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Clinical Trial
. 2024 Dec 18;25(1):826.
doi: 10.1186/s13063-024-08655-z.

Perceived barriers and facilitators of staff recruiting participants to a randomised controlled trial of a community rehabilitation intervention following hip fracture

Kathryn Harvey  1 , Penelope Ralph  1 , Llinos Haf Spencer  2 , Kodchawan Doungsong  3 , Val Morrison  4 , Andrew Lemmey  4 , Miriam Golding-Day  5 , Susanna Dodd  6 , Ben Hardwick  7 , Shanaz Dorkenoo  8 , Sophie Hennessey  7 , Nefyn Williams  9
Affiliations
Clinical Trial

Perceived barriers and facilitators of staff recruiting participants to a randomised controlled trial of a community rehabilitation intervention following hip fracture

Kathryn Harvey et al. Trials. .

Abstract

Background: Randomised controlled trials (RCTs) often struggle with recruitment and many need extensions which leads to delayed implementation of effective interventions. Recruitment to complex intervention trials have similar difficulties. Alongside this, the COVID-19 pandemic had a major impact upon trial recruitment. Research has shown that many other recruitment issues can be anticipated, for example overestimating target population prevalence; however, a range of factors may play a role. The aim of this study is to investigate facilitators and barriers to recruitment from the perspective of the recruiter.

Methods: Fracture in the Elderly Multidisciplinary Rehabilitation - phase III (FEMuR III) was a RCT of a complex intervention post-surgery for hip fracture in patients over 60 years old. A process evaluation was undertaken, and semi-structured interviews were conducted with seven recruiters between November 2022 and March 2023 to identify barriers and facilitators to recruitment. A thematic analysis was undertaken in NVIVO (Version 12) using a critical realist perspective.

Results: The trial took place mostly during the COVID-19 pandemic, and the unique impact of this on reported barriers is considered. A key finding included recruiter reluctance to approach patients that they felt would not benefit from the trial due to other factors (e.g. comorbidities or complex living situations). A possible barrier to recruiting carers appeared to be that family members did not relate to the label of 'carer' and so did not take part. Facilitators included recruiters approaching patients with other clinical or research staff. This approach, which included tailored initial information on the trial, reduced participant stress by increasing patient familiarity with recruiting staff and allowing staff time to develop relationships with patients.

Conclusion: This paper identifies barriers and facilitators of recruitment to FEMuR III with six broad themes for both barriers and facilitators identified in the qualitative data synthesis. The impact of the COVID-19 pandemic was the main, but not sole, barrier to recruitment. Key findings concern reluctance to approach some eligible patients, the label of 'carer', the involvement of clinical staff and patient preference for trial group. Strategies to identify and overcome recruitment problems are highlighted and should be implemented and evaluated in further RCTs of complex interventions.

Trial registration: ISRCTN28376407. November 23, 2018.

Keywords: Community healthcare complex intervention; Elderly medicine; Qualitative; Recruitment; Rehabilitation.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: NHS research ethics approval was obtained for the FEMuR III trial from North East—Tyne & Wear South Research Ethics Committee, reference 18/NE/0300. Consent for publication: Not applicable. Competing interests: NHW is deputy chair of the National Institute for Health and Care Research Health Technology Assessment programme funding committee (commissioned research).

Figures

Fig. 1
Fig. 1
FEMuR III Recruitment Graph showing number of centres opened alongside number of participants randomised
See this image and copyright information in PMC

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