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临床试验/NCT06852339
NCT06852339尚未招募不适用

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

Women's College Hospital1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2026年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
25
试验地点
1
主要终点
Implementation outcomes - System usage

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
主要目的
Health Services Research
盲法
None (Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •Unwilling to use EAPOC-COPD system

研究组 & 干预措施

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.

干预措施: EAPOC-COPD (Behavioral)

结局指标

主要结局

Implementation outcomes - System usage

时间窗: 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

Implementation outcome - usability

时间窗: During the 1 year intervention period

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

Implementation outcome - system satisfaction

时间窗: During the 1 year intervention period

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

Implementation outcome - Prescription sign-back

时间窗: 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

Implementation outcome - perceived pharmacist cost-benefit

时间窗: 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

Implementation outcome - revenue metrics

时间窗: 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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrew Kouri

Scientist and Staff physician

Women's College Hospital

研究点 (1)

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