IMPlementation of A Relatives' Toolkit (IMPART study): an iterative case study to identify key factors impacting on the implementation of a web-based supported self-management intervention for relatives of people with psychosis or bipolar experiences in a National Health Service: a study protocol.

BACKGROUND: Web-based interventions to support people to manage long-term health conditions are available and effective but rarely used in clinical services. The aim of this study is to identify critical factors impacting on the implementation of an online supported self-management intervention for relatives of people with recent onset psychosis or bipolar disorder into routine clinical care and to use this information to inform an implementation plan to facilitate widespread use and inform wider implementation of digital health interventions. METHODS: A multiple case study design within six early intervention in psychosis (EIP) services in England, will be used to test and refine theory-driven hypotheses about factors impacting on implementation of the Relatives' Education And Coping Toolkit (REACT). Qualitative data including behavioural observation, document analysis, and in-depth interviews collected in the first two EIP services (wave 1) and analysed using framework analysis, combined with quantitative data describing levels of use by staff and relatives and impact on relatives' distress and wellbeing, will be used to identify factors impacting on implementation. Consultation via stakeholder workshops with staff and relatives and co-facilitated by relatives in the research team will inform development of an implementation plan to address these factors, which will be evaluated and refined in the four subsequent EIP services in waves 2 and 3. Transferability of the implementation plan to non-participating services will be explored. DISCUSSION: Observation of implementation in a real world clinical setting, across carefully sampled services, in real time provides a unique opportunity to understand factors impacting on implementation likely to be generalizable to other web-based interventions, as well as informing further development of implementation theories. However, there are inherent challenges in investigating implementation without influencing the process under observation. We outline our strategies to ensure our design is transparent, flexible, and responsive to the timescales and activities happening within each service whilst also meeting the aims of the project. TRIAL REGISTRATION: ISCTRN 16267685 (09/03/2016).

Protocol for an online randomised controlled trial to evaluate the clinical and cost-effectiveness of a peer-supported self-management intervention for relatives of people with psychosis or bipolar disorder: Relatives Education And Coping Toolkit (REACT).

INTRODUCTION: Despite clinical guidelines recommendations, many relatives of people with psychosis or bipolar disorder do not currently receive the support they need. Online information and support may offer a solution. METHODS AND ANALYSIS: This single-blind, parallel, online randomised controlled trial will determine clinical and cost-effectiveness of the Relatives Education And Coping Toolkit (REACT) (including an online resource directory (RD)), compared with RD only, for relatives of people with psychosis or bipolar disorder. Both groups continue to receive treatment as usual. Independent, web-based variable, block, individual randomisation will be used across 666 relatives. Primary outcome is distress at 24 weeks (measured by General Health Questionnaire; GHQ-28) compared between groups using analysis of covariance, adjusting for baseline score. Secondary clinical outcomes are carer well-being and support. Cost-effectiveness analysis will determine cost of a significant unit change (three-point reduction) in the GHQ-28. Costs include offering and supporting the intervention in the REACT arm, relevant healthcare care costs including health professional contacts, medications prescribed and time off (or ability to) work for the relative. Cost utility analysis will be calculated as the marginal cost of changes in quality-adjusted life years, based on EuroQol. We will explore relatives' beliefs, perceived coping and amount of REACT toolkit use as possible outcome mediators. We have embedded two methodological substudies in the protocol to determine the relative effectiveness of a low-value (£10) versus higher value (£20) incentive, and an unconditional versus conditional incentive, on improving follow-up rates. ETHICS AND DISSEMINATION: The trial has ethical approval from Lancaster National Research Ethics Service (NRES)Committee (15/NW/0732) and is overseen by an independent Data Monitoring and Ethics Committee and Trial Steering Committee. Protocol version 1.5 was approved on 9 January 2017. All updates to protocols are uploaded to the National Institute for Health Research (NIHR) Journals Library. A full statistical analysis plan is available at https://figshare.com/account/home#/projects/19975. Publications will be in peer-reviewed journals (open access wherever possible). Requests for access to the data at the end of the study will be reviewed and granted where appropriate by the Trial Management Group. TRIAL REGISTRATION NUMBER: ISRCTN72019945, pre-results.