Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
131 participants
INTERVENTIONAL
2025-07-01
2026-09-01
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SEQUENTIAL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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EAPOC-COPD system
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.
EAPOC-COPD
The EAPOC-COPD system consists of: 1) a smart phone / tablet app or Personal Computer-based questionnaire which collects information directly from patients upon prompting, up to 1 week before their clinical appointment; and 2) a point-of-care clinical decision support system 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
Control arm
Prior to activation of the EAPOC-COPD system, providers will provide usual care to their patients with COPD
Usual Care
Usual care
Interventions
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EAPOC-COPD
The EAPOC-COPD system consists of: 1) a smart phone / tablet app or Personal Computer-based questionnaire which collects information directly from patients upon prompting, up to 1 week before their clinical appointment; and 2) a point-of-care clinical decision support system 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
Usual Care
Usual care
Eligibility Criteria
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Inclusion Criteria
* Providers caring for patients with COPD
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Women's College Hospital
OTHER
Responsible Party
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Andrew Kouri
Scientist and Staff physician
Locations
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St. Michael's Hospital, Unity Health Toronto
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Andrew Kouri, MD, PhD
Role: primary
Other Identifiers
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PSI Grant Number: 24-08
Identifier Type: -
Identifier Source: org_study_id