Project outputs

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Electronic recruitment and consent in a multi-centre randomised clinical trial in an orthopaedic trauma setting

Wagland S 1 , Appelbe D 1, Achten J 1 , Griffin XL 2

1 Oxford Trauma & Emergency Care, NDORMS, University of Oxford.

2 Blizard Institute, Barts & The London School of Medicine & Dentistry, Queen Mary University of London.

Introduction

Within a trauma or emergency setting, when limited time is available for the identification of eligible patients and the consent process, an in-clinic setting for recruitment is often favoured.

To date few trials, where prospective patient consent needs to be obtained in a more acute situation, have attempted to recruit without the patient and researcher sharing a location.

The Covid pandemic led to the introduction of alternative approaches to trial procedures. The option of recruiting patients to a clinical study without face-to-face contact was introduced into the FAME trial. In addition to potentially reducing infection risk it also could lead to reduced travel and save clinic and patient time.

Aims

To enhance recruitment with an entirely remote recruitment function.

Methods

Bespoke “virtual consent” function: research staff screened patients and consented them remotely.

Participant entered baseline data in a home setting, guided by research staff. Neither patient nor researcher need be present in the hospital.
Seamless link to REDCap, FAME’s clinical database and RRAMP randomisation system.
Researcher and patient required a phone, and internet browser access.
Training by central trials unit staff via a simple flowchart, and site training through remote meetings.

Virtual consent flowchart

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Results

Since virtual consent was introduced to the FAME trial, 34 participants have been randomised using virtual consent (5% of 657), across 10 of the 24 recruiting sites.