Evaluating the EAPOC-COPD System

NCT06852339 | Not Yet Recruiting

• 1 other identifier: PSI Grant Number: 24-08
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the implementation and impact of the Evidence-at-the-Point-of-Care Chronic Obstructive Pulmonary Disease (EAPOC-COPD) system, a computerized clinical decision support system designed to improve the quality of COPD care delivered in community pharmacies. Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and healthcare utilization, and significant gaps persist in key evidence-based practices, including symptom and exacerbation risk assessment, appropriate pharmacotherapy, provision of COPD action plans, and referral for specialist care. The EAPOC-COPD system builds on a previously validated asthma platform and provides pharmacists with guideline-based decision support through a structured patient questionnaire and point-of-care recommendations, including treatment optimization and generation of personalized action plans. This study will be conducted across six community pharmacies implementing the EAPOC-COPD system as part of a quality improvement initiative. Using a quasi-experimental interrupted time series design, outcomes during a 12-month intervention period will be compared to a 12-month pre-intervention baseline period. The study will evaluate both implementation outcomes (including system uptake, usability, feasibility, and acceptability among pharmacy teams and patients) and effectiveness outcomes. Effectiveness outcomes include improvements in guideline-based COPD care processes, such as rates of symptom and exacerbation risk assessment, optimization of pharmacotherapy, provision of COPD action plans, and appropriate referral for specialist care. Results from this study will inform the scalability and broader implementation of pharmacy-based clinical decision support tools to enhance chronic disease management and support the expanding role of pharmacists in delivering evidence-based COPD care.

Conditions

COPD

Keywords

COPD; clinical decision support

Outcome Measures

Primary Outcomes (6)

• Implementation outcomes - System usage

  System usage (pharmacy team/patients) is a composite outcome that reflects the different usage metrics available in our system, including nature of visit (virtual vs in-person), specific content accessed, and time required for access/documentation

  During the 1 year intervention period

• Implementation outcome - usability

  Perceived system usability (pharmacy team members, will be collected by using the 10-item System Usability Scale - SUS

  During the 1 year intervention period

• Implementation outcome - system satisfaction

  satisfaction with/willingness to continue using the system (pharmacy team/patients), collected by questionnaire

  During the 1 year intervention period

• Implementation outcome - Prescription sign-back

  Proportion of prescriptions sent to doctors for sign-back that are sent back, will be collected from pharmacy chart system review

  During the 1 year intervention period

• Implementation outcome - perceived pharmacist cost-benefit

  Revenue for time spent, perceived value of customer loyalty realized, and compared to the baseline period, collected by questionnaire

  During the 1 year intervention period

• Implementation outcome - revenue metrics

  Composite outcome made up of proportion of patients for whom a pharmaceutical opinion and/or MedsCheck was successfully billed, total average revenue per eligible patient (pharmaceutical opinions, MedsChecks, markups, dispensing fees) and overall reimbursement for time spent

  During the 1 year intervention period

Secondary Outcomes (4)

• Effectiveness outcomes - COPD symptoms are exacerbation risk

  During the 1 year intervention period compared to the year prior

• Effectiveness outcome - COPD medications adjusted

  During the 1 year intervention period compared to the year prior

• Effectiveness outcome - action plans created

  During the 1 year intervention period compared to the year prior

• Effectiveness outcome - specialist referral

  During the 1 year intervention period compared to the year prior

Study Arms (1)

EAPOC-COPD system

EXPERIMENTAL

The EAPOC-COPD system consists of: 1) a smart phone / tablet app or PC-based questionnaire which collects information directly from patients upon prompting; 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 pharmacy providers electronically. Once approved (by pharmacists or through provider sign-back), 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.

Behavioral: EAPOC-COPD

Interventions

EAPOC-COPD BEHAVIORAL

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; 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 pharmacy providers electronically. 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 system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

The study will involve two groups of participants: pharmacy team members and adult patients with COPD who interact with the EAPOC-COPD system during pharmacy encounters. Pharmacy team participants will include pharmacists, registered pharmacy technicians, pharmacy assistants, and students working at one of the six participating community pharmacies. Individuals will be eligible if they are employed at one of the participating sites, have used the EAPOC-COPD system during the study period, are able to provide informed consent, and are able to complete an electronic questionnaire in English. Individuals will be excluded if they have not used the system during the study period or decline to participate. Patient participants will include adults aged 18 years or older who interact with the EAPOC-COPD system during routine pharmacy care. Eligible patients will be those identified by pharmacy staff as receiving COPD-related care and who complete the EAPOC-COPD patient questionnaire during their pharmacy encounter. Patients must have also indicated willingness to be contacted regarding research participation and be able to provide informed consent. Patients who are under 18 years of age, otherwise unable to provide informed consent, or who decline participation will be excluded.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Women's College Hospital: lead

Study Sites (1)

St. Michael's Hospital, Unity Health Toronto

Toronto, Ontario, M5B 1W8, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Andrew Kouri, MD, PhD

CONTACT

(416)-864-6060; andrew.kouri@unityhealth.to

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Blinding will not be possible for participating providers or patients, given the nature of the EAPOC-COPD intervention as a point-of-care clinical decision support system integrated into routine care workflows.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist and Staff physician

Model Details: Interrupted time series study

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 28, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: May 18, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)