Rasmussen Charlotte Diana Nørregaard, Svendsen Malene Jagd, Wood Karen, Nicholl Barbara I, Mair Frances S, Sandal Louise Fleng, Mork Paul Jarle, Søgaard Karen, Bach Kerstin, Stochkendahl Mette Jensen
National Research Centre for the Working Environment, Copenhagen, Denmark.
Department of Sports Science and Clinical Biomechanics, University of Denmark, Odense M, Denmark.
JMIR Res Protoc. 2020 Oct 29;9(10):e20308. doi: 10.2196/20308.
Implementation and process evaluation is vital for understanding how interventions function in different settings, including if and why interventions have different effects or do not work at all.
This paper presents the protocol for an implementation and process evaluation embedded in a multicenter randomized controlled trial conducted in Denmark and Norway (the selfBACK project). selfBACK is a data-driven decision support system that provides participants with weekly self-management plans for low back pain. These plans are delivered through a smartphone app and tailored to individual participants by using case-based reasoning methodology. In the trial, we compare selfBACK in addition to usual care with usual care alone.
The aim of this study is to conduct a convergent mixed-methods implementation and process evaluation of the selfBACK app by following the reach, effectiveness, adoption, implementation, and maintenance framework. We will evaluate the process of implementing selfBACK and investigate how participants use the intervention in daily life. The evaluation will also cover the reach of the intervention, health care provider willingness to adopt it, and participant satisfaction with the intervention. We will gather quantitative measures by questionnaires and measures of data analytics on app use and perform a qualitative exploration of the implementation using semistructured interviews theoretically informed by normalization process theory. Data collection will be conducted between March 2019 and October 2020.
The trial opened for recruitment in February 2019. This mixed-methods implementation and evaluation study is embedded in the randomized controlled trial and will be collecting data from March 2019 to October 2020; dissemination of trial results is planned thereafter. The results from the process evaluation are expected 2021-2022.
This study will provide a detailed understanding of how self-management of low back pain can be improved and how a digital health intervention can be used as an add-on to usual care to support patients to self-manage their low back pain. We will provide knowledge that can be used to explore the possibilities of extending the generic components of the selfBACK system and key drivers that could be of use in other conditions and diseases where self-management is an essential prevention or treatment strategy.
ClinicalTrials.gov NCT03798288; https://www.clinicaltrials.gov/ct2/show/NCT03798288.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/20308.
实施与过程评估对于理解干预措施在不同环境中的作用至关重要，包括干预措施是否以及为何会产生不同效果或根本不起作用。
本文介绍了一项嵌入在丹麦和挪威进行的多中心随机对照试验（selfBACK项目）中的实施与过程评估方案。selfBACK是一个数据驱动的决策支持系统，为参与者提供针对腰痛的每周自我管理计划。这些计划通过智能手机应用程序提供，并使用基于案例的推理方法为个体参与者量身定制。在试验中，我们将selfBACK联合常规护理与单纯常规护理进行比较。
本研究的目的是遵循覆盖范围、有效性、采用率、实施情况和维持情况框架，对selfBACK应用程序进行收敛性混合方法实施与过程评估。我们将评估selfBACK的实施过程，并调查参与者在日常生活中如何使用该干预措施。评估还将涵盖干预措施的覆盖范围、医疗保健提供者采用它的意愿以及参与者对该干预措施的满意度。我们将通过问卷调查和应用程序使用情况的数据分析措施收集定量数据，并使用基于规范过程理论的半结构化访谈对实施情况进行定性探索。数据收集将于2019年3月至2020年10月进行。
该试验于2019年2月开始招募。这项混合方法实施与评估研究嵌入在随机对照试验中，将于2019年3月至2020年10月收集数据；之后计划公布试验结果。过程评估结果预计在2021 - 2022年得出。
本研究将详细了解如何改善腰痛的自我管理，以及如何将数字健康干预作为常规护理的补充，以支持患者自我管理腰痛。我们将提供可用于探索扩展selfBACK系统通用组件可能性的知识，以及可用于其他自我管理是重要预防或治疗策略的病症和疾病的关键驱动因素。
ClinicalTrials.gov NCT03798288；https://www.clinicaltrials.gov/ct2/show/NCT03798288。
国际注册报告标识符（IRRID）：DERR1 - 10.2196/20308。
