Successful Recruitment to Trials: Findings from the SCIMITAR+ Trial

Overview

Journal Trials

Publisher Biomed Central

Specialties General Medicine
Pharmacology

Date 2018 Jan 21

PMID 29351792

Citations 16

Authors

Emily Peckham

Catherine Arundel

Della Bailey

Tracy Callen

Christina Cusack

Suzanne Crosland

Penny Foster

Hannah Herlihy

James Hope

Suzy Ker

Tayla McCloud

Crystal-Bella Romain-Hooper

Alison Stribling

Peter Phiri

Ellen Tait

Simon Gilbody

Affiliations

Soon will be listed here.

Abstract

Background: Randomised controlled trials (RCT) can struggle to recruit to target on time. This is especially the case with hard to reach populations such as those with severe mental ill health. The SCIMITAR+ trial, a trial of a bespoke smoking cessation intervention for people with severe mental ill health achieved their recruitment ahead of time and target. This article reports strategies that helped us to achieve this with the aim of aiding others recruiting from similar populations.

Methods: SCIMITAR+ is a multi-centre pragmatic two-arm parallel-group RCT, which aimed to recruit 400 participants with severe mental ill health who smoke and would like to cut down or quit. The study recruited primarily in secondary care through community mental health teams and psychiatrists with a smaller number of participants recruited through primary care. Recruitment opened in October 2015 and closed in December 2016, by which point 526 participants had been recruited. We gathered information from recruiting sites on strategies which led to the successful recruitment in SCIMITAR+ and in this article present our approach to trial management along with the strategies employed by the recruiting sites.

Results: Alongside having a dedicated trial manager and trial management team, we identified three main themes that led to successful recruitment. These were: clinicians with a positive attitude to research; researchers and clinicians working together; and the use of NHS targets. The overriding theme was the importance of relationships between both the researchers and the recruiting clinicians and the recruiting clinicians and the participants.

Conclusions: This study makes a significant contribution to the limited evidence base of real-world cases of successful recruitment to RCTs and offers practical guidance to those planning and conducting trials. Building positive relationships between clinicians, researchers and participants is crucial to successful recruitment.

Citing Articles

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Phillips M, Ince B, Webb H, Dalton B, McCombie C, Irish M Eur Eat Disord Rev. 2023; 31(4):489-504.

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Barriers and facilitators to the recruitment of disabled people to clinical trials: a scoping review.

Shariq S, Cardoso Pinto A, Budhathoki S, Miller M, Cro S Trials. 2023; 24(1):171.

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A smoking cessation intervention for people with severe mental illness treated in ambulatory mental health care (KISMET): study protocol of a randomised controlled trial.

Kucukaksu M, van Meijel B, Jansen L, Hoekstra T, Adriaanse M BMC Psychiatry. 2023; 23(1):108.

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PMID: 36691692 PMC: 9969810. DOI: 10.1002/eahr.500154.

Recruiting and retaining participants in three randomised controlled trials of psychological interventions conducted on acute psychiatric wards: top ten tips for success.

Jacobsen P, Haddock G, Raphael J, Peak C, Winter R, Berry K BJPsych Open. 2022; 8(4):e125.

PMID: 35796538 PMC: 9301765. DOI: 10.1192/bjo.2022.527.

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