Implementing an Organized Colorectal Cancer Screening Program: Lessons Learned From an Academic-Community Practice.

Introduction: The effectiveness of mailed fecal immunochemical test outreach might be enhanced through an organized colorectal cancer screening program, yet published real-world experiences are limited. We synthesized the process of implementing a colorectal cancer screening program that used mailed fecal immunochemical test outreach in a large integrated academic-community practice. Methods: Data from a pilot mailed fecal immunochemical test program were shared with healthcare system leadership, which inspired the creation of a cross-institutional organized colorectal cancer screening program. In partnership with a centralized population health team and primary care, we defined (1) the institutional approach to colorectal cancer screening, (2) the target population and method for screening, (3) the team responsible for implementation, (4) the healthcare team responsible for decisions and care, (5) a quality assurance structure, and (6) a method for identifying cancer occurrence. Results: The Fred Hutch/UW Medicine Population Health Colorectal Cancer Screening Program began in September 2021. The workflow for mailed fecal immunochemical test outreach included a mailed postcard, a MyChart message from the patient's primary care provider, a fecal immunochemical test kit with a letter signed by the primary care provider and program director, and up to 3 biweekly reminders. Patients without a colonoscopy 3 months after an abnormal fecal immunochemical test result received navigation through the program. In the first program year, we identified 9,719 patients eligible for outreach, and in an intention-to-treat analysis, 32% of patients completed colorectal cancer screening by fecal immunochemical test or colonoscopy. Conclusions: Real-world experiences detailing how to implement organized colorectal cancer screening programs might increase adoption. In our experience, broadly disseminating pilot data, early institutional support, robust data management, and strong cross-departmental relationships were critical to successfully implementing a colorectal cancer screening program that benefits all patients.

A proactive financial navigation intervention in patients with newly diagnosed gastric and gastroesophageal junction adenocarcinoma.

PURPOSE: Many cancer patients and caregivers experience financial hardship, leading to poor outcomes. Gastric and gastroesophageal junction (GEJ) cancer patients are particularly at risk for financial hardship given the intensity of treatment. This pilot randomized study among gastric/GEJ cancer patients and caregivers tested a proactive financial navigation (FN) intervention to obtain a signal of efficacy to inform a larger, more rigorous randomized study. METHODS: We tested a 3-month proactive FN intervention among gastric/GEJ cancer patients and caregivers compared to usual care. Caregiver participation was optional. The primary endpoint was incidence of financial hardship, defined as follows: accrual of debt, income decline of ≥ 20%, or taking loans to pay for treatment. Data from participant surveys and documentation by partner organizations delivering the FN intervention was analyzed and outcomes were compared between study arms. RESULTS: Nineteen patients and 12 caregivers consented. Primary FN resources provided included insurance navigation, budget planning, and help with out-of-pocket medical expenses. Usual care patients were more likely to experience financial hardship (50% vs 40%) and declines in quality of life (37.5% vs 0%) compared to intervention patients. Caregivers in both arms reported increased financial stress and poorer quality of life over the study period. CONCLUSIONS: Proactive financial navigation has potentially positive impacts on financial hardship and quality of life for cancer patients and more large-scale randomized interventions should be conducted to rigorously explore the impact of similar interventions. Interventions that have the potential to lessen caregiver financial stress and burden need further exploration. TRIAL REGISTRATION: TRN: NCT03986502, June 14, 2019.

Performance of OC-Auto Micro 80 Fecal Immunochemical Test in an Integrated Academic-Community Health System.

GOALS: We aimed to determine the performance of the OC-Auto Micro 80 fecal immunochemical test (FIT) in an average-risk population receiving care in an integrated, academic-community health system. BACKGROUND: The FIT is the most used colorectal cancer (CRC) screening test worldwide. However, many Food and Drug Administration-cleared FIT products have not been evaluated in clinical settings. STUDY: We performed a retrospective cohort study of patients (50 to 75 y old) in the University of Washington Medicine health care system who were screened for CRC by OC-Auto Micro 80 FIT between March 2016 and September 2021. We used electronic health records to extract patient-level and clinic-level factors, FIT use, colonoscopy, and pathology findings. The primary outcomes were the FIT positivity rate and neoplasms detected at colonoscopy. Secondary outcomes were FIT positivity by sex and safety-net versus non-safety-net clinical settings. RESULTS: We identified 39,984 FITs completed by 26,384 patients; 2411 (6.0%) had a positive FIT result (>100 ng/mL of hemoglobin in buffer), and 1246 (51.7%) completed a follow-up colonoscopy. The FIT positive rate was 7.0% in men and 5.2% in women (P <0.01). Among those who completed a colonoscopy after an abnormal FIT result, the positive predictive value for CRC, advanced adenoma, and advanced neoplasia was 3.0%, 20.9%, and 23.9%, respectively. CONCLUSIONS: In a retrospective analysis of a large heterogeneous population, the OC-Auto Micro 80 FIT for CRC screening demonstrated a positivity rate of 6.0% and a positive predictive value for CRC of 3.0%.

Intervention Nonadherence in the TrACER (S1415CD) Study: A Pragmatic Randomized Trial of a Standardized Order Entry for CSF Prescribing.

PURPOSE: We conducted a pragmatic, cluster-randomized trial to test whether a guideline-based standing order entry (SOE) improves use of primary prophylactic CSF (PP-CSF) prescribing for patients receiving myelosuppressive chemotherapy. We investigated variability in adherence to the intervention. METHODS: We conducted a cluster-randomized trial among 32 oncology clinics from the NCI Community Oncology Research Program. Clinics were randomized 3:1 to a guideline-based PP-CSF SOE or usual care. Among SOE sites, automated orders for PP-CSF were included for regimens at high risk for febrile neutropenia (FN) and an alert not to use PP-CSF for low FN risk. A secondary 1:1 randomization was done among intervention sites to either SOE to prescribe or an alert to not prescribe PP-CSF for patients receiving intermediate risk-regimens. Providers were allowed to override the SOE. RESULTS: Overall, PP-CSF use among patients receiving high FN risk treatment was high and not different between arms; however, rates of PP-CSF use varied widely by site, ranging from 48.6% to 100%. Among those receiving low FN risk regimens, PP-CSF use was low and not different between arms; however, PP-CSF use ranged from 0% to 19.4% across sites. In the intermediate-risk substudy, PP-CSF was five-fold higher among sites randomized to SOE; however, there was considerable variability in adherence to intervention assignment: PP-CSF use ranged from 0% to 75% among sites randomized to SOE. Despite an alert to not prescribe, PP-CSF prescribing ranged from 0% to 33%. CONCLUSION: In this randomized pragmatic trial aimed at improving PP-CSF prescribing, there was substantial variability in site adherence to the intervention assignment. Although the ability to opt out of the intervention is a feature of pragmatic trials, planning to estimate nonadherence is critical to ensure adequate power.

Health System-Provided Rideshare Is Safe and Addresses Barriers to Colonoscopy Completion.

In 2019, nearly 14 million colonoscopies were performed in the United States.1 In these settings, the accepted practice is that a responsible person drives and chaperones patients home after receiving procedural sedation, including colonoscopy.2 Lack of access to transportation and/or a chaperone is a persistent barrier to care in safety-net health systems and federally qualified health centers as a result of lower incomes, underinsurance, and higher social needs.3 Given racial, ethnic, and socioeconomic disparities in many digestive diseases that require colonoscopy for diagnosis and management, innovative solutions are needed to overcome logistical barriers to colonoscopy completion, especially in these settings.

Assessment of financial screening and navigation capabilities at National Cancer Institute community oncology clinics.

BACKGROUND: Cancer-related financial hardship is a side effect of cancer diagnosis and treatment, and affects both patients and caregivers. Although many oncology clinics have increased financial navigation services, few have resources to proactively provide financial counseling and assistance to families affected by cancer before financial hardship occurs. As part of an ongoing randomized study testing a proactive financial navigation intervention, S1912CD, among sites of the National Cancer Institute Community Oncology Research Program (NCORP), we conducted a baseline survey to learn more about existing financial resources available to patients and caregivers. METHODS: The NCORP sites participating in the S1912CD study completed a required 10-question survey about their available financial resources and an optional 5-question survey that focused on financial screening and navigation workflow and challenges prior to starting recruitment. The proportion of NCORP sites offering financial navigation services was calculated and responses to the optional survey were reviewed to determine current screening and navigation practices and identify any challenges. RESULTS: Most sites (96%) reported offering financial navigation for cancer patients. Sites primarily identified patients needing financial assistance through social work evaluations (78%) or distress screening tools (76%). Sites revealed challenges in addressing financial needs at the outset and through diagnosis, including lack of proactive screening and referral to financial navigation services as well as staffing challenges. CONCLUSIONS: Although most participating NCORP sites offer some form of financial assistance, the survey data enabled identification of gaps and challenges in providing services. Utilizing community partners to deliver comprehensive financial navigation guidance to cancer patients and caregivers may help meet needs while reducing site burden.

Association Between Patient-Level, Clinic-Level, and Geographical-Level Factors and 1-Year Surveillance Colonoscopy Adherence.

INTRODUCTION: Surveillance colonoscopy 1 year after surgical resection for patients with stages I-III colorectal cancer (CRC) is suboptimal, and data on factors associated with lack of adherence are limited. Using surveillance colonoscopy data from Washington state, we aimed to determine the patient, clinic, and geographical factors associated with adherence. METHODS: Using administrative insurance claims linked to Washington cancer registry data, we conducted a retrospective cohort study of adult patients diagnosed with stage I-III CRC between 2011 and 2018 with continuous insurance for at least 18 months after diagnosis. We determined the adherence rate to 1-year surveillance colonoscopy and conducted logistic regression analysis to identify factors associated with completion. RESULTS: Of 4,481 patients with stage I-III CRC identified, 55.8% completed a 1-year surveillance colonoscopy. The median time to colonoscopy completion was 370 days. On multivariate analysis, older age, higher-stage CRC, Medicare insurance or multiple insurance carriers, higher Charlson Comorbidity Index score, and living without a partner were significantly associated with decreased adherence to 1-year surveillance colonoscopy. Among 29 eligible clinics, 51% (n = 15) reported lower-than-expected surveillance colonoscopy rates based on patient mix. DISCUSSION: Surveillance colonoscopy 1 year after surgical resection is suboptimal in Washington state. Patient and clinic factors, but not geographic factors (Area Deprivation Index), were significantly associated with surveillance colonoscopy completion. These data will inform the development of patient-level and clinic-level interventions to address an important quality-of-care issue across Washington.

A Pragmatic Cluster-Randomized Trial of a Standing Order Entry Intervention for Colony-Stimulating Factor Use Among Patients at Intermediate Risk for Febrile Neutropenia.

PURPOSE: Primary prophylactic colony-stimulating factors (PP-CSFs) are prescribed to reduce febrile neutropenia (FN) but their benefit for intermediate FN risk regimens is uncertain. Within a pragmatic, randomized trial of a standing order entry (SOE) PP-CSF intervention, we conducted a substudy to evaluate the effectiveness of SOE for patients receiving intermediate-risk regimens. METHODS: TrACER was a cluster randomized trial where practices were randomized to usual care or a guideline-based SOE intervention. In the primary study, sites were randomized 3:1 to SOE of automated PP-CSF orders for high FN risk regimens and alerts against PP-CSF use for low-risk regimens versus usual care. A secondary 1:1 randomization assigned 24 intervention sites to either SOE to prescribe or an alert to not prescribe PP-CSF for intermediate-risk regimens. Clinicians were allowed to over-ride the SOE. Patients with breast, colorectal, or non-small-cell lung cancer were enrolled. Mixed-effect logistic regression models were used to test differences between randomized sites. RESULTS: Between January 2016 and April 2020, 846 eligible patients receiving intermediate-risk regimens were registered to either SOE to prescribe (12 sites: n = 542) or an alert to not prescribe PP-CSF (12 sites: n = 304). Rates of PP-CSF use were higher among sites randomized to SOE (37.1% v 9.9%, odds ratio, 5.91; 95% CI, 1.77 to 19.70; P = .0038). Rates of FN were low and identical between arms (3.7% v 3.7%). CONCLUSION: Although implementation of a SOE intervention for PP-CSF significantly increased PP-CSF use among patients receiving first-line intermediate-risk regimens, FN rates were low and did not differ between arms. Although this guideline-informed SOE influenced prescribing, the results suggest that neither SOE nor PP-CSF provides sufficient benefit to justify their use for all patients receiving first-line intermediate-risk regimens.

Effects of a Guideline-Informed Clinical Decision Support System Intervention to Improve Colony-Stimulating Factor Prescribing: A Cluster Randomized Clinical Trial.

Importance: Colony-stimulating factors are prescribed to patients undergoing chemotherapy to reduce the risk of febrile neutropenia. Research suggests that 55% to 95% of colony-stimulating factor prescribing is inconsistent with national guidelines. Objective: To examine whether a guideline-based standing order for primary prophylactic colony-stimulating factors improves use and reduces the incidence of febrile neutropenia. Design, Setting, and Participants: This cluster randomized clinical trial, the Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER), involved 32 community oncology clinics in the US. Participants were adult patients with breast, colorectal, or non-small cell lung cancer initiating cancer therapy and enrolled between January 2016 and April 2020. Data analysis was performed from July to October 2021. Interventions: Sites were randomized 3:1 to implementation of a guideline-based primary prophylactic colony-stimulating factor standing order system or usual care. Automated orders were added for high-risk regimens, and an alert not to prescribe was included for low-risk regimens. Risk was based on National Comprehensive Cancer Network guidelines. Main Outcomes and Measures: The primary outcome was to find an increase in colony-stimulating factor use among high-risk patients from 40% to 75%, a reduction in use among low-risk patients from 17% to 7%, and a 50% reduction in febrile neutropenia rates in the intervention group. Mixed model logistic regression adjusted for correlation of outcomes within a clinic. Results: A total of 2946 patients (median [IQR] age, 59.0 [50.0-67.0] years; 2233 women [77.0%]; 2292 White [79.1%]) were enrolled; 2287 were randomized to the intervention, and 659 were randomized to usual care. Colony-stimulating factor use for patients receiving high-risk regimens was high and not significantly different between groups (847 of 950 patients [89.2%] in the intervention group vs 296 of 309 patients [95.8%] in the usual care group). Among high-risk patients, febrile neutropenia rates for the intervention (58 of 947 patients [6.1%]) and usual care (13 of 308 patients [4.2%]) groups were not significantly different. The febrile neutropenia rate for patients receiving high-risk regimens not receiving colony-stimulating factors was 14.9% (17 of 114 patients). Among the 585 patients receiving low-risk regimens, colony-stimulating factor use was low and did not differ between groups (29 of 457 patients [6.3%] in the intervention group vs 7 of 128 patients [5.5%] in the usual care group). Febrile neutropenia rates did not differ between usual care (1 of 127 patients [0.8%]) and the intervention (7 of 452 patients [1.5%]) groups. Conclusions and Relevance: In this cluster randomized clinical trial, implementation of a guideline-informed standing order did not affect colony-stimulating factor use or febrile neutropenia rates in high-risk and low-risk patients. Overall, use was generally appropriate for the level of risk. Standing order interventions do not appear to be necessary or effective in the setting of prophylactic colony-stimulating factor prescribing. Trial Registration: ClinicalTrials.gov Identifier: NCT02728596.

Barriers associated with inadequate follow-up of abnormal fecal immunochemical test results in a safety-net system: A mixed-methods analysis.

In safety-net healthcare systems, colonoscopy completion within 1-year of an abnormal fecal immunochemical test (FIT) result rarely exceeds 50%. Understanding how electronic health records (EHR) documented reasons for missed colonoscopy match or differ from patient-reported reasons, is critical to optimize effective interventions to address this challenge. We conducted a convergent mixed-methods study which included a retrospective analysis of EHR data and semi-structured interviews of adults 50-75 years old, with abnormal FIT results between 2014 and 2020 in a large safety-net healthcare system. Of the 299 patients identified, 59.2% (n = 177) did not complete a colonoscopy within one year of their abnormal result. EHR abstraction revealed a documented reason for lack of follow-up colonoscopy in 49.2% (n = 87/177); patient-level (e.g., declined colonoscopy; 51.5%) and multi-factorial reasons (e.g., lost to follow-up; 37.9%) were most common. In 18 patient interviews, patient (e.g., fear of colonoscopy), provider (e.g., lack of result awareness), and system-level reasons (e.g., scheduling challenges) were most common. Only three reasons for lack of colonoscopy overlapped between EHR data and patient interviews (competing health issues, lack of transportation, and abnormal FIT result attributed to another cause). In a cohort of safety-net patients with abnormal FIT results, the most common reasons for lack of follow-up were patient-related. Our analysis revealed a discordance between EHR documented and patient-reported reasons for lack of colonoscopy after an abnormal FIT result. Mixed-methods analyses, as in the present study, may give us the greatest insight into modifiable determinants to develop effective interventions beyond quantitative and qualitative data analysis alone.

Successes and challenges of implementing a cancer care delivery intervention in community oncology practices: lessons learned from SWOG S1415CD.

BACKGROUND: Cancer Care Delivery (CCD) research studies often require practice-level interventions that pose challenges in the clinical trial setting. The SWOG Cancer Research Network (SWOG) conducted S1415CD, one of the first pragmatic cluster-randomized CCD trials to be implemented through the National Cancer Institute (NCI) Community Oncology Program (NCORP), to compare outcomes of primary prophylactic colony stimulating factor (PP-CSF) use for an intervention of automated PP-CSF standing orders to usual care. The introduction of new methods for study implementation created challenges and opportunities for learning that can inform the design and approach of future CCD interventions. METHODS: The order entry system intervention was administered at the site level; sites were affiliated NCORP practices that shared the same chemotherapy order system. 32 sites without existing guideline-based PP-CSF standing orders were randomized to the intervention (n = 24) or to usual care (n = 8). Sites assigned to the intervention participated in tailored training, phone calls and onboarding activities administered by research team staff and were provided with additional funding and external IT support to help them make protocol required changes to their order entry systems. RESULTS: The average length of time for intervention sites to complete reconfiguration of their order sets following randomization was 7.2 months. 14 of 24 of intervention sites met their individual patient recruitment target of 99 patients enrolled per site. CONCLUSIONS: In this paper we share seven recommendations based on lessons learned from implementation of the S1415CD intervention at NCORP community oncology practices representing diverse geographies and patient populations across the U. S. It is our hope these recommendations can be used to guide future implementation of CCD interventions in both research and community settings. TRIAL REGISTRATION: NCT02728596 , registered April 5, 2016.

Operationalizing a Rideshare Intervention for Colonoscopy Completion: Barriers, Facilitators, and Process Recommendations.

INTRODUCTION: Transportation is a common barrier to colonoscopy completion for colorectal cancer (CRC) screening. The study aims to identify the barriers, facilitators, and process recommendations to implement a rideshare non-emergency medical transportation (NEMT) intervention following colonoscopy completion within a safety-net healthcare setting. METHODS: We used informal stakeholder engagement, story boards - a novel user-centered design technique, listening sessions and the nominal group technique to identify the barriers, facilitators, and process to implementing a rideshare NEMT program following colonoscopy completion in a large safety-net healthcare system. RESULTS: Barriers to implementing a rideshare NEMT intervention for colonoscopy completion included: inability to expand an existing NEMT program beyond Medicaid patients and lack of patient chaperones with rideshare NEMT programs. Facilitators included: commercially available rideshare NEMT platforms that were lower cost and had shorter wait times than the alternative of taxis. Operationalizing and implementing a rideshare NEMT intervention in our healthcare system required the following steps: 1) identifying key stakeholders, 2) engaging stakeholder groups in discussion to identify barriers and solutions, 3) obtaining institutional sign-off, 4) developing a process for reviewing and selecting a rideshare NEMT program, 5) executing contracts, 6) developing a standard operating procedure and 7) training clinic staff to use the rideshare platform. DISCUSSION: Rideshare NEMT after procedural sedation is administered may improve colonoscopy completion rates and provide one solution to inadequate CRC screening. If successful, our rideshare model could be broadly applicable to other safety-net health systems, populations with high social needs, and settings where procedural sedation is administered.

Perceptions on Barriers and Facilitators to Colonoscopy Completion After Abnormal Fecal Immunochemical Test Results in a Safety Net System.

Importance: The effectiveness of stool-based colorectal cancer (CRC) screening, including fecal immunochemical tests (FITs), relies on colonoscopy completion among patients with abnormal results, but in safety net systems and federally qualified health centers, in which FIT is frequently used, colonoscopy completion within 1 year of an abnormal result rarely exceeds 50%. Clinician-identified factors in follow-up of abnormal FIT results are understudied and could lead to more effective interventions to address this issue. Objective: To describe clinician-identified barriers and facilitators to colonoscopy completion among patients with abnormal FIT results in a safety net health care system. Design, Setting, and Participants: This qualitative study was conducted using semistructured key informant interviews with primary care physicians (PCPs) and staff members in a large safety net health care system in Washington state. Eligible clinicians were recruited through all-staff meetings and clinic medical directors. Interviews were conducted from February to December 2020 through face-to-face interactions or digital meeting platforms. Interview transcripts were analyzed deductively and inductively using a content analysis approach. Data were analyzed from September through December 2020. Main Outcomes and Measures: Barriers and facilitators to colonoscopy completion after an abnormal FIT result were identified by PCPs and staff members. Results: Among 21 participants, there were 10 PCPs and 11 staff members; 20 participants provided demographic information. The median (interquartile range) age was 38.5 (33.0-51.5) years, 17 (85.0%) were women, and 9 participants (45.0%) spent more than 75% of their working time engaging in patient care. All participants identified social determinants of health, organizational factors, and patient cognitive factors as barriers to colonoscopy completion. Participants suggested that existing resources that addressed these factors facilitated colonoscopy completion but were insufficient to meet national follow-up colonoscopy goals. Conclusions and Relevance: In this qualitative study, responses of interviewed PCPs and staff members suggested that the barriers to colonoscopy completion in a safety net health system may be modifiable. These findings suggest that interventions to improve follow-up of abnormal FIT results should be informed by clinician-identified factors to address multilevel challenges to colonoscopy completion.

Text Message Preferences for Surveillance Colonoscopy Reminders Among Colorectal Cancer Survivors.

Background. Surveillance colonoscopy 1-year after colorectal cancer (CRC) surgery effectively reduces CRC mortality, yet less than half of survivors undergo this procedure. Text message reminders can improve CRC screening and other health behaviors, but use of this strategy to address barriers to CRC surveillance has not been reported. Objectives. The goal of this qualitative study was to assess CRC survivor perspectives on barriers to colonoscopy to inform the design of a theory-based, short message service (SMS) intervention to increase surveillance colonoscopy utilization. Method. CRC survivors in Western Washington participated in one of two focus groups to explore perceived barriers to completing surveillance colonoscopy and preferences for SMS communication. Content analysis using codes representative of the health belief model and prospect theory constructs were applied to qualitative data. Results. Thirteen CRC survivors reported individual-, interpersonal-, and system-level barriers to surveillance colonoscopy completion. Participants were receptive to receiving SMS reminders to mitigate these barriers. They suggested that reminders offer supportive, loss-framed messaging; include educational content; and be personalized to communication preferences. Finally, they recommended that reminders begin no earlier than 9 months following CRC surgery and not include response prompts. Conclusions. Our study demonstrates that CRC survivors perceive SMS reminders as an acceptable, valuable tool for CRC surveillance. Furthermore, there may be value in integrating theoretical frameworks to design, implement, and evaluate SMS interventions to address barriers to CRC surveillance. As physicians play a key role in CRC surveillance, provider- and system-level interventions that could additively improve the impact of SMS interventions are also worth exploring.

Effective stakeholder engagement: design and implementation of a clinical trial (SWOG S1415CD) to improve cancer care.

BACKGROUND: The Fred Hutchinson Cancer Research Center has engaged an External Stakeholder Advisory Group (ESAG) in the planning and implementation of the TrACER Study (S1415CD), a five-year pragmatic clinical trial assessing the effectiveness of a guideline-based colony stimulating factor standing order intervention. The trial is being conducted by SWOG through the National Cancer Institute Community Oncology Research Program in 45 clinics. The ESAG includes ten patient partners, two payers, two pharmacists, two guideline experts, four providers and one medical ethicist. This manuscript describes the ESAG's role and impact on the trial. METHODS: During early trial development, the research team assembled the ESAG to inform plans for each phase of the trial. ESAG members provide feedback and engage in problem solving to improve trial implementation. Each year, members participate in one in-person meeting, web conferences and targeted email discussion. Additionally, they complete a survey that assesses their satisfaction with communication and collaboration. The research team collected and reviewed stakeholder input from 2014 to 2018 for impact on the trial. RESULTS: The ESAG has informed trial design, implementation and dissemination planning. The group advised the trial's endpoints, regimen list and development of cohort and usual care arms. Based on ESAG input, the research team enhanced patient surveys and added pharmacy-related questions to the component application to assess order entry systems. ESAG patient partners collaborated with the research team to develop a patient brochure and study summary for clinic staff. In addition to identifying recruitment strategies and patient-oriented platforms for publicly sharing results, ESAG members participated as co-authors on this manuscript and a conference poster presentation highlighting stakeholder influence on the trial. The annual satisfaction survey results suggest that ESAG members were satisfied with the methods, frequency and target areas of their engagement in the trial during project years 1-3. CONCLUSIONS: Diverse stakeholder engagement has been essential in optimizing the design, implementation and planned dissemination of the TrACER Study. The lessons described in the manuscript may assist others to effectively partner with stakeholders on clinical research.