date to ensure adequate time for testing results to be received. We have developed a systematic process whereby primary care providers and pharmacists are alerted to the PHASER results and patients’ non-oncology medications are reviewed for any recommended adjustments. We will have 9 months of data to report on at AVAHO as well as lessons learned from this new quality improvement process. Despite access to pharmacogenomic testing at VA, there can be variations between VA sites in terms of uptake of this new testing. VA Connecticut’s PHASER testing initiative for patients with GI malignancies is a model that can be replicated throughout the VA. This initiative is part of a broader focus at VA Connecticut on “pre-habilitation” and pre-treatment testing that is designed to reduce toxicity of treatment and improve quality of life for cancer survivors.
Barriers from Detection to Treatment in Lung Cancer: A Single Veteran Affair Institution Review
Background
Lung cancer is the leading cause of cancer related deaths in the United States. The impact of treatment delay proves difficult to quantify, but increased time to treatment and subsequent progression can limit a patient’s chance for curative intent therapy. Reducing time to treatment aims to improve patient outcome and experience. This study aims to identify the median timeframes that occur in the diagnosis and treatment of lung cancer patients within a single Veteran Affair (VA) Medical Center.
Methods
A retrospective chart review was conducted on 123 new primary lung cancer cases detected by imaging between January 1, 2019 and December 31, 2022 within a single VA medical center. Exclusions were preexisting lung cancer or other malignancy. The following data was collected: time to PET scan, referrals, and treatment initiation. KruskalWallis test and Mann-Whitney U test was employed to assess differences in treatment times based on treatment modality and disease stage, respectively
Results
The median time from first abnormal image to PET scan was 26 days. The median time from initial abnormal scan to treatment was 91 days. Treatment initiation was significantly shorter in late-state disease (IV, extensive stage) at 57 days compared to early-stage disease (I-III, limited stage) at 98.5 days (p= 0.00008). There was a difference in the median time from abnormal scan to treatment initiation based on treatment modality: chemotherapy, radiation therapy, and surgical intervention occurred at 60 days, 86 days, and 98 days, respectively (p= 0.005).
Conclusions
At our institution, patients with latestage lung cancer initiate therapy significantly faster than those diagnosed with early-stage cancer. We feel this is largely due to complex, multidisciplinary coordination of early-stage disease, in contrast to those diagnosed at later stage disease who are treated in a palliative, systemic fashion. This study was instrumental at identifying key areas along the process that can be improved upon. Based on this data, changes will be implemented and studied in effort to shorten time to treatment.
Background
Lung cancer is the leading cause of cancer related deaths in the United States. The impact of treatment delay proves difficult to quantify, but increased time to treatment and subsequent progression can limit a patient’s chance for curative intent therapy. Reducing time to treatment aims to improve patient outcome and experience. This study aims to identify the median timeframes that occur in the diagnosis and treatment of lung cancer patients within a single Veteran Affair (VA) Medical Center.
Methods
A retrospective chart review was conducted on 123 new primary lung cancer cases detected by imaging between January 1, 2019 and December 31, 2022 within a single VA medical center. Exclusions were preexisting lung cancer or other malignancy. The following data was collected: time to PET scan, referrals, and treatment initiation. KruskalWallis test and Mann-Whitney U test was employed to assess differences in treatment times based on treatment modality and disease stage, respectively
Results
The median time from first abnormal image to PET scan was 26 days. The median time from initial abnormal scan to treatment was 91 days. Treatment initiation was significantly shorter in late-state disease (IV, extensive stage) at 57 days compared to early-stage disease (I-III, limited stage) at 98.5 days (p= 0.00008). There was a difference in the median time from abnormal scan to treatment initiation based on treatment modality: chemotherapy, radiation therapy, and surgical intervention occurred at 60 days, 86 days, and 98 days, respectively (p= 0.005).
Conclusions
At our institution, patients with latestage lung cancer initiate therapy significantly faster than those diagnosed with early-stage cancer. We feel this is largely due to complex, multidisciplinary coordination of early-stage disease, in contrast to those diagnosed at later stage disease who are treated in a palliative, systemic fashion. This study was instrumental at identifying key areas along the process that can be improved upon. Based on this data, changes will be implemented and studied in effort to shorten time to treatment.
Background
Lung cancer is the leading cause of cancer related deaths in the United States. The impact of treatment delay proves difficult to quantify, but increased time to treatment and subsequent progression can limit a patient’s chance for curative intent therapy. Reducing time to treatment aims to improve patient outcome and experience. This study aims to identify the median timeframes that occur in the diagnosis and treatment of lung cancer patients within a single Veteran Affair (VA) Medical Center.
Methods
A retrospective chart review was conducted on 123 new primary lung cancer cases detected by imaging between January 1, 2019 and December 31, 2022 within a single VA medical center. Exclusions were preexisting lung cancer or other malignancy. The following data was collected: time to PET scan, referrals, and treatment initiation. KruskalWallis test and Mann-Whitney U test was employed to assess differences in treatment times based on treatment modality and disease stage, respectively
Results
The median time from first abnormal image to PET scan was 26 days. The median time from initial abnormal scan to treatment was 91 days. Treatment initiation was significantly shorter in late-state disease (IV, extensive stage) at 57 days compared to early-stage disease (I-III, limited stage) at 98.5 days (p= 0.00008). There was a difference in the median time from abnormal scan to treatment initiation based on treatment modality: chemotherapy, radiation therapy, and surgical intervention occurred at 60 days, 86 days, and 98 days, respectively (p= 0.005).
Conclusions
At our institution, patients with latestage lung cancer initiate therapy significantly faster than those diagnosed with early-stage cancer. We feel this is largely due to complex, multidisciplinary coordination of early-stage disease, in contrast to those diagnosed at later stage disease who are treated in a palliative, systemic fashion. This study was instrumental at identifying key areas along the process that can be improved upon. Based on this data, changes will be implemented and studied in effort to shorten time to treatment.
Anchors Aweigh, Clinical Trial Navigation at the VA!
Background
Despite the benefit of cancer clinical trials (CTs) in increasing medical knowledge and broadening treatment options, VA oncologists face challenges referring or enrolling Veterans in CTs including identifying appropriate CTs and navigating the referral process especially for non-VA CTs. To address these challenges, the VA National Oncology Program (NOP) provided guidance regarding community care referral for CT participation and established the Cancer Clinical Trial Nurse Navigation (CTN) service.
Methods
Referrals to CTN occur via Precision Oncology consult or email to CancerClinicalTrialsNavigation@va.gov. The CT nurse navigator educates Veterans about CTs, identifies CTs for Veterans based on disease and geographic area, provides written summaries to Veterans and VA oncologists, and facilitates communication between clinical and research teams. Descriptive statistics were used to summarize characteristics of Veterans referred to CTN and results of the CTN searches. A semi-structured survey was used to assess satisfaction from 50 VA oncologists who had used the CTN service.
Results
Between June 2023 and May 2024, 72 Veterans were referred to CTN. Patient characteristics include male (94%), non-rural (65%), median age 66.5 (range 27-80), self-reported race as White (74%) and Black (22%), cancer type as solid tumor (73%) and blood cancer (27%). The median number of CTs found for each Veteran was two (range 0 - 12). No referred Veterans enrolled in CTs, with the most common causes being CT ineligibility and desire to receive standard therapy in the VA. Twenty oncologists were educated about NOP CT guidance. The response rate to the feedback survey was modest (34%) but 94% of survey respondents rated their overall satisfaction as highly satisfied or satisfied.
Conclusions
The CTN assists Veterans and VA oncologists in connecting with CTs. The high satisfaction rate and ability to reach a racially and geographically diverse Veteran population are measures of early program success. By lowering the barriers for VA oncologists to consider CTs for their patients, the CTN expects increased and earlier referrals of Veterans, which may improve CT eligibility and participation. Future efforts to provide disease-directed education about CTs to Veterans and VA oncologists is intended to encourage early consideration of CTs.
Background
Despite the benefit of cancer clinical trials (CTs) in increasing medical knowledge and broadening treatment options, VA oncologists face challenges referring or enrolling Veterans in CTs including identifying appropriate CTs and navigating the referral process especially for non-VA CTs. To address these challenges, the VA National Oncology Program (NOP) provided guidance regarding community care referral for CT participation and established the Cancer Clinical Trial Nurse Navigation (CTN) service.
Methods
Referrals to CTN occur via Precision Oncology consult or email to CancerClinicalTrialsNavigation@va.gov. The CT nurse navigator educates Veterans about CTs, identifies CTs for Veterans based on disease and geographic area, provides written summaries to Veterans and VA oncologists, and facilitates communication between clinical and research teams. Descriptive statistics were used to summarize characteristics of Veterans referred to CTN and results of the CTN searches. A semi-structured survey was used to assess satisfaction from 50 VA oncologists who had used the CTN service.
Results
Between June 2023 and May 2024, 72 Veterans were referred to CTN. Patient characteristics include male (94%), non-rural (65%), median age 66.5 (range 27-80), self-reported race as White (74%) and Black (22%), cancer type as solid tumor (73%) and blood cancer (27%). The median number of CTs found for each Veteran was two (range 0 - 12). No referred Veterans enrolled in CTs, with the most common causes being CT ineligibility and desire to receive standard therapy in the VA. Twenty oncologists were educated about NOP CT guidance. The response rate to the feedback survey was modest (34%) but 94% of survey respondents rated their overall satisfaction as highly satisfied or satisfied.
Conclusions
The CTN assists Veterans and VA oncologists in connecting with CTs. The high satisfaction rate and ability to reach a racially and geographically diverse Veteran population are measures of early program success. By lowering the barriers for VA oncologists to consider CTs for their patients, the CTN expects increased and earlier referrals of Veterans, which may improve CT eligibility and participation. Future efforts to provide disease-directed education about CTs to Veterans and VA oncologists is intended to encourage early consideration of CTs.
Background
Despite the benefit of cancer clinical trials (CTs) in increasing medical knowledge and broadening treatment options, VA oncologists face challenges referring or enrolling Veterans in CTs including identifying appropriate CTs and navigating the referral process especially for non-VA CTs. To address these challenges, the VA National Oncology Program (NOP) provided guidance regarding community care referral for CT participation and established the Cancer Clinical Trial Nurse Navigation (CTN) service.
Methods
Referrals to CTN occur via Precision Oncology consult or email to CancerClinicalTrialsNavigation@va.gov. The CT nurse navigator educates Veterans about CTs, identifies CTs for Veterans based on disease and geographic area, provides written summaries to Veterans and VA oncologists, and facilitates communication between clinical and research teams. Descriptive statistics were used to summarize characteristics of Veterans referred to CTN and results of the CTN searches. A semi-structured survey was used to assess satisfaction from 50 VA oncologists who had used the CTN service.
Results
Between June 2023 and May 2024, 72 Veterans were referred to CTN. Patient characteristics include male (94%), non-rural (65%), median age 66.5 (range 27-80), self-reported race as White (74%) and Black (22%), cancer type as solid tumor (73%) and blood cancer (27%). The median number of CTs found for each Veteran was two (range 0 - 12). No referred Veterans enrolled in CTs, with the most common causes being CT ineligibility and desire to receive standard therapy in the VA. Twenty oncologists were educated about NOP CT guidance. The response rate to the feedback survey was modest (34%) but 94% of survey respondents rated their overall satisfaction as highly satisfied or satisfied.
Conclusions
The CTN assists Veterans and VA oncologists in connecting with CTs. The high satisfaction rate and ability to reach a racially and geographically diverse Veteran population are measures of early program success. By lowering the barriers for VA oncologists to consider CTs for their patients, the CTN expects increased and earlier referrals of Veterans, which may improve CT eligibility and participation. Future efforts to provide disease-directed education about CTs to Veterans and VA oncologists is intended to encourage early consideration of CTs.