Menu
Enrolling by invitation NCT07038642

The Electronic Asthma Management System in Pharmacies

No phase Interventional Pharmacy Asthma Management Asthma Computerized Decision Support System

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: Pharmacy Clinical Decision Support System for Asthma Management.
Who it may be relevant to
Registry conditions: Pharmacy, Asthma Management, Asthma, Computerized Decision Support System. Basic parameters: from 16 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

The Electronic Asthma Management System in Pharmacies (eAMS-Pharm)

Overview

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.

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.

Interventions

  • Behavioral Pharmacy Clinical Decision Support System for Asthma Management
    A pharmacy clinical decision support system that generates individualized advice for asthma patients is provided to the pharmacist/RPht/assistant/student.

Primary outcome measures

  • Medication adjustments [Time frame: 12 months, broken into individual time series periods]
  • Asthma control assessment [Time frame: 12 months, broken into individual time series periods]
  • Asthma action plan creation [Time frame: 12 months, broken into individual time series periods]
Secondary outcome measures (12)
  • System usage: virtual and in-person visit frequency [Time frame: 6 months]
  • System usage: content access frequency [Time frame: 6 months]
  • System usage: patient engagement frequency, by method [Time frame: 6 months]
  • System usage: time required for access and documentation [Time frame: 6 months]
  • Quantitative patient Likert-Scale questionnaire [Time frame: 6 months]
  • Qualitative patient free-text feedback questionnaire [Time frame: 6 months]
  • Pharmacy team feedback: 10-item System Usability Scale - SUS [Time frame: 6 months]
  • Quantitative pharmacy Likert-Scale questionnaire [Time frame: 6 months]
  • Qualitative pharmacy free-text feedback questionnaire [Time frame: 6 months]
  • Prescription/action plan sign-back proportions [Time frame: 12 months, broken into individual time series periods]
  • Revenue metrics: pharmaceutical opinion proportion [Time frame: 12 months, broken into individual time series periods]
  • Revenue metrics: MedsCheck proportion [Time frame: 12 months, broken into individual time series periods]

Eligibility criteria

  • 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

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

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Health services research

Study locations

Canada · 3 centers
  • Medical Place Pharmacy — Ajax
  • LiveWell Pharmacy — Niagara Falls
  • Westmount Place Pharmacy — Waterloo

Identifiers

NCT: NCT07038642 · 46441

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗