Clinical trial recruitment is a continuing challenge for medical researchers. Previous efforts to improve study recruitment have rarely been informed by theories of human decision making and behaviour change. We investigate the trial recruitment strategies reported by study recruiters, guided by two influential frameworks: shared decision-making (SDM) and the Theoretical Domains Framework (TDF).
We interviewed nine study recruiters from a multi-site, open-label pilot study assessing the feasibility of a large-scale randomized trial. Recruiters were primarily nurses or masters-level research assistants with a range of 3 to 30 years of experience. The semi-structured interviews included icebreaker questions, questions about the typical recruitment encounter, questions concerning the main components of SDM (e.g. verifying understanding, directive vs. non-directive style), and questions investigating the barriers to and drivers of recruitment, based on the TDF. We used directed content analysis to code quotations into TDF domains, followed by inductive thematic analysis to code quotations into sub-themes within domains and overarching themes across TDF domains. Responses to questions related to SDM were aggregated according to level of endorsement, and informed the thematic analysis.
The inductive analysis revealed 28 subthemes across 11 domains. The subthemes were organized into six overarching themes: coordinating between people, providing guidance to recruiters about challenges, providing resources to recruiters, optimizing study flow, guiding the recruitment decision, and emphasizing the benefits to participation. The SDM analysis revealed recruiters were able to view recruitment interactions as successful even when enrollment did not proceed, and most recruiters took a non-directive (i.e. providing patients with balanced information on available options) or mixed approach over a directive approach (i.e. focus on enrolling patient in study). Most of the core SDM constructs were frequently endorsed.
Identified subthemes can be linked to TDF domains for which effective behaviour change interventions are known, yielding interventions that can be evaluated as to whether they improve recruitment. Despite having no formal training in shared decision making, study recruiters reported practices consistent with many elements of SDM. The development of SDM training materials specific to trial recruitment could improve the informed decision-making process for patients.