EAPOC-COPD System for COPD
(EAPOC-COPD Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It focuses on optimizing COPD treatment, which might involve changes to your medication, but it doesn't clearly state if you must stop any existing medications.
How is the EAPOC-COPD System treatment different from other COPD treatments?
The EAPOC-COPD System is unique because it likely involves a technology-based approach, possibly using wearable devices or mobile health systems, to monitor and manage COPD symptoms remotely, which can help in early detection and intervention of exacerbations, unlike traditional treatments that may not offer such real-time monitoring capabilities.12345
What is the purpose of this trial?
The EAPOC-COPD study is a stepped wedge cluster randomized controlled trial (SW-RCT) designed to evaluate the effectiveness of the Evidence at the Point-of-Care for COPD (EAPOC-COPD) system, a digital clinical decision support system (CDSS) integrated into primary care electronic medical records (EMRs). The system aims to improve COPD management by providing personalized pharmacotherapy recommendations, symptom and risk assessments, and self-management action plans, based on patient-reported data.Study Design:Six primary care sites in Ontario, Canada will transition from usual care to EAPOC-COPD-supported care in a staggered manner over 56 weeks. Each site will serve as its own control during the pre-intervention period.Primary Objective:To assess the impact of EAPOC-COPD on guideline-aligned pharmacotherapy optimization for COPD, measured by the proportion of patients with medication escalation.Secondary Objectives:Evaluate improvements in symptom/risk assessments (mMRC, CAT), COPD action plan delivery, influenza vaccination, smoking cessation support provision, pulmonary rehabilitation referrals, and COPD symptom burdenProcess Measures:Study investigators will also measure provider and patient uptake, satisfaction, and system feasibility will be assessed through EMR data audits, patient/provider surveys, and system usage analyticsPopulation:All prescribers at the six primary care sites (physicians and nurse practitioners) will be eligible. The study will involve patients with physician-diagnosed COPD, identified through EMR searches.Data Collection:Clinical outcomes will be obtained through chart reviews and data from the Canadian Primary Care Sentinel Surveillance Network (CPCSSN), where available. Patient-reported outcomes will be captured via questionnaires through the patient app/portal.Sample Size:An estimated 1860 COPD patients will be seen during the study. With an expected baseline medication escalation rate of 13%, the study is powered to detect an 8% absolute increase (assuming an Intra Class Correlation (ICC) =0.1).Analysis:A generalized linear mixed model (GLMM) will assess primary and secondary outcomes, accounting for time trends, clustering, and the stepped roll out.Significance:This trial will generate real-world evidence on the effectiveness of a point-of-care digital tool in closing COPD care gaps, with potential for large-scale primary care implementation.
Eligibility Criteria
This trial is for COPD patients being treated by providers at six primary care sites in Ontario, Canada. Providers must be using IT infrastructure compatible with the EAPOC-COPD system and caring for COPD patients. Those unwilling to use the EAPOC-COPD system are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pre-intervention
Sites provide usual care and serve as their own control
Intervention
Transition to EAPOC-COPD-supported care with digital clinical decision support system
Follow-up
Participants are monitored for safety and effectiveness after intervention
Treatment Details
Interventions
- EAPOC-COPD System
Find a Clinic Near You
Who Is Running the Clinical Trial?
Women's College Hospital
Lead Sponsor