Optimising the efficiency of identifying and addressing trial recruitment issues through pre-trial and ‘real-time’ qualitative investigation
Brighton, UK

Speaker: Leila Rooshenas

This is a talk at the International Clinical Trials Methodology Conference (ICTMC), Brighton, UK, 6th – 9th October 2019.  Venue is the Hilton Brighton Metropole.

Parallel Session 9D – Learning from Qualitative Research
Wednesday, Oct 9, 2019
8:45 AM – 9:50 AM

Dr Leila Rooshenas1, Dr Samantha Husbands1, Dr Alba Realpe1, Prof Jenny Donovan1, Dr Fergus Caskey1, On behalf of the Prepare for Kidney Care study team1

1University of Bristol, United Kingdom

Introduction: Qualitative research is increasingly used to enhance the conduct of randomised controlled trials (RCTs) – particularly recruitment. The QuinteT Recruitment Intervention (QRI) investigates recruitment issues in ‘real-time’ to inform tailored solutions as the trial proceeds. Qualitative research may also be conducted at the pre-trial stage to understand anticipated recruitment issues. We combined pre-trial and ‘real-time’ (QRI) investigation of recruitment issues in the Prepare for Kidney Care RCT: a challenging trial comparing the (cost)-effectiveness of ‘preparing for dialysis’ or ‘conservative care’. This methodological sub-study aimed to compare the insights/actions generated from each stage of qualitative work, to examine if/how findings could be used to enhance the efficiency of addressing recruitment challenges.

Methods: Pre-trial work: observations of introductory site-visits and interviews with clinical professionals (n=16) from forthcoming recruiting sites. ‘Real-time’ investigation included audio-recordings of recruitment discussions between recruiters/patients (n=38), interviews with recruiters (n=16), and descriptive analyses of screening-log data.

Findings: The pre-trial investigation highlighted professionals’ concerns around patients holding treatment-preferences, as many sites advocated ‘future-treatment-planning’ earlier in the disease trajectory relative to the point at which patients became eligible. Professionals also anticipated that patients/relatives may be concerned about forgoing dialysis. This informed refinements to the presentation of the trial arms, whilst issues less amenable to change (e.g. eligibility criteria) became focal points for the ‘real-time’ investigation. The ‘real-time’ investigation confirmed that recruiters were reluctant to approach patients with ‘future-treatment-plans’, which was addressed through specific training/guidance disseminated early on. Unanticipated issues also arose: patients generally held preferences for conservative care, although audio-recorded recruitment discussions indicated this could be shaped by recruiters’ information provision. Communication-related feedback/training and guidance around approaching was delivered iteratively, coinciding with improved recruitment per site/month over time.

Conclusion: Combining pre-trial and ‘real-time’ qualitative research can provide an effective means of optimising, through a blend of pre-emptive and responsive actions.

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