Recruitment and Retention Strategies for the Diabetes RElated to Acute Pancreatitis and Its Mechanisms Study

Abstract

Recruitment and retention of patients with acute pancreatitis (AP) in clinical studies can be challenging. While some obstacles are similar to other clinical conditions, some are unique to AP. Identifying potential barriers early and developing targeted solutions can help optimize recruitment and retention in AP studies. Such pre-emptive and detailed planning can help prospective, longitudinal studies focus on exocrine and endocrine complications of AP in accurately measuring outcomes. This article highlights the challenges in recruitment and retention strategies in AP studies and reviews available resources to create opportunities to address them. We describe the multifaceted approach used by the Recruitment and Retention Committee of the Type 1 Diabetes in Acute Pancreatitis Consortium, which builds upon earlier experiences to develop a recruitment and retention plan for the DREAM (Diabetes RElated to Acute pancreatitis and its Mechanisms) study.

Rationale and Design for the Diabetes RElated to Acute Pancreatitis and Its Mechanisms Study

“…We sought guidance from T1DAPC investigators and the NIH representatives participating in recent and ongoing studies in pancreatitis to refine, and when possible harmonize, study definitions, data elements, case report forms, and research methodology 21–25 . Lastly, we have convened a recruitment and retention committee concurrently with study planning to provide guidance and feedback regarding implications of decisions on participant burden 26 . There is not a precedent in the United States for a prospective cohort study in AP of this scale, so we will prospectively monitor recruitment and retention rates, completion of study assessments, and collaboratively discuss any needs to alter the sample size, number, and/or frequency of study assessments to maintain feasibility.…”

“…[21][22][23][24][25] Lastly, we have convened a recruitment and retention committee concurrently with study planning to provide guidance and feedback regarding implications of decisions on participant burden. 26 There is not a precedent in the United States for a prospective cohort study in AP of this scale, so we will prospectively monitor recruitment and retention rates, completion of study assessments, and collaboratively discuss any needs to alter the sample size, number, and/or frequency of study assessments to maintain feasibility. Final decisions regarding modifications to the study protocol will be made by the T1DAPC steering committee and approved by the National Institutes of Diabetes and Digestive and Kidney Diseases, data and safety monitoring board, and single institutional review board before implementation.…”

Leveraging the Expertise of the CTSA Program to Increase the Impact and Efficiency of Clinical Trials

“…Following a literature review of best practices and consultations with recruitment specialists, the template was finalized and posted to the publicly accessible TIN Toolbox in January 2019, garnering more than 3500 views and usage in more than 82 studies to date. 21 and, if generalizable, may be considered for further evaluation, iterative development, and eventual broad dissemination as new TIN assets. In some cases, these assets are informational and disseminated via the online TIN Toolbox (eg, Gamification Guide, 24 Recruitment and Retention Planning Template 21 ).…”

“…To improve clinical trial recruitment planning and satisfy NIH grant submission recruitment planning requirements, the RIC developed a comprehensive recruitment and retention plan template. Following a literature review of best practices and consultations with recruitment specialists, the template was finalized and posted to the publicly accessible TIN Toolbox in January 2019, garnering more than 3500 views and usage in more than 82 studies to date …”

“…Consultations occasionally result in ideation for new innovations, which are first piloted at the individual trial level and, if generalizable, may be considered for further evaluation, iterative development, and eventual broad dissemination as new TIN assets. In some cases, these assets are informational and disseminated via the online TIN Toolbox (eg, Gamification Guide, Recruitment and Retention Planning Template). In other cases, innovations are embedded as new features in existing technical platforms for wider dissemination (eg, IREx for single IRB, ResearchMatch for recruitment and/or expert advice, FasterTogether Massive Open Online Course for guidance on engaging underrepresented communities in clinical research, and REDCap for Data Collection, eConsent, and EHR–to–electronic data capture data sourcing).…”