The impact of embedding trial recruitment into a clinical care pathway

Kay Por Yip, Simon Gompertz, Catherine Snelson, Jeremy Willson, Shyam Madathil, Syed Huq, Farrukh Rauf, Natasha Salmon, Julie Tracey, Brendan Cooper, Kay Filby, Dhruv Parekh, Davinder Dosanjh

Research output: Contribution to journalAbstractpeer-review

Abstract

Introduction: Care pathways translate clinical guidelines into care processes within a healthcare institution. Traditionally, clinical research is used to inform the evidence base and hence the architecture of such pathways. Where the evidence is unclear, the impact of using such pathways to aide recruitment to clinical research has not been evaluated.

Objective: To assess the effect of integrating research into a clinical care pathway.

Methods: Recruitment to the RECOVERY-RS trial, evaluating the use of continuous positive airway pressure (CPAP) and high-flow nasal oxygen (HFNO) in those with severe COVID19-associated hypoxia, commenced at the Queen Elizabeth Hospital Birmingham on 20/04/2020. A Respiratory Support Unit (RSU) was established on 11/01/2021. Recruitment to RECOVERY-RS was integrated into the admission pathway to the RSU. Recruitment to the trial was assessed pre- and post-RSU establishment, 20/04/2020 to 15/02/2021. The proportion of patients who received CPAP/HFNO as part of the trial compared to those initiated outside of the trial was also determined over the same timeframe.

Results: 51 patients were enrolled to RECOVERY-RS pre-RSU and 94 patients recruited post-RSU. During the pre-RSU period, 101 patients were initiated on CPAP/HFNO; 35(33.7%) of them via trial randomisation. After RSU formation, 64 patients were initiated on CPAP/HFNO; all of them (100%) through trial randomisation (p
Conclusions: Care pathways represent an opportunity to recruit patients into clinical trials. This is important in areas where the evidence base is scarce. In order to succeed, all parties involved in patient care have to agree to equipoise between trial treatment arms.
Original languageEnglish
Article numberPA1763
JournalEuropean Respiratory Journal
Volume58
Issue numbersuppl 65
DOIs
Publication statusPublished - 25 Nov 2021

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