- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01070095
The Electronic Asthma Action Plan System for Implementation in Primary Care (eAAPS)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Brampton, Ontario, Canada, L6X 1N3
- Wise Elephant Family Health Team
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Hamilton, Ontario, Canada, L8N 3Z6
- McMaster Family Health Team
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Toronto, Ontario, Canada, M5B 1W8
- St. Michael's Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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 and on an asthma medication [but not a Chronic Obstructive Pulmonary Disease (COPD) medication] within 1 year;
- patients >/= 16 years of age who understand English
Exclusion Criteria:
- Pregnant patients will be excluded given that conventional AAP recommendations may not be appropriate in this population.
- Any patient deemed to have cognitive limitations or a life expectancy of < 1 year
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Electronic Asthma Action Plan System
Electronic Asthma Action Plan System (eAAPS)
|
The electronic asthma action plan system consists of a tablet device in the physician waiting room which participants use to complete a simple questionnaire, a computerized clinical decision support system which then processes these data to produce a set of asthma care recommendations for the clinician, and finally, a printable asthma action plan that is given to patients, along with the URL for an asthma education website.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants to Whom an AAP (Asthma Action Plan) Was Delivered by the Clinician
Time Frame: 24 months
|
Number of eligible patients to whom an AAP was delivered by the physician during the intervention period (52 weeks) compared to the baseline period (52 weeks) Predictor model to include: clinic, appointment provider practitioner type, prior objective diagnosis of asthma, documented physician diagnosis of asthma, presenting complaint type, billing physician (most responsible physician/other), previous emergency department (ED) visits/hospitalizations for asthma, and current asthma control
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Impact of the eAAPS on Patient-relevant Outcomes Including Hospitalisations, Emergency Room Visits, Unscheduled & Total Visits to the Doctor, Days Off Work/School, Nocturnal/Daytime Asthma Symptoms, Daytime Rescue Bronchodilator Use & Quality of Life.
Time Frame: Every 2 weeks for 6 months
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Every 2 weeks for 6 months
|
|
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Asthma Control Assessment
Time Frame: 24 months
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The number of patients with asthma control determined at least once, according to symptom-based criteria (control determination required meeting one or more criteria for uncontrolled asthma or all criteria for controlled asthma). Predictor model to include: clinic, appointment provider practitioner type, prior objective diagnosis of asthma, documented physician diagnosis of asthma, presenting complaint type, billing physician (most responsible physician/other), previous emergency department (ED) visits/hospitalizations for asthma, and current asthma control |
24 months
|
|
Medication Escalations
Time Frame: 24 months
|
The number of patients with escalation of controller therapy Predictor model to include: clinic, appointment provider practitioner type, prior objective diagnosis of asthma, documented physician diagnosis of asthma, presenting complaint type, billing physician (most responsible physician/other), previous emergency department (ED) visits/hospitalizations for asthma, and current asthma control
|
24 months
|
|
Appropriate Medication Changes
Time Frame: 24 months
|
Number of eligible visits in which patients who had an appropriate medication change made (i.e.
escalation for poor control, and de-escalation for good control, when ascertainable)
|
24 months
|
|
On Treatment Analysis
Time Frame: During the 12 month intervention period
|
Number of eligible patients to whom an asthma action plan (AAP) was delivered, when decision support was available (52 weeks), counting only intervention period visits in which patients completed the questionnaire before the appointment and the notification prompted clinicians to open the computerized clinical decision support system (CDSS) to take action
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During the 12 month intervention period
|
|
Number of Practitioners Completing Feedback Questionnaires
Time Frame: 13 months
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Number of practitioners completing feedback questionnaires on the system (delivered in the 1 month after end of intervention period)
|
13 months
|
|
Ratio of Rescue to Controller Medication Prescriptions
Time Frame: 24 months
|
Ratio of rescue to controller medication prescriptions made during baseline vs intervention periods
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24 months
|
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Adherence Discussions
Time Frame: During the 12 month intervention period
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The number of patients in the intervention period in whom discussions about medication adherence took place
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During the 12 month intervention period
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System Uptake
Time Frame: During the 12 month intervention period
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Actual usage of the system: number of patients for whom clinicians accessed the CDSS when actions were required
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During the 12 month intervention period
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Samir Gupta, MDCM, Unity Health Toronto
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-052
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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