Title: Integrating pulmonary rehabilitation with early supported discharge services following hospitalised acute exacerbations of chronic obstructive pulmonary disease.
Funder: Health Education England

Abstract: BACKGROUND & RATIONALE Acute exacerbations of COPD (AECOPD) are one of the commonest causes of emergency department visits and hospital admission in the UK. Early supported discharge (ESD) services aim to shorten hospital length of stay by providing nursing-supervised medical treatment in patient's home in lieu of inpatient care. Systematic reviews have shown that ESD for selected patients with AECOPD is not associated with: 1) increased risk of mortality; 2) higher numbers of readmissions; or 3) elevated healthcare costs as compared with inpatient care. However there are still high risks of readmission for patients who receive ESD, ranging from 29-38% at three months. Pulmonary rehabilitation (PR) (a hospital or community-based multidisciplinary exercise-training and education programme) delivered in the peri-AECOPD setting leads to benefits in exercise capacity and health-related quality of life, and reduces hospital readmission. However less than 10% of hospitalised AECOPD patients' complete early PR, with travel a commonly cited barrier. Integrating PR within ESD may have synergistic benefits in the delivery of intermediate care for AECOPD. Expanding the remit of ESD to incorporate exercise-training and self-management education may: 1) enhance physical recovery and quality of life, and reduce hospital readmissions; 2) increase the uptake and adherence to supervised exercise-training through direct provision in the home setting; and 3) potentially provide a bridge to conventional outpatient-based PR. The aim is to explore the feasibility of integrating PR within an ESD scheme. INTERVENTION DEVELOPMENT Design: Accelerated experience-based co-design using an archive of video and audio recordings of hospitalised and post-discharge people with AECOPD, incorporating three focus events: 1) staff (members of inpatient, ESD and PR teams); 2) patients/carers; and 3) joint with patients-carers-staff. FEASIBILITY TESTING Design: A mixed methods MRC Phase II exploratory trial including: 1) a parallel group, randomised controlled, assessor-blinded feasibility trial with participants randomised (1:1) to the usual care or intervention group, with 3 month and 12 month follow-up; and 2) embedded qualitative interviews and focus groups. Participants: 80 adults with COPD, admitted to hospital with AECOPD, and accepted for ESD within 72 hours of hospital admission. Control (usual care): Nursing-focused ESD comprising of as required face-to-face 30 minute sessions (typically four to seven visits over 14 days) followed by a telephone follow-up 14 days after hospital discharge. Treatment includes: antibiotics; steroids; nebulisers; and provision of oxygen as required. Intervention: Usual care, plus additional supervised home-based exercise and education sessions following discharge from hospital. Embedded interviews/focus groups: In-depth topic-guided interviews with approximately 20 purposively sampled participants (patients/carers) and two focus groups with 10-15 staff, to explore experiences of the intervention, how the intervention impacted perceptions of outcome, acceptability of outcome measures and trial conduct. Feasibility outcomes: Patient flow (screening to follow-up); uptake of intervention; assessor blinding; completion rates, missing data, variances, difference and 95% confidence intervals between groups for clinical outcomes. Clinical outcomes: Short Physical Performance Battery; upper limb strength; dynamic balance test; questionnaire measures of activities of daily living; health-related quality of life; health utility; anxiety and depression; accelerometer-measured daily physical activity; mortality. Health resource usage: Hospital readmissions; bed days; healthcare professional visits. Statistical analysis: Baseline demographics, patient flow data and missing data summarised overall and by trial group; feasibility outcomes described and summarised using proportions (95% CIs) or means (SD, range); clinical outcomes and health resource usage described, effect sizes estimated, without inferential testing. ROUTE TO DEFINITIVE TRIAL The project will provide the tangible deliverables required to inform the MRC Phase III definitive 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 the most common lung condition in older adults. Many people with COPD suffer with breathlessness that often affects their everyday life and activities. Breathlessness gets worse during a COPD flare-up and these flare-ups can lead to an unplanned emergency hospital admission. People with COPD who are admitted to hospital with a flare-up may have Early Supported Discharge'. This means they receive the same medical treatment they would in hospital but they get it in their own home, with regular visits by a specialist nurse. Early Supported Discharge focuses on medical treatment but does not always address physical and mental issues resulting from a flare-up. These can include muscle weakness, difficulty exercising, a chesty cough and anxiety or panic attacks. One treatment that does address these physical and mental issues is Pulmonary Rehabilitation'. Pulmonary Rehabilitation consists of exercise and education, led by a physiotherapist. The classes are most often delivered at a hospital or community setting. Research studies show that Pulmonary Rehabilitation shortly after a COPD flare-up improves muscle strength, ability to exercise and quality of life. However patients often feel too unwell to travel to classes so only a small proportion of people who could benefit actually complete Pulmonary Rehabilitation. What is the aim of the research? We want to see whether it is possible to provide Pulmonary Rehabilitation at home within Early Supported Discharge. We want to know whether this combination is acceptable to patients, carers and healthcare staff. We will also explore if this combination can improve ability to exercise and do everyday activities as well as quality of life more than Early Supported Discharge alone. What is involved? There are three related studies. Study 1 looks at previous research to see what sort of home-based exercises have been helpful to patients with breathlessness or COPD. Study 2 will work out how best to run the combined Pulmonary Rehabilitation at home within Early Supported Discharge. For this, patients, carers and healthcare staff will meet to discuss the previous research, and decide who should deliver the programme, what exercise and education should be included, how often sessions should happen, and for how long sessions will last. Study 3 is a small-scale study for patients who have had a COPD flare-up and are suitable for Early Supported Discharge. These patients will receive either usual Early Supported Discharge or the newly combined programme that includes Pulmonary Rehabilitation at home. We will ask the patients, carers and healthcare staff involved about whether the new combined programme is acceptable and how it might be improved. Why is this important? COPD flare-ups are a very big healthcare problem. The NHS spends more than 1 billion on treating COPD. People with COPD, who have recently been in hospital with a flare-up, often have distressing breathlessness, muscle weakness, are not able to do their usual everyday activities, a chesty cough and anxiety. Understanding how best to support people with their recovery from a flare-up could have a big impact on patients' quality of life and ability to exercise. It could also reduce the risk of returning to hospital. What will happen to the results of this research? We will share the results of this research with other healthcare staff through presentations at local meetings and international conferences, social media, professional networks and papers in scientific journals. We will also share our results with local and national patient groups. The information gathered from this research will be used to help design a large-scale study in the future. This large-scale study will involve many more patients from different hospitals in different areas of the country. It will see whether this newly-combined programme (Pulmonary Rehabilitation at home within Early Supported Discharge) benefits patients, carers and the health service at an acceptable cost. How will patients and the public be involved? Patients and carers are central to the research. They will help design and develop the new combined programme, and those who try it out in the study will be interviewed to see how it could be improved. Two patients from the local patient support group will be active members of the trial steering group. This means giving advice on study documents including the protocol and patient information sheet, and working with us to overcome or resolve any study-related issues. They will be financially compensated for their time and acknowledged for all their input when the study results are shared.

Research activity codes: 6.7 PHYSICAL;7.1 INDIVIDUAL CARE NEEDS
Health categories: RESPIRATORY