A multilevel framework for recruitment and retention in implementation trials: An illustrative example

Background: Implementation and hybrid effectiveness-implementation trials aspire to speed the translation of science into practice by generating crucial evidence for improving the uptake of effective health interventions. By design, they pose unique recruitment and retention challenges due to their aims, units of analysis, and sampling plans, which typically require many clinical sites (i.e. often 20 or more) and participation by individuals who are related across multiple levels (e.g. linked organizational leaders, clinicians, and patients). In this article, we present a new multilevel, theory-informed, and relationship-centered framework for conceptualizing recruitment and retention in implementation and hybrid effectiveness-implementation trials which integrates and builds on prior work on recruitment and retention strategies in patient-focused trials. We describe the framework's application in the Working to Implement and Sustain Digital Outcome Measures hybrid type III trial, which occurred in part during the COVID-19 pandemic.

Methods: Recruitment for the Working to Implement and Sustain Digital Outcome Measures trial occurred from October 2019 to February 2022. Development of recruitment and retention strategies was guided by a newly developed multilevel framework, which targeted the capability, opportunity, and motivation of organizational leaders, clinicians, patient-facing administrative staff, and patients to engage in research. A structured assessment guide was developed and applied to refine recruitment and retention approaches throughout the trial. We describe the framework and its application amid the onset of the COVID-19 pandemic which required rapid adjustments to address numerous barriers.

Results: The Working to Implement and Sustain Digital Outcome Measures trial enrolled 21 outpatient clinics in three US states, incorporating 252 clinicians and 686 caregivers of youth (95% of patient recruitment target) across two distinct phases. Data completion rates for organizational leaders and clinicians averaged 90% over five waves spanning 18 months, despite the onset of the COVID pandemic. Caregiver completion rates of monthly follow-up assessments ranged from 80%-88% across 6 months. This article presents the multilevel framework, assessment guide, and strategies used to achieve recruitment and retention targets at each level.

Conclusion: We conducted a multi-state hybrid type III effectiveness-implementation trial that maintained high recruitment and retention across all relevant levels amid a global pandemic. The newly developed multilevel recruitment and retention framework and assessment guide presented here, which integrates behavioral theory, a relationship-focused lens, and evidence-based strategies for participant recruitment and retention at multiple levels, can be adapted and used by other researchers for implementation, hybrid, and multilevel pragmatic trials as well as other implementation studies.