Evaluating the EAPOC-COPD System

Not Applicable

Not yet recruiting

• Conditions: COPD

• Registration Number: NCT06852339
• Lead Sponsor: Women's College Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-20
• Study First Submitted QC: 2025-02-25
• Last Update Submitted: 2025-02-25
• Study First Posted: 2025-02-28
• Last Update Posted: 2025-02-28
• Study Start: 2025-07-01
• Primary Completion: 2026-07-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 131

Inclusion Criteria

• Providers working at clinical site currently using IT infrastructure that allows for integration of EAPOC-COPD
• Providers caring for patients with COPD

Exclusion Criteria

• Unwilling to use EAPOC-COPD system

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Changes in COPD pharmacotherapy at the provider level	As provider behaviour is what is being measured, the time frame will be from site/provider recruitment (week 1) until the end of the study period (week 56)	Defined by the proportion of patients whose COPD medications were escalated ("stepped-up" from short- to long-acting bronchodilator, single to dual, or dual to triple therapy), measured at the provider level

Secondary Outcome Measures

Name	Time	Method
Provider changes in comprehensive symptom and exacerbation risk assessment	As provider behaviour is what is being measured, the time frame will be from site/provider recruitment (week 1) until the end of the study period (week 56)	Will be measured by chart review, based on the presence of absence of COPD assessment test scoring
Provider changes in referral to pulmonary rehabilitation in appropriate patients	As provider behaviour is what is being measured, the time frame will be from site/provider recruitment (week 1) until the end of the study period (week 56)	Measured by chart review
Provider changes in COPD action plan delivery	As provider behaviour is what is being measured, the time frame will be from site/provider recruitment (week 1) until the end of the study period (week 56)	Will be measured by chart review
Provider changes in influenza vaccination rates	As provider behaviour is what is being measured, the time frame will be from site/provider recruitment (week 1) until the end of the study period (week 56)	Measured by chart review
Provider changes in smoking cessation advice provision	As provider behaviour is what is being measured, the time frame will be from site/provider recruitment (week 1) until the end of the study period (week 56)	Measured by chart review

Trial Locations

Locations (1)

St. Michael's Hospital, Unity Health Toronto; 🇨🇦 Toronto, Ontario, Canada