An Implementation Trial to Improve Access to Pulmonary Rehabilitation in People With COPD (HomeBase2)

HomeBase2: An Implementation Trial to Improve Access to Pulmonary Rehabilitation in People With Chronic Obstructive Pulmonary Disease

Institute for Breathing and Sleep, Australia, University of Melbourne, La Trobe University, Thoracic Society of Australia and New Zealand, Lung Foundation Australia

People with chronic obstructive pulmonary disease (COPD) experience distressing breathlessness and high health care utilisation. There is compelling evidence that pulmonary rehabilitation improves symptoms and reduces hospitalisation, but is delivered to <10% of patients who would benefit. The investigators developed a low cost model of pulmonary rehabilitation that can be delivered entirely at home. The HomeBase model had equivalent outcomes to centre-based pulmonary rehabilitation in a phase II efficacy trial, with higher completion rates. The investigators hypothesise that a patient centred model offering a choice between home or centre-based pulmonary rehabilitation may increase program completion rates, with improved outcomes for patients and the health system. This is a cluster randomised implementation trial investigating whether offering a choice of home or centre-based pulmonary rehabilitation can reduce hospitalisation, improve pulmonary rehabilitation completion and enhance patient outcomes in people with COPD. 14 pulmonary rehabilitation programs located across Australia will each recruit 35 people with COPD. Intervention centres: People with COPD will be offered the choice of centre-based pulmonary rehabilitation or the HomeBase model. Comparison centres: Only the existing centre-based model will be offered. The primary outcome is all cause, non-elective hospitalisation at 12 months. Other outcomes are symptoms, exercise capacity and quality of life at 8 weeks and 12 months; and health care costs at 12 months for full economic evaluation.

Participants will be informed that the trial is assessing the impact of pulmonary rehabilitation models on patient and health system outcomes, but not the specific nature of the models of interest, or the intervention group to which their site has been allocated. Assessors will be blinded to the site allocation.

Pulmonary rehabilitation programs assigned to the intervention group will offer eligible participants the choice of participating in an 8-week program of either home-based pulmonary rehabilitation or traditional centre-based pulmonary rehabilitation.

Pulmonary rehabilitation programs assigned to the control group will offer eligible participants the opportunity to participate in an 8-week centre-based pulmonary rehabilitation program, as per current practice.

Participants will be offered the choice of HomeBase, a home-based pulmonary rehabilitation program, or the traditional centre-based pulmonary rehabilitation program.

Disease-specific health-related quality of life measure; scores range 1-7, higher scores indicate better health-related quality of life

Generic health-related quality of life measure to inform economic analysis; 5 dimensions each scored 1-5 with lower values indicating better health-related quality of life

Global measure of breathlessness; total scores range from 0 to 36, with higher scores corresponding to greater severity of dyspnoea

Health care costs in Australian dollars will be calculated using health care utilisation data including hospitalisation, primary care visits and medication use

The number of participants who complete their allocated rehabilitation program (attend at least 70% of planned sessions).

Inclusion criteria for pulmonary rehabilitation programs: • Outpatient pulmonary rehabilitation programs that admit at least 50 people with COPD each year. Inclusion criteria for participants: Diagnosis of COPD confirmed on spirometry Able to read, write and speak English Able to provide informed consent. Exclusion Criteria: Attended pulmonary rehabilitation within 1 year Comorbidities which preclude exercise training.

The investigators will make individual participant data available to other researchers for related projects with appropriate ethical oversight. The data provided would be in re-identifiable form with no identifying information provided. Access will only be granted to researchers who agree to preserve the confidentiality of the information. Access will require approval from the research team as well as approval from a Human Research Ethics Committee.

Access will only be granted to researchers who agree to preserve the confidentiality of the information. Access will require approval from the research team as well as approval from a Human Research Ethics Committee

Holland AE, Jones AW, Mahal A, Lannin NA, Cox N, Hepworth G, O'Halloran P, McDonald CF. Implementing a choice of pulmonary rehabilitation models in chronic obstructive pulmonary disease (HomeBase2 trial): protocol for a cluster randomised controlled trial. BMJ Open. 2022 Apr 11;12(4):e057311. doi: 10.1136/bmjopen-2021-057311.