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NCT Number: NCT06852339

Evaluating the EAPOC-COPD System

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Michael's Hospital, Unity Health Toronto

Toronto, Ontario, M5B 1W8, Canada

Location contact

Andrew Kouri, MD, PhD

CONTACT

[email protected]

(416)-864-6060 ext. 2045

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Implementation outcomes - System usage

    Time frame: During the 1 year intervention period

    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

  2. Implementation outcome - usability

    Time frame: During the 1 year intervention period

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

  3. Implementation outcome - system satisfaction

    Time frame: During the 1 year intervention period

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

  4. Implementation outcome - Prescription sign-back

    Time frame: During the 1 year intervention period

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

  5. Implementation outcome - perceived pharmacist cost-benefit

    Time frame: During the 1 year intervention period

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

  6. Implementation outcome - revenue metrics

    Time frame: During the 1 year intervention period

    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

Secondary outcomes

  1. Effectiveness outcomes - COPD symptoms are exacerbation risk

    Time frame: During the 1 year intervention period compared to the year prior

    the proportion of visits in the intervention compared to baseline period in which patients had COPD symptoms and exacerbation risk assessed, as determined by pharmacy chart review

  2. Effectiveness outcome - COPD medications adjusted

    Time frame: During the 1 year intervention period compared to the year prior

    the proportion of visits in the intervention compared to baseline period in which patients had COPD medications adjusted, as determined by pharmacy chart review

  3. Effectiveness outcome - action plans created

    Time frame: During the 1 year intervention period compared to the year prior

    the proportion of visits in the intervention compared to baseline period in which patients had an action plan created, based on pharmacy chart review

  4. Effectiveness outcome - specialist referral

    Time frame: During the 1 year intervention period compared to the year prior

    The proportion of patients who had a specialist referral made

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew Kouri, MD, PhD

CONTACT

[email protected]

(416)-864-6060 ext. 2045

Sponsors and collaborators

Lead sponsor

Women's College Hospital

Other

Registry information

Official study title

Bringing Evidence to the Point-of-Care in Chronic Obstructive Pulmonary Disease: The EAPOC-COPD System

Acronym: EAPOC-COPD

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 28, 2025
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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