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The Electronic Asthma Management System (eAMS)

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ClinicalTrials.gov Identifier: NCT03193242
Recruitment Status : Not yet recruiting
First Posted : June 20, 2017
Last Update Posted : April 4, 2019
Sponsor:
Collaborator:
Ontario Lung Association
Information provided by (Responsible Party):
St. Michael's Hospital, 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.

Condition or disease Intervention/treatment Phase
Asthma Other: Electronic Asthma Management System: eAMS Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: eAMS: The Electronic Asthma Management System
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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).




Primary Outcome Measures :
  1. Proportion of Received AAP [ Time Frame: 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 :
  1. Documented Asthma Control [ Time Frame: 12 months ]
    The proportion of eligible patients who had asthma control documented

  2. Any Medication Change [ Time Frame: 12 months ]
    The proportion of eligible patients who had a medication change made

  3. Appropriate Medication Change [ Time Frame: 12 months ]
    The proportion of eligible patients who had an appropriate medication change made (based on asthma control, where ascertainable)

  4. Healthcare utilization rate [ Time Frame: 12 months ]
    Secondary outcomes collected through patient questionnaire will measure healthcare utilization.

  5. Quality of life [ Time Frame: 12 months ]
    Secondary outcomes collected through patient questionnaires will measure quality of life.

  6. Health Care Utilization [ Time Frame: 12 months ]
    Health care utilization will also be validated through linkage with health administrative databases.

  7. System Use [ Time Frame: 12 months ]
    Quantitative assessment of system use

  8. System usability [ Time Frame: First 6 months of intervention ]
    Specific questionnaire to collect data on tool usability.

  9. Tool learnability [ Time Frame: First 6 months of intervention ]
    Focus group/interview to collect qualitative data on tool usability



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193242


Locations
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Canada, Ontario
Wise Elephant Family Health Team
Brampton, Ontario, Canada, L6X 1N3
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Ontario Lung Association

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Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT03193242     History of Changes
Other Study ID Numbers: 10-052A
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by St. Michael's Hospital, Toronto:
Asthma
Asthma Action Plan

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases