Optimising recruitment to the HAND-1 RCT feasibility study: integration of the QuinteT Recruitment Intervention (QRI)

Husbands, Samantha; Elliott, Daisy; Davis, Tim R.C.; Blazeby, Jane M.; Harrison, Eleanor F.; Montgomery, Alan A.; Sprange, Kirsty; Duley, Lelia; Karantana, Alexia; Hollingworth, William; Mills, Nicola

Abstract

© 2020, The Author(s). Background: Recruitment to randomised controlled trials (RCTs) can be challenging, with most trials not reaching recruitment targets. Randomised feasibility studies can be set up prior to a main trial to identify and overcome recruitment obstacles. This paper reports on an intervention—the QuinteT Recruitment Intervention (QRI)—to optimise recruitment within a randomised feasibility study of surgical treatments for patients with Dupuytren’s contracture (the HAND-1 study). Methods: The QRI was introduced in 2-phases: phase 1 sought to understand the recruitment challenges by interviewing trial staff, scrutinising screening logs and analysing audio-recorded patient consultations; in phase 2 a tailored plan of action consisting of recruiter feedback and training was delivered to address the identified challenges. Results: Two key recruitment obstacles emerged: (1) issues with the recruitment pathway, in particular methods to identify potentially eligible patients and (2) equipoise of recruiters and patients. These were addressed by liaising with centres to share good practice and refine their pathway and by providing bespoke feedback and training on consent discussions to individual recruiters and centres whilst recruitment was ongoing. The HAND-1 study subsequently achieved its recruitment target. Conclusions: Transferable lessons learnt from the QRI in the feasibility study will be implemented in the definitive RCT, enabling a “head start” in the tackling of wider issues around screening methods and consent discussions in the set up/early recruitment study phases, with ongoing QRI addressing specific issues with new centres and recruiters. Findings from this study are likely to be relevant to other surgical and similar trials that are anticipated to encounter issues around patient and recruiter equipoise of treatments and variation in recruitment pathways across centres. The study also highlights the value of feasibility studies in fine-tuning design and conduct issues for definitive RCTs. Embedding a QRI in an RCT, at feasibility or main stage, offers an opportunity for a detailed and nuanced understanding of key recruitment challenges and the chance to address them in “real-time” as recruitment proceeds.

Citation

Husbands, S., Elliott, D., Davis, T. R., Blazeby, J. M., Harrison, E. F., Montgomery, A. A., Sprange, K., Duley, L., Karantana, A., Hollingworth, W., & Mills, N. (2020). Optimising recruitment to the HAND-1 RCT feasibility study: integration of the QuinteT Recruitment Intervention (QRI). Pilot and Feasibility Studies, 6(1), https://doi.org/10.1186/s40814-020-00710-1

• Journal Article Type: Article
• Acceptance Date: Oct 16, 2020
• Online Publication Date: Nov 9, 2020
• Publication Date: 2020-12
• Deposit Date: Jul 27, 2020
• Publicly Available Date: Nov 10, 2020
• Journal: Pilot and Feasibility Studies
• Electronic ISSN: 2055-5784
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• Volume: 6
• Issue: 1
• DOI: https://doi.org/10.1186/s40814-020-00710-1
• Keywords: : Feasibility study, Randomised controlled trial, Surgical randomised controlled trial, Recruitment, Recruitment obstacles, Recruitment intervention, Informed consent, Qualitative, Equipoise
• Public URL: https://nottingham-repository.worktribe.com/output/4792545
• Publisher URL: https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-020-00710-1
• Additional Information: Received: 24 September 2019; Accepted: 16 October 2020; First Online: 9 November 2020; : Ethical approval for the RCT and embedded QRI research was given by the East Midlands—Derby Research Ethics Committee (ref, 15/EM/0197). Informed written consent was obtained from all participants to audio-record their consultations with a HAND-1 recruiter.; : Not applicable.; : The authors declare that they have no competing interests.