Title: Improving life quality in chronic obstructive pulmonary disease (COPD) by increasing uptake and completion of pulmonary rehabilitation with lay health workers: a cluster randomised controlled trial
Funder: Department of Health and Social Care

Abstract: Chronic obstructive pulmonary disease (COPD) is the most common lung disease caused by smoking. It affects more than a million people in the UK. It causes breathlessness, cough, and fatigue. Flare-ups can lead to hospital admission. Pulmonary rehabilitation (PR) is the best treatment for the symptoms and impact of COPD. It improves quality of life and exercise capacity. PR classes include exercise and information on how to manage symptoms. More than 40,000 COPD patients are referred to PR each year in England, but the benefits of PR are limited by poor uptake. Only 4 out of 10 people with COPD, referred for PR, complete the classes. The reasons people don’t go include travel issues, low mood, uncertainty about its benefits, and shame about smoking._x000D_ _x000D_ Lay health workers (LHWs) are the key to this study. Our patient advisers call them ‘PR buddies’. COPD volunteers who have completed PR will be trained to be PR buddies. They will support patients referred for PR. We have shown in previous research that PR buddies/LHWs can be recruited and trained to support COPD patients referred for PR. LHWs were enthusiastic, committed volunteers, and patients welcomed their support. LHWs are effective in a range of health issues but they have not been used much in the NHS._x000D_ _x000D_ Aim_x000D_ We want to improve quality of life for people with COPD by increasing the number of patients completing PR._x000D_ We want to know if trained volunteer LHWs are effective, efficient and acceptable in improving PR completion. We also want to know if LHW training and setting up PR buddy provision can be incorporated into PR services. _x000D_ _x000D_ How we will do this_x000D_ We will develop and test a training package for PR staff to introduce PR buddies in their services. We will measure the impact of the PR buddies by counting the number of patients who complete a course of PR in 19 ‘LHW’ centres around England compared with 19 ‘usual care’ PR centres. LHWs will be trained in proven techniques (‘behaviour change techniques’) to find out why people might not go to PR. When patients get an appointment to start PR, they will be put in touch with an LHW. Contact will be by phone mainly but also by meeting up._x000D_ _x000D_ There will be five stages or work packages (WP) in this research trial._x000D_ WP1. Get ethical approval, develop PR staff training, prepare training manuals. Recruit PR services._x000D_ _x000D_ WP2. Test the training of PR staff and the running of a PR buddy service in two of 38 PR centres selected at random. This is called an internal pilot. An independent committee will decide if the trial should continue or be stopped depending on the results of the pilot._x000D_ _x000D_ WP3. Main trial. We will continue the trial of PR buddies in a further 17 PR centres selected at random. The results will be compared to 19 ‘usual care’ PR centres who will deliver PR as normal._x000D_ _x000D_ WP4. Each part of the trial will be evaluated, including PR staff training, PR buddy/LHW training and acceptability to patients, LHWs, and PR staff._x000D_ _x000D_ WP5. An economic evaluation._x000D_ _x000D_ The outcomes of WP 3,4, and 5 will help make a plan for roll-out in the NHS._x000D_ _x000D_ We have an active COPD patient advisory group. A member is a co-applicant. They helped with this application, this lay summary and will be involved throughout the research._x000D_ _x000D_ We will communicate our research findings through scientific meetings, regional PR networks, respiratory organisations, public meetings, a trial website, social media, press releases, and articles in scientific journals.

Lay abstract: Are trained volunteer lay health workers (LHWs) effective, efficient and acceptable in improving completion rates of NHS pulmonary rehabilitation (PR)?_x000D_ Can the LHW intervention be implemented by PR staff? _x000D_ _x000D_ Background_x000D_ Chronic obstructive pulmonary disease (COPD) is the most common lung disease caused by smoking. It affects more than a million people in the UK. COPD causes breathlessness, cough, and fatigue and exacerbations can lead to admission. PR is the best treatment for the symptoms and impact of COPD. It improves quality of life and exercise capacity. PR classes include exercise and self-management. More than 40,000 COPD patients are referred to PR each year in England, but the benefits are limited by poor uptake. Only 40% of people referred for PR complete it. The reasons why people don’t complete the treatment include travel issues, low mood, uncertainty about its benefits, and shame about smoking._x000D_ _x000D_ LHWs are at the core of this study. COPD volunteers who have completed PR will be trained as LHWs and will support patients referred for PR. We have shown, in a feasibility study, that LHWs can be recruited and trained to support these patients. LHWs were enthusiastic, committed volunteers, and patients welcomed their support. LHWs are effective in a range of health issues but have been little used in the NHS._x000D_ _x000D_ Aims and objectives_x000D_ To improve quality of life for people with COPD by increasing by 40% the number of referred patients completing PR with an LHW intervention._x000D_ To show that the training and management of LHWs can be incorporated into NHS PR services. _x000D_ _x000D_ Type of study_x000D_ Cluster randomised controlled clinical trial of impact of LHW intervention on completion rates in PR centres throughout England. PR centres (clusters) will be randomised to intervention (LHW + usual care) or control arms (usual care)._x000D_ _x000D_ Methods, Work Packages (WP) and Timelines for Delivery_x000D_ WP1. Trial set up - months 1-8: Develop a training package for PR staff to recruit, train and manage LHWs in their PR centres. Refine the LHW training and intervention developed in the feasibility study. Recruit PR centres for the trial. Assess the impact of COVID-19 on PR delivery._x000D_ WP2. Internal Pilot - months 9-16: Randomise four centres, two to intervention and two to control, to assess PR staff training and LHW intervention delivery. Present outcome of Stop-Go criteria: delivery fidelity; LHW retention; and impact of COVID-19 on trial integrity; to Independent Trial Steering Committee for decision on progression - month 17. _x000D_ WP3. Main trial – months 18 - 30: Continue trial in a further 34 PR centres, 17 intervention and 17 usual care. Principal outcome will be rate of completion in intervention sites compared to control sites. _x000D_ WP4. Process evaluation: Each element will be evaluated, including PR staff training, LHW training, intervention fidelity, and acceptability to patients, LHWs, and PR staff._x000D_ WP5. Health economic evaluation._x000D_ _x000D_ PPI involvement_x000D_ Our COPD advisory group of seven years, with our PPI co-applicant, has been closely involved in the intervention development and will be involved throughout the trial. _x000D_ Anticipated impact and dissemination_x000D_ The LHW intervention will enhance the delivery of PR, improve the efficiency of PR services and reduce waste._x000D_ The findings will be disseminated through public meetings, a trial website, charitable and professional associations, social media, Youtube video, press releases, and scientific publications.

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