- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07038642
- Original Trial
The Electronic Asthma Management System in Pharmacies (eAMS-Pharm)
The Electronic Asthma Management System in Pharmacies (eAMS-Pharm)
The goal of this study is to assess the effect of an electronic asthma management system in pharmacies (eAMS-Pharm) on asthma control assessment, asthma medication adjustment, asthma action plan delivery, and prompting for specialist referral in severe asthma. The study assesses the differences on pharmacy processes (affecting both the pharmacy team and patients) and pharmacy-delivered care using an interrupted time-series analysis (six-months before vs. six-months after the introduction of eAMS-Pharm in study pharmacy sites).
The eAMS-Pharm uses patient data (asthma control, asthma flare-up risk, and current medications) to provide clinical decision support to pharmacists, empowering them to bridge existing gaps between guideline-recommended asthma care and patient care received.
Study Overview
Status
Intervention / Treatment
Detailed Description
Asthma is the third most common chronic disease in adults and is increasing in prevalence. Although effective therapies exist and well-controlled asthma is achievable in most patients, studies demonstrate that up to 90% of Canadians with asthma are poorly controlled. This poor control and associated health system burden are attributable to 4 major gaps in care: 1) failure to ascertain asthma control according to guideline criteria; 2) failure to escalate pharmacotherapy in response to suboptimal control; 3) failure to provide a written asthma action plan (AAP) (a personalized plan produced by a health care professional for a patient, providing education and guidance for self-management of flares); and 4) failure to refer patients with severe asthma to specialty care for biologic therapies (these were 4 of the 6 quality statements in Health Quality Ontario's Asthma Quality Standards).
The Electronic Asthma Management System (eAMS) is a validated tool that has the potential to address the 4 major gaps in care. The eAMS consists of a web-based portal-based e-questionnaire, which collects asthma parameters directly from patients. A point-of-care Computerized Decision Support System (CDSS) receives and processes questionnaire data to produce guideline-based decision support such as assessments of asthma control, relevant medication change recommendations, and a personalized asthma action plan (AAP). There are also web-based education resources in the patient portal. The eAMS was proven to improve asthma management in primary care across these care gaps and is used in 16 primary care clinics, with ~215 providers and ~7200 patients with asthma. Now, with the increasingly critical role that pharmacists are playing in Canada's healthcare ecosystem, the eAMS can also be used to empower pharmacists to help optimize chronic disease care.
Pharmacists' scope of practice is growing rapidly in Ontario and across Canada. At the same time, asthma control remains suboptimal for millions of Canadians. Furthermore, the eAMS has been extensively studied and validated as an optimal tool to improve asthma management in primary care. The use of the eAMS in pharmacies presents a unique opportunity to involve pharmacists in chronic disease care while also reducing the burden on primary care. To address limited primary care access and given rapid the expansion of pharmacists' role of in care delivery, the investigators adapted the platform to build the eAMS-Pharm - a chronic disease quality improvement tool for pharmacists. The results of this study will inform the broader implementation of the eAMS across pharmacies and similar knowledge translation tools in pharmacies in the future.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Ontario
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Ajax, Ontario, Canada, L1L 2J5
- Medical Place Pharmacy
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Niagara Falls, Ontario, Canada, L2J 2K5
- LiveWell Pharmacy
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Waterloo, Ontario, Canada, N2L 2R5
- Westmount Place Pharmacy
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
- Eligible patients would be those who have asthma and are seen at one of the three study pharmacies during the study period
- Eligible pharmacy team members would be staff (pharmacists/RPhTs/assistants/students) at any one of the three study pharmacies
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control - None
A retrospective, pharmacy chart review will assess pharmacy-delivered care in the six-month pre-intervention period.
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Active Comparator: Intervention - The Electronic Asthma Management System in Pharmacies (eAMS-Pharm)
Throughout the intervention period, the eAMS-Pharm will be provided to pharmacists/RPhTs/assistants/students (for use in eligible patients).
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A pharmacy clinical decision support system that generates individualized advice for asthma patients is provided to the pharmacist/RPht/assistant/student.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Medication adjustments
Time Frame: 12 months, broken into individual time series periods
|
Using pharmacist chart review, the investigators will assess the proportion and trend in patients receiving medication adjustments
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12 months, broken into individual time series periods
|
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Asthma control assessment
Time Frame: 12 months, broken into individual time series periods
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Using pharmacist chart review, the investigators will assess the proportion and trend of patients receiving asthma control assessment by guideline criteria
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12 months, broken into individual time series periods
|
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Asthma action plan creation
Time Frame: 12 months, broken into individual time series periods
|
Using pharmacist chart review, the investigators will assess the proportion and trend of asthma action plans being created for patients
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12 months, broken into individual time series periods
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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System usage: virtual and in-person visit frequency
Time Frame: 6 months
|
Using pharmacist chart review, investigators will assess the number of times the system was used in virtual (i.e., telemedicine) visits and in in-person visits
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6 months
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System usage: content access frequency
Time Frame: 6 months
|
Using system analytics, investigators will assess the type of content accessed (clinical tools, clinical decisions, educational materials) by patients and pharmacy teams
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6 months
|
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System usage: patient engagement frequency, by method
Time Frame: 6 months
|
Using system analytics, investigators will assess the number of patients who engaged with the system by the programmatic (mass invite) method, or as a walk-in patient following programmatic invitations
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6 months
|
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System usage: time required for access and documentation
Time Frame: 6 months
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Using system analytics, investigators will assess how long it takes pharmacy teams to access and complete clinical decision making within the system.
Last screen timestamp minus first screen timestamp will be used to measure time
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6 months
|
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Quantitative patient Likert-Scale questionnaire
Time Frame: 6 months
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Exclusively throughout the intervention, electronic questionnaires developed by the investigators will be sent to consenting patients to assess quantitative patient feedback on system functionality and care quality received, as 5-point Likert scales.
Multiple choice and yes/no questions will also bee used to determine demographics and relevant asthma diagnosis information
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6 months
|
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Qualitative patient free-text feedback questionnaire
Time Frame: 6 months
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Exclusively throughout the intervention, electronic questionnaires developed by the investigators will be sent to consenting patients to assess qualitative patient feedback on benefits and drawbacks of the system, as measured through two free-text questions
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6 months
|
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Pharmacy team feedback: 10-item System Usability Scale - SUS
Time Frame: 6 months
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Exclusively throughout the intervention, electronic questionnaires developed by the investigators will be sent to consenting pharmacy team members to assess feedback on system usability, as measured by The System Usability Scale (SUS), a 10-item 5-point Likert scale
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6 months
|
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Quantitative pharmacy Likert-Scale questionnaire
Time Frame: 6 months
|
Exclusively throughout the intervention, electronic questionnaires developed by the investigators will be sent to consenting pharmacy team members to assess quantitative pharmacy team feedback on technology interest, role of pharmacies in chronic disease care and asthma action plans, system functionality, and benefits and drawbacks of the system on pharmacy workflows, as measured with 5-point Likert scales
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6 months
|
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Qualitative pharmacy free-text feedback questionnaire
Time Frame: 6 months
|
Exclusively throughout the intervention, electronic questionnaires developed by the investigators will be sent to consenting pharmacy team members to assess qualitative pharmacy team feedback on system usage, as measured through 6 free text questions.
To supplement the outcome of revenue metrics, the pharmacy team feedback questionnaire will also ask pharmacy team members to estimate revenue for time spent
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6 months
|
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Prescription/action plan sign-back proportions
Time Frame: 12 months, broken into individual time series periods
|
Using pharmacist chart review, the investigators will assess the proportion of prescriptions/action plans which receive sign-back from prescribers in each analysis period
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12 months, broken into individual time series periods
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Revenue metrics: pharmaceutical opinion proportion
Time Frame: 12 months, broken into individual time series periods
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Using pharmacist chart review, the investigators will assess the proportion of eligible visits for which a pharmaceutical opinion was successfully billed
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12 months, broken into individual time series periods
|
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Revenue metrics: MedsCheck proportion
Time Frame: 12 months, broken into individual time series periods
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Using pharmacist chart review, the investigators will assess the proportion of eligible visits for which a MedsCheck was successfully billed
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12 months, broken into individual time series periods
|
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Revenue metrics: total dollar revenue per patient
Time Frame: 12 months, broken into individual time series periods
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Using pharmacist chart review, the investigators will assess the total average revenue per eligible patient by summing pharmaceutical opinion, MedsChecks, markups, and dispensing fees
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12 months, broken into individual time series periods
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Revenue metrics: dollar reimbursement for time spent in system
Time Frame: 6 months
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Using pharmacist chart review, the investigators will assess the overall reimbursement for time pharmacy team members spent in the system.
To measure, investigators will sum the total revenue per patient and divide by time spent in the system for each patient over visits.
An average will be calculated across all patients
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6 months
|
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Specialist referral prompt proportion
Time Frame: 12 months, broken into individual time series periods
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Using pharmacist chart review, the investigators will assess the proportion of severe asthma patients, as identified by medications currently prescribed and filled, and who are not already seeing a specialist, for whom a prompt for specialist referral was sent to the prescriber
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12 months, broken into individual time series periods
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 46441
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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