EAPOC-COPD System for COPD (EAPOC-COPD Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Women's College Hospital

No Placebo Group

Trial Summary

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 burden Process 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 analytics Population: 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.

Exclusion Criteria

I do not want to use the EAPOC-COPD system.

Participant Groups

The study tests a digital tool called EAPOC-COPD against usual care in managing COPD. It's a stepped wedge cluster randomized controlled trial where each site transitions to the new system over time and serves as its own control before switching.

2Treatment groups

Experimental Treatment

Active Control

Group I: EAPOC-COPD systemExperimental Treatment1 Intervention

The EAPOC-COPD system consists of: 1) a smart phone / tablet app or PC-based questionnaire which collects information directly from patients upon prompting, up to 1 week before their clinical appointment; and 2) a point-of-care CDSS that wirelessly receives and processes questionnaire data in order to produce a symptom severity/exacerbation risk assessment, medication change recommendation, and COPD action plan, all of which is made available to providers through a prompt, upon opening the patient chart in the existing EMR. Once approved, the personalized COPD action plan is automatically populated within the patient app/portal, enabling anywhere/anytime access for patients. Patients are also provided with educational resources within their app/portal, designed to improve health literacy, inhaler technique, and adherence to their action plan.

Group II: Control armActive Control1 Intervention

Prior to activation of the EAPOC-COPD system, providers will provide usual care to their patients with COPD