Clinical trial NCT06852339: Evaluating the EAPOC-COPD System
Official title: Bringing Evidence to the Point-of-Care in Chronic Obstructive Pulmonary Disease: the EAPOC-COPD System
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: COPD
Keywords: COPD
clinical decision support
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped wedge cluster randomized controlled trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in COPD pharmacotherapy at the provider level
timeFrame: 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)
Secondary outcomes:
measure: Provider changes in comprehensive symptom and exacerbation risk assessment
timeFrame: 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)
measure: Provider changes in COPD action plan delivery
timeFrame: 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)
measure: Provider changes in influenza vaccination rates
timeFrame: 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)
measure: Provider changes in smoking cessation advice provision
timeFrame: 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)
measure: Provider changes in referral to pulmonary rehabilitation in appropriate patients
timeFrame: 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)
Other outcomes:
measure: Process metrics: provider uptake of EAPOC-COPD
timeFrame: From start of intervention period to study end at 56 weeks
measure: Process metrics: patient uptake of EAPOC-COPD
timeFrame: From start of intervention period to study end at 56 weeks
measure: User satisfaction questionnaire - providers
timeFrame: From week 52 to week 56 of the trial
measure: User satisfaction questionnaire - patients
timeFrame: 2 weeks after first access to patient portal/app
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital, Unity Health Toronto
state: Ontario
Study officials:
References: