Introduction: Reduction in exacerbations and hospitalisations are the outcomes rated as most important by COPD patients. Most COPD management is currently based on a reactive approach, and delays in recognising treatable opportunities underpin COPD care-quality gaps. Innovations which can empower patient self-management, facilitate integrated clinical care and support delivery of evidence-based treatment interventions are urgently required.
Methods and analysis: The RECEIVER trial is a prospective observational cohort hybrid implementation and effectiveness study that will test the adoption of a digital service model for "high-risk" COPD patients and evaluate the performance of this approach versus current standards of care. Patients with a recent severe exacerbation and/or COPD-OSA overlap or chronic hypercapnic respiratory failure requiring home NIV or CPAP, with access to smartphone, tablet or computer will be recruited into the study and enrolled into the digital service.
Study endpoints will examine patient utilisation, clinical service impact and clinical outcomes compared to historical and contemporary COPD control patient data. The digital infrastructure for this support of routine clinical care will also provide a foundation to explore the feasibility of approaches to predict outcomes and exacerbations in COPD patients through machine-learning analysis.
Ethics and dissemination: Ethical approval for this clinical trial has been obtained from the West of Scotland Research Ethics Service (WoSRES). 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