The Electronic Asthma Action Plan System for Implementation in Primary Care (eAAPS)

September 10, 2019 updated by: Unity Health Toronto
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Brampton, Ontario, Canada, L6X 1N3
        • Wise Elephant Family Health Team
      • Hamilton, Ontario, Canada, L8N 3Z6
        • McMaster Family Health Team
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.

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
Every 2 weeks for 6 months
Asthma Control Assessment
Time Frame: 24 months

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
During the 12 month intervention period
Number of Practitioners Completing Feedback Questionnaires
Time Frame: 13 months
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
24 months
Adherence Discussions
Time Frame: During the 12 month intervention period
The number of patients in the intervention period in whom discussions about medication adherence took place
During the 12 month intervention period
System Uptake
Time Frame: During the 12 month intervention period
Actual usage of the system: number of patients for whom clinicians accessed the CDSS when actions were required
During the 12 month intervention period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Samir Gupta, MDCM, Unity Health Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

February 16, 2010

First Submitted That Met QC Criteria

February 16, 2010

First Posted (Estimate)

February 17, 2010

Study Record Updates

Last Update Posted (Actual)

September 13, 2019

Last Update Submitted That Met QC Criteria

September 10, 2019

Last Verified

September 1, 2019

More Information

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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