Abstract
Rationale Gold standard treatment for chronic obstructive pulmonary disease (COPD) includes a supported self-management plan to enable patients to recognise and treat acute exacerbations (AECOPD). The Predict & Prevent trial was designed to provide a definitive randomised clinical trial of a personalised early warning decision support system, COPDPredictTM.
Methods Adults with ≥1 AECOPD or COPD admission were randomly assigned in a 1:1 ratio to use of a personalised early warning decision support system (COPDPredictTM) or standard self-management plans with rescue medication (RM) (control). The primary outcome was number of hospital admissions for AECOPD at 12 months post-randomisation (intention to treat). Quality of life and healthcare utilisation were also assessed.
Results 789 patients were screened, of whom 90 were enrolled. Hospital admissions due to AECOPD at 12 months were lower with COPDPredictTM: Incidence rate ratio (IRR) 0.64 (95% CI 0.19 to 2.17) albeit with insufficient evidence of a treatment effect (p=0.48). Exploratory Bayesian analysis and sensitivity analyses saw similar results. No significant differences were seen in inpatient days, visits to accident & emergency visits, and number of exacerbations. COPD Assessment Test (CAT) score benefits occurred at 3 and 6 months with COPDPredictTM (adjusted mean difference -3.8 points, 95% confidence interval (CI) -6.3 to -1.2, p=0.004 and -3.0 points, 95% CI -5.7 to -0.4, p=0.025 respectively) but was non-significant at longer periods (p>0.22), though this could be observed by chance as indicated by the time-point by treatment interaction (p=0.269). There was not enough evidence to indicate a statistically significant treatment effect on the other outcomes
Conclusions The quality of life data (CAT scores) suggests that 6 months usage of COPDPredictTM period may be helpful to patients, with benefits exceeding the minimum clinically difference throughout that time.
Trial registration: NCT04136418