Remote-management of COPD: Evaluating Implementation of Digital Innovation to Enable Routine Care (RECEIVER) – Protocol for a feasibility and service adoption observational cohort study

Abstract IntroductionReduction in exacerbations and hospitalisations are the outcomes rated as most important by COPD patients. Patient self-management and evidence-based healthcare interventions that reduce exacerbations and hospital admissions do exist but there are considerable barriers to their uptake and delivery. Patient and clinician engagement is often not consistent. Data which could potentially predict exacerbations and treatment success are not acquired systematically and is not reliably visible or actionable at key time points of patient-clinician interaction. 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.We have developed a digital service model for COPD patients, designed to integrate current routine clinical care within a digitally enabled remote-monitoring service infrastructure. This digital platform will capture relevant routinely acquired patient-reported outcomes, continuous physiology data and clinical event/episode data in a patient and clinician co-designed interface. Methods and analysisThe remote management of COPD: evaluating implementation of digital innovations to enable routine care (RECEIVER) trial is a prospective observational cohort hybrid implementation and effectiveness study that will test the adoption of this 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.In our endpoints will determine patient engagement, clinical service impact and clinical outcomes that will be compared with historical and contemporary COPD control patient data, acquired from NHS GG&C SafeHaven. The digital innovations will be iterated throughout the study to optimize them, based on the user experience accrued. 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, for testing in future prospective clinical and regulatory trials through machine-learning analysis. Ethics and disseminationEthical 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. Key results will be presented at local, national and international meetings, including those with patient representation. All data obtained will be submitted for publication to peer reviewed journals. Trial registration numberNCT04240353