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The Electronic Asthma Management System (eAMS)

Primary Purpose

Asthma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Electronic Asthma Management System: eAMS
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Asthma focused on measuring Asthma, Asthma Action Plan

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Wise Elephant Family Health Team
  • St. Michael's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
May 9, 2017
Last Updated
May 9, 2023
Sponsor
Unity Health Toronto
Collaborators
Ontario Lung Association
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1. Study Identification

Unique Protocol Identification Number
NCT03193242
Brief Title
The Electronic Asthma Management System
Acronym
eAMS
Official Title
eAMS: The Electronic Asthma Management System
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2024 (Anticipated)
Primary Completion Date
December 1, 2025 (Anticipated)
Study Completion Date
June 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto
Collaborators
Ontario Lung Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Asthma Action Plan

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Electronic Asthma Management System: eAMS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of Received AAP
Description
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).
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Documented Asthma Control
Description
The proportion of eligible patients who had asthma control documented
Time Frame
12 months
Title
Any Medication Change
Description
The proportion of eligible patients who had a medication change made
Time Frame
12 months
Title
Appropriate Medication Change
Description
The proportion of eligible patients who had an appropriate medication change made (based on asthma control, where ascertainable)
Time Frame
12 months
Title
Healthcare utilization rate
Description
Secondary outcomes collected through patient questionnaire will measure healthcare utilization.
Time Frame
12 months
Title
Quality of life
Description
Secondary outcomes collected through patient questionnaires will measure quality of life.
Time Frame
12 months
Title
Health Care Utilization
Description
Health care utilization will also be validated through linkage with health administrative databases.
Time Frame
12 months
Title
System Use
Description
Quantitative assessment of system use
Time Frame
12 months
Title
System usability
Description
Specific questionnaire to collect data on tool usability.
Time Frame
First 6 months of intervention
Title
Tool learnability
Description
Focus group/interview to collect qualitative data on tool usability
Time Frame
First 6 months of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Wise Elephant Family Health Team
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6X 1N3
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada

12. IPD Sharing Statement

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The Electronic Asthma Management System

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