Title: Developing 'frailty fit' pulmonary rehabilitation services for people with chronic obstructive pulmonary disease
Funder: Department of Health and Social Care

Abstract: BACKGROUND & AIMAs a disease of older people, chronic obstructive pulmonary disease (COPD) prevalence and burden is increasing, despite falling rates in smoking. Patients living with COPD and frailty are among the most burdened and disadvantaged, with reduced odds of receiving disease-modifying treatments. Frail patients have over twice the odds of not completing pulmonary rehabilitation (PR); an international standard of care incorporating group-based exercise and education. The gold standard to manage frailty is through a Comprehensive Geriatric Assessment (CGA) including multidimensional review, individual recommendations and a geriatrician-led care plan. Despite frailty affecting 1 in 4 people with COPD, CGAs or models integrating geriatric services have yet to be tested. This project aims to develop then assess the feasibility of frailty fit' PR services that include CGAs on enrolment, and home delivery of PR components as required. Objectives seek to (i) develop the intervention and trial, (ii) determine feasibility of and optimise intervention, and (iii) determine feasibility and model a definitive trial.INTERVENTION & TRIAL DEVELOPMENTDesign: Qualitative interviews and stakeholder workshops Participants: Interviews: 20 patients with COPD, referred for PR, frail by Fried's model.Purposive sampling by age, living status, level of frailty, and completion of PR. Workshops: 25-30 patients as above, families, service providers, commissioners and voluntary sector representatives. Methods: Semi-structured interview schedule concerning: current health and function; services currently accessed; concerns and how these are addressed; and experience of PR. Following transcription and inductive thematic analysis, findings will be presented in a workshop and Transparent Expert Consultation used to produce recommendations for modifications to the feasibility trial. Structured groups will be facilitated to focus on (i) intervention focus, delivery, and training requirements; (ii) optimising acceptability to the target population; and (iii) trial processes and outcome measures.FEASIBILITY TESTINGDesign: Parallel group, randomised, controlled, multicentre feasibility trial. Participants randomised (1:1) to usual care or intervention over 8 weeks, with 6-month follow up and embedded qualitative interviews. Participants: 80 adults with COPD, referred for PR, frail by Fried's model, and without contra-indication to exercise, predominant neurological limitation to mobility, or receiving specialist geriatric services. Control (usual care): 8-week outpatient PR programme, comprising two supervised sessions of exercise and multidisciplinary education, and at least one additional home-based exercise session each week. Intervention: Usual care, plus (i) a geriatrician-led CGA at the point of enrolment, individual recommendations and a care plan actioned either by the geriatrician, local geriatric nursing team, or PR team; and (ii) home delivery of remaining PR components if unable to complete group-based PR, with telephone/multimedia support. Embedded interviews: In-depth semi-structured interviews in 20 participants allocated to intervention, to explore experience of the trial, both negative and positive, and how the intervention impacted on their perceptions of outcome. Feasibility outcomes: Patient flow (screening through to follow-up); assessor blinding; number and type of CGA recommendations (timescale to implement, compliance and contamination); PR uptake, adherence and completion; clinical outcome completion, missing data, variances, and between-group differences. Clinical outcomes: Short Physical Performance Battery, skeletal muscle mass and strength, activities of daily living, Hospital Anxiety and Depression Scale, Chronic Respiratory Questionnaire, Euro-QoL 5D-5L, and cost via Client Service Receipt Inventory. Statistical analysis: Baseline demographics, patient flow data, and missing data summarised overall and by site. Feasibility outcomes described and summarised using proportions (95% CIs) or means (SD, range). NHS, voluntary and societal cost estimates generated. Clinical outcomes described, effect sizes estimated, without inferential testing. ROUTE TO DEFINITIVE TRIALThe project will provide tangible deliverables required to inform a definitive effectiveness trial including: a full theoretical model; optimised intervention manual and training package; definitive trial protocol including primary outcome, and sample size requirements.

Lay abstract: What is the background to this research?Chronic obstructive pulmonary disease (COPD) is a common lung disease in older people, which causes breathing difficulties and affects day-to-day health. Despite the number of cigarette smokers falling, the number of people with COPD is growing. The best approach to help people manage their COPD includes providing a group exercise and education programme called pulmonary rehabilitation (PR). PR can reduce how breathless people are, improve their ability to exercise, and improve their quality of life. Unfortunately, not every person with COPD is able to complete and benefit from PR. In past research, we showed that about 1 in 4 people coming to PR services are frail' (for example, they walk slowly, have weak muscles, and struggle with day-to-day tasks). These people have a particularly difficult time completing PR. They are less than half as likely to complete a programme compared those who are not frail.What is our aim?In this project, we will develop and then test a new frailty fit' PR service. This service aims to help people living with frailty to stay active and independent, engage in PR, and manage their COPD. The new service will include professionals from healthcare for older people (geriatrics) who are expert at helping people with frailty. These professionals will provide a comprehensive review (like an MOT for your car), and an individual care plan to help each person living with frailty get in the best possible shape as they start a PR programme. If a person still encounters difficulties and is unable to complete PR as part of a group, the remaining exercise and education will be delivered in their home.What will we do?First, we will develop the service by learning from people currently living with COPD and frailty starting PR. We will interview 20 people to find out about their health and concerns, which healthcare professionals they see, and their experiences of PR (both good and bad). We will then invite 25-30 patients, families, healthcare professionals and/or service planners to a workshop' event. We will present the interview findings and our plans for the new service. Next, we will ask people attending to discuss several areas, including: what the new service should look like; how it to make it most accessible; and how we can know if it helps people.Second, we will test the service in a feasibility trial. This will help us to understand if the service can be delivered in practice, and how best we can evaluate it in real-life conditions. Since this is a new service, we are more interested in understanding whether the service design is right, rather than whether it provides added benefit. 80 people living with COPD and frailty will take part. They will be allocated by chance to either receive usual care or the new service. We will learn how many people enter and complete the trial, and if it is acceptable to allocate some people to receive the new service and others to usual care. For those people who are allocated to receive the new service, we also want to understand: what recommendations professionals make to help them take part in PR; what change are made to their care as a result of the recommendations; and if these changes help people with COPD and frailty to complete, and benefit from, PR. Why is this research important?This project brings together two healthcare specialities (respiratory and care of older people) and two effective treatments (PR and comprehensive reviews) into a new service for people living with COPD and frailty. This group are at high risk of becoming more unwell, losing their independence, and admitted to hospital or a care home. They are also disadvantaged as they are often unable to complete current PR services, which can improve health and well-being, and may reduce future healthcare costs. By supporting people with COPD and frailty to complete PR, this project should help to unlock these benefits for them. Even a small change has the potential to make big improvements as COPD is common and frailty is strongly linked to poor health outcomes. The new service may also help shape care for other people living with frailty, which is particularly important with our growing, ageing population.

Research activity codes: 6.7 PHYSICAL;8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: RESPIRATORY