Improving Wellbeing and Health for Care Home Residents During COVID-19

Summary

Participation Requirements

Description

COVID E-WHELD: E?ectiveness and Cost-E?ectiveness COVID-19 adapted WHELD (with digital resources and virtual coaching) will be compared to usual care in a 4 month randomized, parallel group, cluster RCT with 1280 care homes (allowing for 75% drop out because of COVID-19 outbreaks). Care homes will b...

COVID E-WHELD: E?ectiveness and Cost-E?ectiveness COVID-19 adapted WHELD (with digital resources and virtual coaching) will be compared to usual care in a 4 month randomized, parallel group, cluster RCT with 1280 care homes (allowing for 75% drop out because of COVID-19 outbreaks). Care homes will be randomly assigned to WHELD or treatment as usual in a 1:1 ratio. All care homes receiving treatment as usual will be offered the WHELD intervention after 4 months. Recruitment will build upon a number of networks and contacts. The investigators already have a network of more than 1300 care homes who would be our ?rst point of contact (100 additional care homes from Biomedical Research Centre (BRC) care home network. The investigators have a long established and successful record of recruiting large numbers of care homes to clinical trials (WHELD programme, FITS programme, Pimavanserin programme which involved more than 160 care homes). Evaluation will be undertaken at baseline, 4 weeks and 4 months post-baseline. The primary outcome measure will be quality of life in care home residents at 4 months, measured by the DEMQOL proxy, which has shown signi?cant bene?ts in previous WHELD RCTs. The secondary outcomes will include cost-e?ectiveness (EQ-5D), health utilization, use of sedative medications (anti psychotics, hypnotics), neuropsychiatric symptoms, sta? con?dence (CODE), staff self-e?cacy (SCIDS) and staff mental health (PHQ9) and a COVID-19 tracker. Process measures collected by coaches will include Goal Attainment, Assessments will be conducted by telephone or Microsoft Teams, by trained Research Assistants, or with the added option of being collected digitally for staff self-report measures. Data will also be collected on numbers of remote health and social care (HSC) consultations and on unplanned hospital attendances/admissions (including fall-related injuries). Researchers will also fully cost the COVID eWHELD intervention. To examine the opportunity costs of the intervention, champions will be asked to identify activities that were not undertaken in order to participate and to report any paid and unpaid overtime related to time spent in the champion role. Unit costs will be obtained from nationally applicable sources (PSSRU UC, NHS Reference costs) or calculated anew where necessary. Key elements of the WHELD intervention include: Coaching/training to deliver the WHELD programme which includes person-centred care and person-centred activities and person-centred care plans. A COVID-19 speci?c resource toolkit - digital bite-sized practical content to stay connected, develop new routines, how to respond to virus-related fear and anxiety Facilitated online peer support network for care home managers to share stories and solutions for COVID-19 challenges Pooling insights from others to create short, digestible digital resources, such as: checklists, video tips, one-page guides, do's and don'ts, infographics, etc. Providing communal, collaborative online group supervision calls, to promote sta? well-being and peer-to-peer communities in an online gathering place Developing easy reference guides to enable sta? to support residents, where appropriate, to use virtual communication tools to stay connected with family and friends Providing a series of suggestions, activities, and games all designed to foster connection during a time of isolation As the intervention is optimized best practice, the researchers would consider this activity as service delivery and not research. The research element is the evaluation of potential benefits for residents and staff, and the evaluation of cost-effectiveness. Analyses and reporting will follow CONSORT guidance. A full statical analysis plan will be developed during the initial phases of the project and signed o? prior to database lock. The UK Clinical Research Collaboration (UKCRC)-registered Exeter Clinical Trials Unit will be fully involved in the design, management and governance of the RCT aspects of the trial. The unit will have input into the methodology, provide central trial management/senior oversight, build and test the required data collection systems, undertake randomization, manage the data and ensure a surrounding quality assurance framework. Care homes will specifically be able to pause participation in the study if there is a COVID-19 outbreak in the care home.

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