The Electronic Asthma Management System (eAMS)

eAMS: The Electronic Asthma Management System

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Asthma
• Intervention / Treatment: Other: Electronic Asthma Management System: eAMS

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Brampton, Ontario, Canada, L6X 1N3
      • Wise Elephant Family Health Team
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michael's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Electronic Asthma Management System: eAMS Intervention eAMS consists of simple questionnaire completed either through an app on a patient's smartphone or tablet computer, a computerized clinical decision support system which then processes these data to produce a set of asthma care recommendations for the clinician, and a printable asthma action plan that is given to patients. eAMS will also provide access to a patient-oriented asthma management tool called Breathe.	Other: Electronic Asthma Management System: eAMS; Electronic Asthma Management System: eAMS Intervention eAMS consists of simple questionnaire completed either through an app on a patient's smartphone or tablet computer, a computerized clinical decision support system which then processes these data to produce a set of asthma care recommendations for the clinician, and a printable asthma action plan that is given to patients. eAMS will also provide access to a patient-oriented asthma management tool called Breathe.
No Intervention: Control; Electronic Asthma Management System: eAMS - Control At control sites, eligible clinicians will be offered access to the web-based clinician-oriented asthma action plan (AAP) educational module produced by the Lung Association, copies of the Canadian Asthma Guidelines, and standard fillable paper-based AAPs (the eAMS will be offered after study end).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Received AAP	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).	12 Months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Unity Health Toronto
• Collaborators: Ontario Lung Association

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2024
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): June 1, 2026

Study Registration Dates

• First Submitted: May 9, 2017
• First Submitted That Met QC Criteria: June 19, 2017
• First Posted (Actual): June 20, 2017

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Asthma; Asthma Action Plan
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 10-052A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No