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

Area of Science:

• Health Services Research
• Implementation Science
• Clinical Trial Design

Background:

• Implementation and hybrid effectiveness-implementation trials accelerate the adoption of effective health interventions.
• These trials face unique recruitment and retention challenges due to multi-level participant engagement and numerous clinical sites.
• A novel multilevel, theory-informed, and relationship-centered framework is presented to address these challenges.

Purpose of the Study:

• To introduce a new multilevel framework for recruitment and retention in implementation and hybrid effectiveness-implementation trials.
• To describe the application of this framework in the Working to Implement and Sustain Digital Outcome Measures (WISP-DOM) trial.
• To detail strategies used to overcome recruitment and retention barriers, including those posed by the COVID-19 pandemic.

Main Methods:

• Development of recruitment and retention strategies guided by a multilevel framework targeting organizational leaders, clinicians, administrative staff, and patients.
• Application of a structured assessment guide to refine approaches throughout the WISP-DOM trial.
• Adaptation of strategies in response to the COVID-19 pandemic.

Main Results:

• The WISP-DOM trial successfully enrolled 21 clinics, 252 clinicians, and 686 caregivers, meeting 95% of the patient recruitment target.
• High data completion rates were achieved: 90% for leaders/clinicians and 80%-88% for caregivers, despite the pandemic.
• The study demonstrates successful recruitment and retention across multiple levels.

Conclusions:

• A multi-state hybrid type III trial successfully maintained high recruitment and retention across all levels during a global pandemic.
• The presented multilevel framework, integrating behavioral theory and evidence-based strategies, can be adapted for various trial types.
• This framework offers a valuable tool for researchers conducting implementation, hybrid, and multilevel pragmatic trials.