Affiliation:
1. Department of Health Promotion, Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands
2. Department of Endocrinology and Internal Medicine, Maastricht University Medical Centre (MUMC+), Maastricht, The Netherlands
Abstract
Background Effective recruitment of patients by health professionals is challenging but pivotal to the success of clinical trials. Many trials fail to include the required number of participants, which affects the power of the study, generalizability of results, and timely dissemination of positive outcomes. Existing research is inconclusive regarding factors influencing recruitment results, and most research does not focus on perceptions of recruiting health professionals themselves. Therefore, thorough evaluations of recruitment facilitators and barriers in trials are needed in order to optimize future patient recruitment in trials. We observed divergent recruitment results among nurses who recruited diabetes patients to our trial, which examined the effectiveness of an eHealth programme. Therefore, we aimed to describe nurses’ recruitment results and related shifts over time, and to qualitatively explore factors influencing nurses’ recruitment results. Methods Nurses’ recruitment results and related temporal shifts were derived from trial data (NTR6840). Based on their recruitment results, nurses were categorized as non-, low-, medium-, or high-recruiters. Subsequently, a subset of nurses per group participated in an individual semi-structured telephone interview. Interviews were analysed using NVivo software, applying an inductive coding approach. Results Ninety-six nurses participated in our trial and recruited on average seven patients (range: 0–32). Fifteen nurses did not recruit any patients. Most patients were recruited close to recruitment onset. Nurses who did not recruit patients close to recruitment onset generally ended up recruiting no patients. Data show a relatively high number of early recruited patients that progressively declined over time. High-recruiters were generally successful throughout the entire recruitment period. Recruitment facilitators and barriers comprised organizational, study, patient, and especially recruiter characteristics. Contrary to non- and low-recruiters, medium- and high-recruiters reported more in-depth knowledge about the study and trial requirements, expressed more personal participation-related benefits and fewer barriers, and incorporated more recruitment activities, reminders, and barrier-focused coping strategies. Conclusion and implications To optimize patient recruitment to clinical trials, suggested intervention targets include the continued inclusion of recruiters after initial recruitment onset and the encouragement of early recruitment success. A personalized approach may aid recruiters to become and remain successful. Primarily, it is important to provide recruiters with sufficient information on trial requirements and to address salient benefits for participation in the trial, both for themselves and for their patients. Finally, teaching recruiters skills on how to overcome barriers may further enhance motivation and recruitment capacities.
Subject
Pharmacology,General Medicine