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

Are trained volunteer lay health workers (LHWs) effective, efficient and acceptable in improving completion rates of NHS pulmonary rehabilitation (PR)? Can the LHW intervention be implemented by PR staff? Background 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. 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. Aims and objectives To improve quality of life for people with COPD by increasing by 40% the number of referred patients completing PR with an LHW intervention. To show that the training and management of LHWs can be incorporated into NHS PR services. Type of study 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). Methods, Work Packages (WP) and Timelines for Delivery 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. 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. 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. WP4. Process evaluation: Each element will be evaluated, including PR staff training, LHW training, intervention fidelity, and acceptability to patients, LHWs, and PR staff. WP5. Health economic evaluation. PPI involvement 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. Anticipated impact and dissemination The LHW intervention will enhance the delivery of PR, improve the efficiency of PR services and reduce waste. The findings will be disseminated through public meetings, a trial website, charitable and professional associations, social media, Youtube video, press releases, and scientific publications.