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

IF 2 4区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Trials Pub Date : 2024-12-18 DOI:10.1186/s13063-024-08655-z
Kathryn Harvey, Penelope Ralph, Llinos Haf Spencer, Kodchawan Doungsong, Val Morrison, Andrew Lemmey, Miriam Golding-Day, Susanna Dodd, Ben Hardwick, Shanaz Dorkenoo, Sophie Hennessey, Nefyn Williams
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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.

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工作人员招募参与者参加髋部骨折后社区康复干预随机对照试验的障碍和促进因素。
背景:随机对照试验(RCTs)经常在招募方面遇到困难,许多需要延长,这导致有效干预措施的实施延迟。复杂干预试验的招募也有类似的困难。此外,COVID-19大流行对试验招募产生了重大影响。研究表明,许多其他征聘问题是可以预见的,例如,过高估计目标人口的流行率;然而,一系列因素可能起作用。本研究的目的是从招聘人员的角度探讨招聘的促进因素和障碍。方法:老年骨折多学科康复- III期(FEMuR III)是一项60岁以上髋部骨折患者术后复杂干预的随机对照试验。在2022年11月至2023年3月期间,对7名招聘人员进行了流程评估和半结构化访谈,以确定招聘的障碍和促进因素。在NVIVO(版本12)中使用批判现实主义视角进行了主题分析。结果:该试验主要在COVID-19大流行期间进行,并考虑了其对报告障碍的独特影响。一个重要的发现包括招募者不愿意接近他们认为由于其他因素(例如合并症或复杂的生活情况)而不会从试验中受益的患者。招募护工的一个可能障碍似乎是,家庭成员与“护工”的标签无关,因此不参与。引导者包括招聘人员与其他临床或研究人员一起接近患者。这种方法,包括量身定制的试验初始信息,通过增加患者对招募人员的熟悉程度,并允许工作人员有时间与患者建立关系,减少了参与者的压力。结论:本文确定了招募FEMuR III的障碍和促进因素,并为定性数据合成中确定的障碍和促进因素提供了六大主题。COVID-19大流行的影响是招聘的主要障碍,但不是唯一的障碍。主要发现涉及不愿接近一些符合条件的患者、“护理人员”的标签、临床工作人员的参与以及患者对试验组的偏好。强调了确定和克服招募问题的战略,并应在复杂干预措施的进一步随机对照试验中加以实施和评估。试验注册:ISRCTN28376407。2018年11月23日。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Trials
Trials 医学-医学:研究与实验
CiteScore
3.80
自引率
4.00%
发文量
966
审稿时长
6 months
期刊介绍: Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.
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