Evaluation of intervention fidelity of a complex psychosocial intervention Lifestyle Matters: a randomised controlled trial
Evaluation of intervention fidelity of a complex psychosocial intervention Lifestyle Matters: a randomised controlled trial
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DOI：
10.1136/bmjopen-2020-043478
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发表时间：
2021-04-08
期刊：
影响因子：
2.9
通讯作者：
Craig C
中科院分区：
文献类型：
--
作者：
Sprange K;Mountain G;Craig C
需要对旨在促进晚年心理健康的复杂干预措施进行深入研究，为服务发展提供信息。一个重要组成部分是确保此类干预措施按预期实施。我们详细描述了在此类干预措施（生活方式问题）的试验中保真度评估的设计和实施。这些发现有助于解释试验结果，并为未来复杂干预措施评估中嵌入式保真度评估的设计提供信息。我们进行了混合方法保真度评估，作为多中心实用随机对照试验的一部分。概念保真度框架是根据行为改变联盟框架开发的。由此设计了保真度评估。由此产生的工具评估了以下参数：干预设计、培训、监督；干预措施的交付、接收和实施。生活方式问题干预旨在帮助老年人通过参与有意义的活动来改善和维持心理健康。目的是通过便利的小组会议和个人会议，使参与者能够参与新的和被忽视的活动。保真度评估表明，干预措施是按照小组组成部分的协议进行的，并且是根据个人需求量身定制的。评估者之间对培训达成了实质性一致；小组成员表现0.72；协调员表现的中等一致性为 0.55。无法确定引导者表现的小幅下降是由于引导者漂移还是由于群体动态或参与者特征等调节因素造成的。评估方法充分衡量了被确定为重要的保真度指标的标准。培训、交付和监督期间的遵守情况良好。识别和评估观察到的行为的主观性质是主要挑战。未来的研究应该探索评估复杂干预试验中保真度的替代方法。 ISRCTN67209155。
Robust research of complex interventions designed to promote mental well-being in later life is required to inform service development. An essential component is ensuring that such interventions are delivered as intended. We present a detailed description of the design and implementation of a fidelity assessment within a trial of one such intervention (Lifestyle Matters). The findings help to explain the trial results and also inform the design of embedded fidelity assessments within future evaluations of complex interventions. We conducted a mixed-method fidelity assessment embedded as part of a multicentre pragmatic randomised controlled trial. A conceptual fidelity framework was developed from the Behaviour Change Consortium framework. From this the fidelity assessment was designed. The resulting instrument assessed the following parameters: intervention design, training, supervision; and delivery, receipt and enactment of the intervention. The Lifestyle Matters intervention was designed to assist older people to improve and sustain mental well-being through participation in meaningful activity. The aim is to enable participants to engage in both new and neglected activities through a mix of facilitated group meetings and individual sessions. The fidelity assessment demonstrated that the intervention was delivered as per protocol for the group component and was tailored to meet individual needs. There was substantial inter-rater agreement for training; and group member performance 0.72; and moderate agreement for facilitator performance 0.55. It was not possible to determine whether small declines seen in facilitator performance were due to facilitator drift or moderating factors such as group dynamics or participant characteristics. The assessment methods adequately measured criteria identified as being significant indicators of fidelity. Adherence during training, delivery and supervision was good. The subjective nature of identification and rating observed behaviours was the main challenge. Future research should explore alternative methods of assessing fidelity in trials of complex interventions. ISRCTN67209155.
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