Use of a Personalised Early Warning Decision Support System for Acute Exacerbations of Chronic Obstructive Pulmonary Disease: Results of the "Predict & Prevent" Phase III Trial.

Abstract

Rationale: The Predict&Prevent trial was designed to provide a definitive randomised clinical trial of a personalised early warning decision support system, COPDPredict™.

Methods: Adults with ≥1 AECOPD were randomly assigned in a 1:1 ratio to use of a personalised early warning decision support system (COPDPredict™) 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).

Results: Ninety (11%) of 789 screened patients were enrolled. Admissions per participant due to AECOPD at 12 months was lower with COPDPredict™: Incidence rate ratio (IRR) 0.64 (95% CI 0.19-2.17, p = 0.478). Exploratory Bayesian analysis and sensitivity analyses saw similar results. No significant differences were seen in inpatient days, visits to accident and emergency visits, and number of exacerbations. COPD Assessment Test (CAT) score benefits occurred at 3 and 6 months with COPDPredict™ (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). There was not enough evidence to indicate a statistically significant treatment effect on the other outcomes.

Conclusions: COPDPredict™ failed to show a reduction in severe AECOPD events resulting in hospitalisations, although the number of admissions per participant was lower among users. The quality of life data (CAT scores) suggests that 6 months usage of COPDPredict™ period may be helpful to patients, with benefits exceeding the minimum clinically important difference throughout that time.

Trial registration: NCT04136418.