The Electronic Asthma Action Plan System for Implementation in Primary Care (eAAPS)
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Electronic Asthma Action Plan System
Sponsored by

About this trial
This is an interventional supportive care trial for Asthma
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 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
Sites / Locations
- Wise Elephant Family Health Team
- McMaster Family Health Team
- St. Michael's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Electronic Asthma Action Plan System
Arm Description
Electronic Asthma Action Plan System (eAAPS)
Outcomes
Primary Outcome Measures
Number of Participants to Whom an AAP (Asthma Action Plan) Was Delivered by the Clinician
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
Secondary Outcome Measures
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.
Asthma Control Assessment
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
Medication Escalations
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
Appropriate Medication Changes
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)
On Treatment Analysis
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
Number of Practitioners Completing Feedback Questionnaires
Number of practitioners completing feedback questionnaires on the system (delivered in the 1 month after end of intervention period)
Ratio of Rescue to Controller Medication Prescriptions
Ratio of rescue to controller medication prescriptions made during baseline vs intervention periods
Adherence Discussions
The number of patients in the intervention period in whom discussions about medication adherence took place
System Uptake
Actual usage of the system: number of patients for whom clinicians accessed the CDSS when actions were required
Full Information
NCT ID
NCT01070095
First Posted
February 16, 2010
Last Updated
September 10, 2019
Sponsor
Unity Health Toronto
Collaborators
Canadian Institutes of Health Research (CIHR)
1. Study Identification
Unique Protocol Identification Number
NCT01070095
Brief Title
The Electronic Asthma Action Plan System for Implementation in Primary Care
Acronym
eAAPS
Official Title
The Electronic Asthma Action Plan System for Implementation in Primary Care
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto
Collaborators
Canadian Institutes of Health Research (CIHR)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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. The investigators propose to develop and test a computerized tool that will 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. 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). We 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.
Detailed Description
This is a 2-year prospective interrupted time series (ITS) study of usual asthma care (baseline period) (year 1) compared to care with the eAAPS in place (intervention period) (year 2). The setting is two academic family health teams (primary health care teams including family physicians, nurses, and allied health members) in Hamilton, Ontario and one community-based family health team in Brampton, Ontario.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Electronic Asthma Action Plan System
Arm Type
Experimental
Arm Description
Electronic Asthma Action Plan System (eAAPS)
Intervention Type
Other
Intervention Name(s)
Electronic Asthma Action Plan System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants to Whom an AAP (Asthma Action Plan) Was Delivered by the Clinician
Description
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
Time Frame
24 months
Secondary Outcome Measure Information:
Title
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
Title
Asthma Control Assessment
Description
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
Time Frame
24 months
Title
Medication Escalations
Description
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
Time Frame
24 months
Title
Appropriate Medication Changes
Description
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)
Time Frame
24 months
Title
On Treatment Analysis
Description
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
Time Frame
During the 12 month intervention period
Title
Number of Practitioners Completing Feedback Questionnaires
Description
Number of practitioners completing feedback questionnaires on the system (delivered in the 1 month after end of intervention period)
Time Frame
13 months
Title
Ratio of Rescue to Controller Medication Prescriptions
Description
Ratio of rescue to controller medication prescriptions made during baseline vs intervention periods
Time Frame
24 months
Title
Adherence Discussions
Description
The number of patients in the intervention period in whom discussions about medication adherence took place
Time Frame
During the 12 month intervention period
Title
System Uptake
Description
Actual usage of the system: number of patients for whom clinicians accessed the CDSS when actions were required
Time Frame
During the 12 month intervention period
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samir Gupta, MDCM
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wise Elephant Family Health Team
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6X 1N3
Country
Canada
Facility Name
McMaster Family Health Team
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z6
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
30696669
Citation
Price C, Agarwal G, Chan D, Goel S, Kaplan AG, Boulet LP, Mamdani MM, Straus SE, Lebovic G, Gupta S. Large care gaps in primary care management of asthma: a longitudinal practice audit. BMJ Open. 2019 Jan 29;9(1):e022506. doi: 10.1136/bmjopen-2018-022506.
Results Reference
derived
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The Electronic Asthma Action Plan System for Implementation in Primary Care
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