Abstract
INTRODUCTION: Reductions in exacerbation and hospitalisations are the outcomes rated as most important by people with chronic obstructive pulmonary disease (COPD). Most COPD management is currently based on a reactive approach, and delays in recognising treatable opportunities underpin COPD care quality gaps. Innovations that empower COPD self-management, facilitate integrated clinical care and support delivery of evidence-based treatment interventions are urgently required. METHODS AND ANALYSIS: The Remote-Management of COPD: Evaluating the Implementation of Digital Innovation to Enable Routine Care trial is a prospective observational cohort hybrid implementation and effectiveness study that will explore the adoption of a digital service model for people with 'high-risk' COPD and evaluate the feasibility of this approach versus current standards of care. People with COPD, who have had recent severe exacerbation and/or COPD-obstructive sleep apnoea overlap or chronic hypercapnic respiratory failure requiring home non-invasive ventilation (NIV) or continuous positive airway pressure (CPAP), with internet access will be recruited into the study and enrolled into the digital service.Study endpoints will examine participant utilisation, clinical service impact and clinical outcomes compared with historical and contemporary control patient data. The digital infrastructure will also provide a foundation to explore the feasibility of approaches to predict outcomes and exacerbation in people with COPD through machine learning analysis. ETHICS AND DISSEMINATION: Ethical approval for this clinical trial has been obtained from the West of Scotland Research Ethics Service. The trial will commence in September 2019 for a duration of 2 years. Results will be presented at local, national and international meetings, as well as submission for publication to peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04240353.