Phase III, two arm, multi-centre, open label, parallel-group randomised designed clinical investigation of the use of a personalised early warning decision support system to predict and prevent acute exacerbations of chronic obstructive pulmonary disease: 'Predict & Prevent AECOPD' - study protocol.

Introduction: With 65 million cases globally, chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death and imposes a heavy burden on patients' lives and healthcare resources worldwide. Around half of all patients with COPD have frequent (≥2 per year) acute exacerbations of COPD (AECOPD). Rapid readmissions are also common. Exacerbations impact significantly on COPD outcomes, causing significant lung function decline. Prompt exacerbation management optimises recovery and delays the time to the next acute episode.
Methods/analysis: The Predict & Prevent AECOPD trial is a phase III, two arm, multi-centre, open label, parallel-group individually randomised clinical trial investigating the use of a personalised early warning decision support system (COPDPredict) to predict and prevent AECOPD. We aim to recruit 384 participants and randomise each individual in a 1:1 ratio to either standard self-management plans with rescue medication (RM) (control arm) or COPDPredict with RM (intervention arm).The trial will inform the future standard of care regarding management of exacerbations in COPD patients. The main outcome measure is to provide further validation, as compared with usual care, for the clinical effectiveness of COPDPredict to help guide and support COPD patients and their respective clinical teams in identifying exacerbations early, with an aim to reduce the total number of AECOPD-induced hospital admissions in the 12 months following each patient's randomisation.
Ethics and Dissemination: This study protocol is reported in accordance with the guidance set out in the Standard Protocol Items: Recommendations for Interventional Trials statement. Predict & Prevent AECOPD has obtained ethical approval in England (19/LO/1939). On completion of the trial and publication of results a lay findings summary will be disseminated to trial participants.
Trial Registration Number: NCT04136418.
Competing Interests: Competing interests: The CI of the trial (AMT) does not have any relevant direct financial disclosures, nor do members of the Trial Management Group (TMG) who are authors of this paper, with the exception of NP who is a founder, director and shareholder of NEPeSMO, who developed the intervention. In addition, MS is CI of the overall NIHR-funded project and is a founder, director and shareholder of NEPeSMO. NEPeSMO is a start-up company from the University Hospitals of North Midlands NHS Trust, owns all intellectual property rights of COPDPredict and is a project collaborator on the grant. AMT has grants from pharmaceutical companies working in the area of COPD (Chiesi, AstraZeneca) and has conducted advisory work for such (Boehringer, CSL Behring) but not in the area of medical devices or admission prevention. Neither has she worked for, or received monies from, any company working on admission prevention in the last 3 years.
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