The Electronic Asthma Management System

Not Applicable

Not yet recruiting

• Conditions: Asthma

• Registration Number: NCT03193242
• Lead Sponsor: Unity Health Toronto

Brief Summary

This study is an extension of a pilot study in which investigators developed and tested a computerized tool to help physicians to determine if their patients' asthma is well controlled, advise them on medication changes required according to the current level of control, and automatically generate an electronic version of the AAP, all based on patient responses to a questionnaire completed by patients on a tablet computer. In this phase patients will have the ability to complete the questionnaire on their smartphones, through a pre-downloaded app and will have access to an electronic asthma self-management app.

Detailed Description

Asthma is a common and potentially fatal chronic disease. An asthma action plan (AAP) is a written plan produced by a physician for a patient with asthma, to provide education and guidelines for self-management of worsening asthma symptoms. Studies have shown that AAPs effectively improve asthma control, but physicians fail to provide AAPs due to lack of time and adequate skills. Physicians also often fail to determine if their patients have good asthma control, and to adjust medications in response to patients' control level.

In a pilot study investigators developed and tested a computerized tool to help physicians to determine if their patients' asthma is well controlled, advise them on medication changes required according to the current level of control, and automatically generate an electronic version of the AAP, all based on patient responses to a questionnaire completed by patients on a tablet computer. In the pilot, investigators found that the tablet computers add a level of complexity to clinic flow. In this study patients will have the ability to complete the questionnaire on their smartphones, through a pre-downloaded app. Patients will also have access to an electronic asthma self-management tool called Breathe through which they can view their AAP and other asthma educational information.

The investigators hope that this system will eliminate the barriers that physicians face in determining asthma control, adjusting medications, and delivering an AAP, and will increase the frequency with which physicians are able to achieve these goals in patients with asthma. The objectives of the study are to determine the impact of this system on asthma action plan delivery by primary care physicians, the frequency of checking control level, and the frequency and appropriateness of asthma medication changes (in accordance with control). The investigators will also attempt to determine the impact of the system on hospitalisations, emergency room (ER) visits, unscheduled visits to the doctor, total visits to the doctor, days off work or school, nocturnal asthma symptoms, daytime asthma symptoms, daytime rescue puffer use, and quality of life, and to measure physicians' perceptions of and satisfaction with the system.

Study Timeline

• Study First Submitted: 2017-05-09
• Study First Submitted QC: 2017-06-19
• Study First Posted: 2017-06-20
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-10
• Study Start: 2024-12-01
• Primary Completion: 2025-12-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Eligible physicians will include all primary care physicians at the 4 sites.
• Eligible patients will include:

patients with asthma, as determined by a validated electronic chart record search algorithm for asthma; patients >/= 16 years of age.

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Exclusion Criteria

• Patients who received an AAP within the last 6 months (from their primary care physician, a respirologist, or any other source).
• Pregnant patients will be excluded given that conventional AAP recommendations may not be appropriate in this population.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of Received AAP	12 Months	The study's primary outcome will be the proportion of patients currently on a controller medication who received an AAP in the intervention sites compared to the control sites, over 1 year (as determined through an electronic chart review).

Secondary Outcome Measures

Name	Time	Method
Tool learnability	First 6 months of intervention	Focus group/interview to collect qualitative data on tool usability
System Use	12 months	Quantitative assessment of system use
Healthcare utilization rate	12 months	Secondary outcomes collected through patient questionnaire will measure healthcare utilization.
Quality of life	12 months	Secondary outcomes collected through patient questionnaires will measure quality of life.
Documented Asthma Control	12 months	The proportion of eligible patients who had asthma control documented
Health Care Utilization	12 months	Health care utilization will also be validated through linkage with health administrative databases.
System usability	First 6 months of intervention	Specific questionnaire to collect data on tool usability.
Any Medication Change	12 months	The proportion of eligible patients who had a medication change made
Appropriate Medication Change	12 months	The proportion of eligible patients who had an appropriate medication change made (based on asthma control, where ascertainable)

Trial Locations

Locations (2)

Wise Elephant Family Health Team; 🇨🇦 Brampton, Ontario, Canada

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada