Clinical and Cost-effectiveness of Space for COPD © Delivered as a Maintenance Programme on Pulmonary Rehabilitation Discharge: A Randomised Controlled Trial

RATIONALE The benefits achieved during pulmonary rehabilitation (PR) are known to decline 6-12 months after the initial programme. There is no consensus on the best maintenance strategy. SPACE for COPD© (‘SPACE’: Self-management
Programme of Activity, Coping and Education for Chronic Obstructive Pulmonary Disease) has previously been shown to be effective. The aim and was to test SPACE as a maintenance programme in COPD.
METHODS We conducted a prospective, multicentre, single-blind randomised contro led trial. 116 COPD patients were randomised to usual care (control) or SPACE. The intervention was a home-based manual and 4x2hour sessions (face to face/telephone/online) adopting motivational interviewing over 12 months. Outcomes were colected at 6 and 12 months. Primary outcome: Endurance Shuttle Walking Test (ESWT) at 12 months. Secondary outcomes: maximal exercise capacity, health-related quality of life, mood, patient activation, physical
activity, intervention fidelity and intervention completion. A generalized linear mixed model was fitted. Missing data was imputed using a Bayesian framework. For cost effectiveness: NHS resource use, bottom-up costing for the maintenance programme, changes in Health Utility (EQ-5D-5L index) were recorded, analysed and differences compared to the level identified as significant for COPD.
RESULTS Baseline characteristics of the 2 groups were: control (51% male, aged 71.8 years, median MRC 3, mean FEV1/FVC ratio 56%, mean pack years 44.5, mean BMI 28.3) and SPACE (65% male, aged 71.8 years, median MRC 3, mean FEV1/FVC ratio 58%, mean pack years 41.1, mean BMI 29.1). 8 recruited were non-White British and 9 had home oxygen. There were some within group changes over time but no statisticaly significant differences between intervention and control groups for changes in the ESWT (figure 1) or secondary outcomes. The intervention group exhibited: (i)0.1178 advantage in mean QALY (Quality Adjusted Life Year) at 12 months (p<0.05), above the threshold for COPD significance and (ii)reduced NHS costs (predominately reduced GP visits). The intervention has a 97% chance of achieving £20,000 per QALY (NICE acceptance level ≤£30,000). Intervention fidelity was excellent (100% content delivered) and 83% of intervention participants completed 3/more sessions.
CONCLUSION Our economic findings confirm that a structured PR maintenance programme is cost-effective if not clinically effective. The programme had a focus on self-management and drove down GP costs in the intervention group. Future trials should look to replicate the self-management focus of the programme, delivered over a 12 month period.