Abstract
BackgroundFrailty is characterised by increased vulnerability to falls, disability, hospitalisation and care home admission. However, it is relatively reversible in the early stages. Older people living with frailty often have multiple health and social issues which are difficult to address but could benefit from proactive, person-centred care. Personalised care planning aims to improve outcomes through better self-management, care coordination and access to community resources.MethodsThis feasibility cluster randomised controlled trial aims to recruit 400 participants from 11 general practice clusters across Bradford and Leeds in the north of England. Eligible patients will be aged over 65 with an electronic frailty index score of 0.21 (identified via their electronic health record), living in their own homes, without severe cognitive impairment and not in receipt of end of life care. After screening for eligible patients, a restricted 1:1 cluster-level randomisation will be used to allocate practices to the PROSPER intervention, which will be delivered over 12 weeks by a personal independence co-ordinator worker, or usual care. Following initial consent, participants will complete a baseline questionnaire in their own home including measures of health-related quality of life, activities of daily living, depression and health and social care resource use. Follow-up will be at six and 12 months. Feasibility outcomes relate to progression criteria based around recruitment, intervention delivery, retention and follow-up. An embedded process evaluation will contribute to iterative intervention optimisation and logic model development by examining staff training, intervention implementation and contextual factors influencing delivery and uptake of the intervention.DiscussionWhilst personalised care planning can improve outcomes in long-term conditions, implementation in routine settings is poor. We will evaluate the feasibility of conducting a cluster randomised controlled trial of personalised care planning in a community population based on frailty status. Key objectives will be to test fidelity of trial design, gather data to refine sample size calculation for the planned definitive trial, optimise data collection processes and optimise the intervention including training and delivery.Trial registrationISRCTN12363970 – 08/11/18.
Highlights
MethodsThis feasibility cluster randomised controlled trial aims to recruit 400 participants from 11 general practice clusters across Bradford and Leeds in the north of England
Frailty is characterised by increased vulnerability to falls, disability, hospitalisation and care home admission
We will evaluate the feasibility of conducting a cluster randomised controlled trial of personalised care planning in a community population based on frailty status
Summary
Trial design PROSPER is a multi-centre, two-arm, feasibility cluster RCT. A cluster is defined as a general practice or a group of practices where the practices share significant staff and/or services, or were due to merge during the trial period. Trial consent or assent Participant consent, recruitment and collection of baseline data will be undertaken in the potential participant’s own home by a researcher blind to cluster allocation. Consent to the process evaluation All participants will be recruited to the process evaluation by an independent researcher not involved in baseline or follow-up data collection for the feasibility trial. In addition to collecting primary data via non-participant observations, interviews and questionnaires, we will make use of secondary data sources wherever possible to reduce burden, i.e. CRFs from the trial and case reports from the Age UK delivery teams. Feasibility and acceptability of outcome measures and methods of data collection The number and proportion of participant completed data at baseline; 6- and 12-month follow-up will be reported by arm alongside completeness rates for individual measures. Harms In this patient population of older people with frailty, there is potential for acute illness resulting in hospitalisation, new medical problems and deterioration of
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