Establishing requirements for technology to support clinical trial retention: a systematic scoping review and analysis using self-determination theory (Preprint)

BACKGROUND Retaining participants in clinical trials is an established challenge. Presently the industry is moving to a technology-mediated, decentralised model for running trials. The shift presents an opportunity for technology design to aid the participant experience and promote retention, but there are many open questions regarding how this can be best supported. We advocate that a stronger theoretical position is required to improve the quality of design decisions for clinical trial technology to promote participant engagement. OBJECTIVE This study aims to identify and analyse the types of retention strategies used in published clinical trials that successfully retain participants. METHODS A systematic scoping review was carried out on six electronic databases from 1990 up until September 2020, including Cumulative Index to Nursing and Allied Health Literature (CINAHL), The Cochrane Library, EBSCO, Embase, PsycINFO, and Pub med using the concepts 'retention', 'strategy,' 'clinal trial', and 'clinical research'. This was followed by an analysis of the articles through the lens of Self-Determination Theory (Deci and Ryan 2012), an evidence-based theory of human motivation. RESULTS Twenty-six articles were included for review. The motivational strategies identified in clinical trials in our sample were categorised into eight themes, including 1. Autonomy, 2. Competence, 3. Relatedness, 4. Controlled Motivation, 5. Branding, communications material, and marketing literature, 6. Contact, tracking, scheduling methods and data collection, 7. Convenience to participate in order to collect data, and 8. Organisational competence. Trials used a wide range of motivational strategies. Notably, trials often relied on controlled motivation interventions and under-utilised strategies to support intrinsic motivation. Also, traditional clinical trials rely heavily on human interaction and ‘relatedness’ to support motivation and retention, which may cause problems in the move to the technology-led decentralised trials. We found inconsistency in data reporting methods and that motivational theory-based approaches were not evident in strategy design. CONCLUSIONS The study offers direction and a framework to guide future decentralised clinical trial (DCT) digital technology design decisions to enhance participant retention during clinical trials. The research defines previous clinical trial retention strategies in terms of participant motivation, identifies motivational strategies and offers a rationale for selecting strategies that will improve retention. The research emphasizes the benefits of using theoretical frameworks to analyse strategic approaches and aid decision making to improve the quality of technology design decisions.