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Not yet recruiting NCT06852339

Evaluating the EAPOC-COPD System

No phase Interventional COPD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EAPOC-COPD.
Who it may be relevant to
Registry conditions: COPD. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Behavioral EAPOC-COPD
    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 perso

Primary outcome measures

  • Implementation outcomes - System usage [Time frame: During the 1 year intervention period]
  • Implementation outcome - usability [Time frame: During the 1 year intervention period]
  • Implementation outcome - system satisfaction [Time frame: During the 1 year intervention period]
  • Implementation outcome - Prescription sign-back [Time frame: During the 1 year intervention period]
  • Implementation outcome - perceived pharmacist cost-benefit [Time frame: During the 1 year intervention period]
  • Implementation outcome - revenue metrics [Time frame: During the 1 year intervention period]
Secondary outcome measures (4)
  • Effectiveness outcomes - COPD symptoms are exacerbation risk [Time frame: During the 1 year intervention period compared to the year prior]
  • Effectiveness outcome - COPD medications adjusted [Time frame: During the 1 year intervention period compared to the year prior]
  • Effectiveness outcome - action plans created [Time frame: During the 1 year intervention period compared to the year prior]
  • Effectiveness outcome - specialist referral [Time frame: During the 1 year intervention period compared to the year prior]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Health services research

Study locations

Canada · 1 center
  • St. Michael's Hospital, Unity Health Toronto — Toronto

Identifiers

NCT: NCT06852339 · PSI Grant Number: 24-08

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗