TY - JOUR

T1 - Perceived barriers and facilitators of staff recruiting participants to a randomised controlled trial of a community rehabilitation intervention following hip fracture

AU - Kathryn Harvey

AU - Penelope Ralph

AU - Llinos Haf Spencer

AU - Doungsong, Pim

AU - Morrison, Val

AU - Lemmey, Andrew

AU - Miriam Golding-Day

AU - Susanna Dodd

AU - Ben Hardwick

AU - Shanaz Dorkenoo

AU - Sophie Hennessey

AU - Nefyn Williams

N1 - © 2024. The Author(s).

PY - 2024/12/18

Y1 - 2024/12/18

N2 - BackgroundRandomised 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.MethodsFracture 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.ResultsThe 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.ConclusionThis 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 registrationISRCTN28376407. November 23, 2018.

AB - BackgroundRandomised 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.MethodsFracture 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.ResultsThe 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.ConclusionThis 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 registrationISRCTN28376407. November 23, 2018.

KW - Aged

KW - Attitude of Health Personnel

KW - COVID-19/psychology

KW - Female

KW - Hip Fractures/rehabilitation

KW - Humans

KW - Male

KW - Middle Aged

KW - Patient Selection

KW - Randomized Controlled Trials as Topic

KW - SARS-CoV-2

U2 - 10.1186/s13063-024-08655-z

DO - 10.1186/s13063-024-08655-z

M3 - Article

C2 - 39695752

VL - 25

JO - Trials

JF - Trials

SN - 1745-6215

IS - 826

ER -