Table 1

RECEIVER primary and secondary endpoints

Primary endpointProportion of enrolled high-risk participants with COPD who use remote management in a digital service model
Secondary endpointsClinical outcomes, comparing impact of digitally enabled remote management versus historical and contemporary SafeHaven cohorts:
  • Clinical events: COPD exacerbation; unscheduled care contact (digital platform, COPD team visit, primary care, emergency department, hospital admission); mortality—COPD and non-COPD related.

  • Hospital occupied bed days preceding and subsequent 12 months (adjusted time interval if survival <12 months).

  • Treatment uptake (where indicated): smoking cessation; pulmonary rehabilitation; vaccination; supported self-management; home oxygen; home NIV.

  • NIV group: NIV usage, symptom change, NIV therapy parameters, blood gases during routine clinical care.

  • Supported self-management: utilisation of self-management information (page views), number of exacerbation managed at home versus in hospital, number of rescue packs used in 12 months (captured through weekly PROs), utilisation of messaging (number of message threads), sputum microbiology (where available during routine clinical care), impact of patient activation measures (where measured during routine care).

  • Impact of demographics, physiology and patient activation measures (where measured during routine care)—deprivation category of area of residence, age and sex, number of previous admissions, smoking status, participation in pulmonary rehabilitation in previous 2 years; lung function measurements, modelled home air pollution exposure; EMG, oscillometry and home air pollution monitoring in subset of participants where this is carried out—on outcomes, clinical events and treatment uptake.


Clinical service outcomes for digital service model, remote-managed home NIV and supported self-management:
  • Remote-managed home NIV: number, nature and complexity of NIV therapy reviews and interventions to provide.

  • Supported self-management: number, nature and complexity of reviews and interventions to provide.

  • Digitalised service model: user and developer time/cost required for development and modification of clinical dashboard; qualitative analysis (clinical user satisfaction and reflection on efficiency or additional workload); quantitative analysis (clinical dashboard utilisation tracking).

  • Patient portal: user and developer time/cost required for development and modification of clinical dashboard; qualitative analysis (user satisfaction) and quantitative analysis (uptake, engagement with app and wearable, successful use of digital service vs bypass to conventional healthcare contacts).


Machine learning-supported exploratory analyses of associations and relative predictive importance of electronic health record, PROs, wearable physiology and NIV parameters:
  • Associations between changes in PROs (MRC, CAT, symptom diary, and EQ-5D-5L questionnaires) with routine clinical care interventions, COPD exacerbation and other clinical events.

  • Associations between changes in wearable monitoring parameters (activity, sleep, heart rate variability, energy expenditure, respiratory rate) with routine clinical care interventions, COPD exacerbation and other clinical events.

  • Associations between changes in NIV-monitored parameters (usage, leak, airway pressures, respiratory rate, tidal volume, minute ventilation, inspiratory/expiratory ratio and detected respiratory events) with routine clinical care treatment interventions, COPD exacerbation and other clinical events.

  • Associations between changes in clinical endpoints and relative importance plots of all remote management-acquired data (including EMG, oscillometry and home pollution monitoring exploratory endpoints in subgroup these measured on) to determine contribution of these to outcome prediction, and therefore value of these for future prospective study.


Patient-centred outcomes:
  • Health-related quality of life (EQ-5D-5L) at baseline and monthly during study.

  • Qualitative user research (planned subset of participants, convenience sample) with semistructured user experience interviews.

  • Impact of patient activation (where this is measured at baseline and/or follow-up during routine clinical care) on enrolment and use of digital service model.


Healthcare cost analyses:
  • Development and installation costs for digitalised service model for remote management of COPD.

  • Recurring costs (clinical staffing, digital platform hosting, digital platform scheduled update and maintenance) for digital service model for remote management of COPD.

  • Projected direct and indirect cost-savings (admission and unscheduled care reduction, travel, carer burden impact, clinical efficiency) of high-risk COPD with digitally enabled remote management, compared with previous service model.

  • CAT, Chronic obstructive pulmonary disease assessment tool; COPD, chronic obstructive pulmonary disease; EMG, Electromyography; MRC, Medical Research Council dyspnea scale; NIV, non-invasive ventilation; PROs, patient-reported outcomes; RECEIVER, Remote-Management of COPD: Evaluating the Implementation of Digital Innovation to Enable Routine Care.