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

Area of Science:

• Clinical Trials
• Surgical Research
• Health Services Research

Background:

• Recruitment challenges are common in randomized controlled trials (RCTs), often preventing trials from meeting enrollment targets.
• Randomized feasibility studies can proactively identify and address recruitment barriers before a main trial.
• This study details the application of the QuinteT Recruitment Intervention (QRI) to enhance recruitment within the HAND-1 randomized feasibility study for Dupuytren's contracture surgical treatments.

Purpose of the Study:

• To implement and evaluate the QuinteT Recruitment Intervention (QRI) for optimizing participant recruitment in a surgical randomized feasibility study.
• To identify and address specific recruitment obstacles encountered during the HAND-1 study.
• To assess the value of feasibility studies and embedded interventions in refining RCT design and conduct.

Main Methods:

• The QRI was implemented in two phases: Phase 1 involved understanding challenges through staff interviews, screening log analysis, and consultation recordings.
• Phase 2 focused on delivering a tailored action plan, including recruiter feedback and training, to mitigate identified issues.
• Interventions included refining patient identification pathways and providing bespoke training on consent discussions to recruiters and centers.

Main Results:

• Key recruitment barriers identified were challenges in the patient identification pathway and equipoise among recruiters and patients regarding treatments.
• Collaborative efforts with trial centers improved recruitment pathways and shared best practices.
• The HAND-1 study successfully met its recruitment target following the implementation of the QRI.

Conclusions:

• The QuinteT Recruitment Intervention (QRI) effectively addressed recruitment challenges in a surgical feasibility study, leading to successful target achievement.
• Lessons learned from the QRI are transferable to the main trial and other surgical/similar RCTs facing issues with patient/recruiter equipoise and varied recruitment pathways.
• Feasibility studies incorporating interventions like the QRI are valuable for refining RCT design, conduct, and addressing recruitment issues in real-time.