Manchester Academic Health Science Centre, The University of Manchester, Manchester, England.
Greater Manchester Mental Health NHS Foundation Trust, The University of Manchester, Manchester, England.
Brain Behav. 2021 Dec;11(12):e2436. doi: 10.1002/brb3.2436. Epub 2021 Nov 13.
A key challenge in delivering pragmatic trials of complex interventions is effective implementation within the study period and beyond. We describe a trial of an intervention to improve quality of life in mild dementia (Journeying through Dementia), describe some of the challenges raised in terms of implementation, and illustrate the methods used to ensure effective implementation.
The intervention was delivered by staff within local services and supervised by more experienced clinicians within those services in order to test the intervention in real-world settings and establish the potential for future embedding into practice. Researchers delivered training sessions for all facilitators and supervisors, met at regular intervals with intervention supervisors, and provided feedback on summaries of intervention sessions created by facilitators. We conducted a thematic analysis of the content of meetings and written correspondence between the researchers and intervention supervisors regarding implementation issues.
Key themes relating to difficulties with implementation were: staff absences and staff leaving posts; participant lack of engagement with intervention; difficulties with delivery of supervision; difficult group dynamics; lack of time to deliver the intervention; and lack of adherence to the intervention and its ethos.
We provide guidance for researchers involved in the trialing of other complex interventions in how these challenges might be overcome. These include: recruiting additional staff to deliver the intervention; having clear protocols in place for managing staff absences; using supervision to problem solve participant attendance at intervention sessions and difficult group dynamics; monitoring staff engagement in supervision and addressing problems with engagement with staff and managers when this occurs; giving staff ring-fenced time to deliver the intervention and engage in supervision; and regular monitoring and feedback in relation to the content of the intervention to ensure that it is consistent with ethos and content of the intervention manual.
在进行复杂干预措施的实用试验中，一个关键挑战是在研究期间及之后有效地实施。我们描述了一项旨在改善轻度痴呆患者生活质量的干预措施的试验（Journeying through Dementia），描述了在实施方面提出的一些挑战，并说明了确保有效实施的方法。
该干预措施由当地服务机构的工作人员提供，并由这些服务机构中的经验丰富的临床医生进行监督，以便在真实环境中测试干预措施，并确定未来将其纳入实践的潜力。研究人员为所有协调员和监督者提供了培训课程，定期与干预监督者会面，并为协调员创建的干预会议摘要提供反馈。我们对研究人员和干预监督者之间关于实施问题的会议内容和书面通信进行了主题分析。
与实施困难相关的主要主题包括：工作人员缺勤和离职；参与者对干预措施缺乏参与；监督交付困难；小组动态困难；缺乏时间提供干预措施；以及缺乏对干预措施及其精神的坚持。
我们为参与其他复杂干预措施试验的研究人员提供了指导，说明如何克服这些挑战。这些包括：招聘额外的工作人员来提供干预措施；制定明确的协议来管理工作人员的缺勤；利用监督来解决参与者参加干预会议和小组动态困难的问题；监测工作人员在监督中的参与情况，并在出现问题时与工作人员和管理人员解决问题；为工作人员提供专门用于提供干预措施和参与监督的时间；并定期监测和反馈干预措施的内容，以确保其与干预手册的精神和内容一致。
