Title: Personalised care planning to improve quality of life for older people with frailty
Funder: Department of Health and Social Care

Abstract: Aims The overarching aim is to establish whether personalised care planning (PCP) for older people with frailty improves quality of life and reduces health and social care resource use at 12 months. Research questions How should PCP be targeted and resource use modelled across the frailty spectrum? How should PCP be optimised for older people with frailty? Is it feasible to conduct a cluster randomised controlled trial to evaluate PCP? Does PCP for older people with frailty improve quality of life and reduce health and social care resource use? Background and rationale Care for older people with frailty should be proactive and person-centred rather than reactive and disease focused. Personalised care planning (PCP) is a promising way to achieve this necessary shift. Age UK have developed an integrated care service to provide PCP in frailty, but the intervention has not yet been optimised and lacks rigorous evidence of effectiveness. We have developed, validated and implemented an electronic frailty index (eFI) that uses routinely available primary care data to identify the presence and severity of frailty in older people as the necessary first step in providing PCP. Research plan We propose to refine the target population for PCP using the eFI, and optimise PCP by evaluating the Age UK integrated care service against the underlying intervention theory. Following feasibility testing, we plan to evaluate the clinical and cost-effectiveness of the optimised PCP intervention in a definitive cluster RCT. WP1: Refining the target population by exploring resource use and quality of life in frailty We will use the eFI to investigate health and social care resource and quality of life data to refine the target population for PCP. We will analyse data from participants in the English Longitudinal Study of Ageing (ELSA), the Community Ageing Research 75+ (CARE 75+) study and the ResearchOne database, and use quality of life data from CARE 75+ to refine the target population, model resource use and develop a decision-analytic model. WP2: Optimising PCP for older people with frailty We will draw on social cognitive theory as the basis for intervention optimisation. We will review existing literature and conduct a detailed case study in up to four existing Age UK pilot sites to explore content and delivery of PCP using a combination of qualitative methods. We will establish an Intervention Development Group to enable iterative intervention optimisation and develop an implementation process for testing and refinement in WP3. We will use the NIH Behaviour Change Consortium framework to enhance intervention fidelity. WP3: Feasibility study We will establish feasibility of a cluster RCT evaluation of PCP for older people with frailty. We will use eFI cutpoints established in WP1 to identify 400 study participants across eight general practices randomised to deliver PCP or usual care. We will: establish recruitment/follow-up rates; feasibility/acceptability of proposed outcome measures; optimise data collection processes; refine the definitive trial sample size calculation. We will assess trial progression criteria at 12 months for: recruitment; intervention delivery; and follow-up. We will continue intervention optimisation in the feasibility study. WP4: Definitive trial Multicentre cluster RCT evaluating clinical and cost-effectiveness of PCP for older people with frailty, identified using the eFI, including health economic evaluation and parallel process evaluation. Outcomes collected at baseline, six and 12 months. Co-primary outcomes: Physical component summary (PCS) and mental component summary (MCS) scores of the SF36 as a measure of health-related quality of life at 12 months. Sample size: 20 general practices per arm, each recruiting 50 patients (2,000 participants in total), will provide 90% power at the 2.5% significance level (overall Type I error=0.05) to detect an MCID of 3 points for PCS and 4 points for MCS. Key secondary outcomes: Hospitalisation Care home admission Other secondary outcomes: Self-management ability (self-management ability scale, short version) Instrumental activities of daily living (NEADL) Loneliness (6-item De-Jong Gierveld scale) Carer quality of life (EQ5D-5L/Carer QoL) Cost-effectiveness: Within-trial and longer-term cost-effectiveness analysis from health and social care perspective, with ICERs using QALYs derived from EQ5D-5L. Process evaluation: Parallel mixed-methods process evaluation combining a qualitatively-driven evaluation of four additional sites outside the trial with analysis of quantitative data from all definitive trial sites, including investigation of the relationship between intervention moderators, mediators and outcomes. Projected outputs and dissemination plan Robust evidence on the clinical and cost-effectiveness of an optimised PCP intervention, suitably targeted for older people with frailty. A common framework for routine NHS delivery. Information for policy-makers and commissioners on wider NHS implementation. The dissemination strategy will include: a website; newsletters; social media. Results will be disseminated through lay, professional and commissioning forums. Benefits to patients and the NHS A successful PCP intervention to improve quality of life in older age and reduce use of NHS and adult social care services amongst core users has potential for considerable impact at an individual and societal level.

Lay abstract: Frailty is a condition of increased vulnerability to major changes in health as a result of seemingly small problems, such as an infection or new medication. It is common in older age, affecting around 10% of people aged over 65, and develops because as we get older our bodies change and can lose their inbuilt reserves, for example we lose muscle strength. People with frailty are at increased risk of falls, disability, loneliness, hospitalisation and care home admission. These problems can reduce quality of life and are costly for the NHS and social care. Our planned research programme will test whether personalised care planning (PCP) can improve quality of life for older people with frailty, and reduce health and social care costs. PCP uses a series of discussions between a patient and a trained individual to clarify goals, options and preferences and develop an agreed plan of action that is written down in a personalised care plan. Age UK have developed a model for PCP which we will study in detail and then test, with the aim of improving quality of life in older age. We plan four studies: Study 1: We have developed a tool that uses routine GP data to identify older people with frailty. In our first study, we will use the frailty tool and study research databases to find out how likely people with frailty are to use GP and hospital services, how much care they need, and how quality of life is affected in frailty. We will use this information to more accurately identify those who might benefit from PCP. Study 2: We have developed an initial idea of how PCP in frailty might work. We will use this initial idea to improve the Age UK integrated care service, which provides PCP for people with frailty. We will observe PCP in practice, interview older people and staff, and compare findings at different locations. This will help ensure that we can make any local changes that might be needed. Study 3: We plan a study to find out if it is possible to run a large trial of PCP for older people with frailty. We will use the findings from study 1 to find suitable older people with frailty and the findings from study 2 to provide PCP. We will recruit older people with frailty at two sites (Bradford and York) and collect information necessary to design a large trial and further improve PCP. Study 4: If study 3 is successful, we will run a large trial across Yorkshire and Greater Manchester to find out if PCP for older people with frailty can improve quality of life and reduce use of health and social care services.

Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES;7.1 INDIVIDUAL CARE NEEDS
Health categories: GENERIC HEALTH RELEVANCE