Understanding recruitment to a perioperative randomised controlled trial: protocol for a mixed-methods substudy nested within a feasibility trial of octreotide infusion during liver transplantation

Abstract

Abstract Introduction Recruitment to perioperative randomised controlled trials is known to be challenging. Qualitative methods offer insight into barriers and enablers to participation. This is a substudy within a feasibility randomised controlled trial of octreotide infusion during liver transplantation at two National Health Service hospitals, which will evaluate patient and staff experiences of trial processes. By sharing formative understanding from these methods with the trials team we aim to improve staff–patient interactions and hence recruitment rates.

Methods and analysis This prospective mixed-methods study will comprise two workstreams. First, after consent to the randomised controlled trial is sought, all patients will be invited to complete a questionnaire to explore their perceptions of the information given to them and motivating factors that influenced their decision to consent or not. Questionnaires will be analysed using descriptive statistics and framework analysis.

If the recruitment:approach ratio drops below a predetermined ratio or if there are any specific recruitment concerns from the trials team, a second workstream involving mixed-methods fieldwork will be implemented. This will involve audiorecording of recruitment consultations and a follow-up semistructured interview to explore patients’ perception of their decision-making regarding recruitment. Semistructured interviews will also be conducted with the recruitment team to establish their views about the trial, barriers to recruitment and ways to overcome them. Recruitment consultations will be analysed using Q-QAT methodology and interviews will be analysed using framework analysis. Findings from both workstreams will be formatively fed back to the trials team to enable iterative improvement to recruitment processes.

Ethics and dissemination Approval has been granted by Greater Manchester West Research Ethics Committee (ref 20/NW/0071), the Health Research Authority and the local Research and Development offices. A manuscript detailing the summative findings will be submitted to peer-reviewed journals.

Trial registration number NCT04941911.