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试验人员对精神病数字干预招募障碍及应对方法的看法:一项试验中的定性研究

Perspectives of Trial Staff on the Barriers to Recruitment in a Digital Intervention for Psychosis and How to Work Around Them: Qualitative Study Within a Trial.

作者信息

Allan Stephanie, Mcleod Hamish, Bradstreet Simon, Bell Imogen, Whitehill Helen, Wilson-Kay Alison, Clark Andrea, Matrunola Claire, Morton Emma, Farhall John, Gleeson John, Gumley Andrew

机构信息

University of Glasgow, Glasgow, United Kingdom.

Orygen, Melbourne, Australia.

出版信息

JMIR Hum Factors. 2021 Mar 5;8(1):e24055. doi: 10.2196/24055.

Abstract

BACKGROUND

Recruitment processes for clinical trials of digital interventions for psychosis are seldom described in detail in the literature. Although trial staff have expertise in describing barriers to and facilitators of recruitment, a specific focus on understanding recruitment from the point of view of trial staff is rare, and because trial staff are responsible for meeting recruitment targets, a lack of research on their point of view is a key limitation.

OBJECTIVE

The primary aim of this study was to understand recruitment from the point of view of trial staff and discover what they consider important.

METHODS

We applied pluralistic ethnographic methods, including analysis of trial documents, observation, and focus groups, and explored the recruitment processes of the EMPOWER (Early Signs Monitoring to Prevent Relapse in Psychosis and Promote Well-being, Engagement, and Recovery) feasibility trial, which is a digital app-based intervention for people diagnosed with schizophrenia.

RESULTS

Recruitment barriers were categorized into 2 main themes: service characteristics (lack of time available for mental health staff to support recruitment, staff turnover, patient turnover [within Australia only], management styles of community mental health teams, and physical environment) and clinician expectations (filtering effects and resistance to research participation). Trial staff negotiated these barriers through strategies such as emotional labor (trial staff managing feelings and expressions to successfully recruit participants) and trying to build relationships with clinical staff working within community mental health teams.

CONCLUSIONS

Researchers in clinical trials for digital psychosis interventions face numerous recruitment barriers and do their best to work flexibly and to negotiate these barriers and meet recruitment targets. The recruitment process appeared to be enhanced by trial staff supporting each other throughout the recruitment stage of the trial.

摘要

背景

关于精神病数字干预临床试验的招募过程,文献中很少有详细描述。尽管试验工作人员在描述招募的障碍和促进因素方面具有专业知识,但很少有研究专门从试验工作人员的角度去理解招募情况,而且由于试验工作人员负责实现招募目标,缺乏对他们观点的研究是一个关键限制因素。

目的

本研究的主要目的是从试验工作人员的角度理解招募情况,并发现他们认为重要的因素。

方法

我们应用了多元民族志方法,包括分析试验文件、观察和焦点小组讨论,并探讨了EMPOWER(精神病早期症状监测以预防复发并促进幸福感、参与度和康复)可行性试验的招募过程,该试验是一款基于数字应用程序的针对被诊断为精神分裂症患者的干预措施。

结果

招募障碍分为两个主要主题:服务特征(心理健康工作人员缺乏支持招募的时间、人员流动、患者流动[仅在澳大利亚境内]、社区心理健康团队的管理方式以及物理环境)和临床医生期望(筛选效应和对研究参与的抵触)。试验工作人员通过诸如情感劳动(试验工作人员管理情绪和表达以成功招募参与者)以及试图与社区心理健康团队中的临床工作人员建立关系等策略来应对这些障碍。

结论

数字精神病干预临床试验的研究人员面临众多招募障碍,并尽力灵活应对这些障碍以实现招募目标。在试验的招募阶段,试验工作人员相互支持似乎增强了招募过程。

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