- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06852339
Evaluating the EAPOC-COPD System (EAPOC-COPD)
Bringing Evidence to the Point-of-Care in Chronic Obstructive Pulmonary Disease: 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.
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Andrew Kouri, MD, PhD
- Phone Number: 2045 (416)-864-6060
- Email: andrew.kouri@unityhealth.to
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5B 1W8
- St. Michael's Hospital, Unity Health Toronto
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Contact:
- Andrew Kouri, MD, PhD
- Phone Number: 2045 (416)-864-6060
- Email: andrew.kouri@unityhealth.to
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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; 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.
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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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Implementation outcomes - System usage
Time Frame: During the 1 year intervention period
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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
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During the 1 year intervention period
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Implementation outcome - usability
Time Frame: During the 1 year intervention period
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Perceived system usability (pharmacy team members, will be collected by using the 10-item System Usability Scale - SUS
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During the 1 year intervention period
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Implementation outcome - system satisfaction
Time Frame: During the 1 year intervention period
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satisfaction with/willingness to continue using the system (pharmacy team/patients), collected by questionnaire
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During the 1 year intervention period
|
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Implementation outcome - Prescription sign-back
Time Frame: During the 1 year intervention period
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Proportion of prescriptions sent to doctors for sign-back that are sent back, will be collected from pharmacy chart system review
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During the 1 year intervention period
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Implementation outcome - perceived pharmacist cost-benefit
Time Frame: During the 1 year intervention period
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Revenue for time spent, perceived value of customer loyalty realized, and compared to the baseline period, collected by questionnaire
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During the 1 year intervention period
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Implementation outcome - revenue metrics
Time Frame: During the 1 year intervention period
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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
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During the 1 year intervention period
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effectiveness outcomes - COPD symptoms are exacerbation risk
Time Frame: During the 1 year intervention period compared to the year prior
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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
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During the 1 year intervention period compared to the year prior
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Effectiveness outcome - COPD medications adjusted
Time Frame: During the 1 year intervention period compared to the year prior
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the proportion of visits in the intervention compared to baseline period in which patients had COPD medications adjusted, as determined by pharmacy chart review
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During the 1 year intervention period compared to the year prior
|
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Effectiveness outcome - action plans created
Time Frame: During the 1 year intervention period compared to the year prior
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the proportion of visits in the intervention compared to baseline period in which patients had an action plan created, based on pharmacy chart review
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During the 1 year intervention period compared to the year prior
|
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Effectiveness outcome - specialist referral
Time Frame: During the 1 year intervention period compared to the year prior
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The proportion of patients who had a specialist referral made
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During the 1 year intervention period compared to the year prior
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Process metrics: provider uptake of EAPOC-COPD
Time Frame: From start of intervention period to study end at 56 weeks
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CDSS access proportion measured by system audit
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From start of intervention period to study end at 56 weeks
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Process metrics: patient uptake of EAPOC-COPD
Time Frame: From start of intervention period to study end at 56 weeks
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Patient questionnaire access proportion measured by system audit
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From start of intervention period to study end at 56 weeks
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User satisfaction questionnaire - providers
Time Frame: From week 52 to week 56 of the trial
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Questionnaires will collect demographic information and probe perceived utility of the system, readiness to adopt the system, satisfaction, and possible improvements, using open-ended and Likert scale-type questions (including the System Usability Scale - SUS)
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From week 52 to week 56 of the trial
|
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User satisfaction questionnaire - patients
Time Frame: 2 weeks after first access to patient portal/app
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Questionnaires will collect demographic information and probe perceived utility of the system, readiness to adopt the system, satisfaction, and possible improvements, using open-ended and Likert scale-type questions (including the System Usability Scale - SUS)
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2 weeks after first access to patient portal/app
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PSI Grant Number: 24-08
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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