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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by St. Michael's Hospital, Toronto
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT01070095
First received: February 16, 2010
Last updated: April 25, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Asthma
Other: Electronic Asthma Action Plan System
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Electronic Asthma Action Plan System for Implementation in Primary Care

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • The primary outcome will be the proportion 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). [ Time Frame: Every 2 weeks for 24 months ] [ Designated as safety issue: No ]
    12 months pre-intervention vs 12 months post-intervention


Secondary Outcome Measures:
  • The impact of the eAAPS on patient-relevant outcomes including hospitalisations, ER 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 ] [ Designated as safety issue: No ]
  • Proportion of all eligible patients who had asthma control documented [ Time Frame: Every 2 weeks for 24 months ] [ Designated as safety issue: No ]
    12 months pre-intervention vs 12 months post-intervention

  • Proportion of eligible patients who had a medication change made [ Time Frame: Every 2 weeks for 24 months ] [ Designated as safety issue: No ]
    12 months pre-intervention vs 12 months post-intervention

  • Proportion of eligible patients who had an appropriate medication change made (based on overall asthma control, when ascertainable) [ Time Frame: Every 2 weeks for 24 months ] [ Designated as safety issue: No ]
    12 months pre-intervention vs 12 months post-intervention

  • Proportion of eligible patients to whom an AAP was delivered by the physician during the intervention period, when decision support was available (52 weeks), compared to the baseline period (52 weeks). [ Time Frame: Every 2 weeks for 24 months ] [ Designated as safety issue: No ]
    This is an "on treatment" analysis (12 months pre-intervention vs 12 months post-intervention)


Other Outcome Measures:
  • Practitioner perceived utility and adoption of the system, satisfaction with the system, and barriers and facilitators to use of the system [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Questionnaires delivered in the 1 month after study end


Estimated Enrollment: 500
Study Start Date: July 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Electronic Asthma Action Plan System
Electronic Asthma Action Plan System
Other: Electronic Asthma Action Plan System
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01070095

Contacts
Contact: Samir Gupta 416-864-6060 ext 2252 guptas@smh.ca
Contact: Sharon Straus 416-864-6060 ext 3068

Locations
Canada, Ontario
Wise Elephant Family Health Team Recruiting
Brampton, Ontario, Canada, L6X 1N3
Contact: Sanjeev Goel, MD    905-459-4385    Sanjeev.goel@hqic.ca   
McMaster Family Health Team Recruiting
Hamilton, Ontario, Canada, L8N 3Z6
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Susan Hall       halls@smh.ca   
Principal Investigator: Samir Gupta         
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Canadian Institutes of Health Research (CIHR)
  More Information

No publications provided

Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT01070095     History of Changes
Other Study ID Numbers: 10-052
Study First Received: February 16, 2010
Last Updated: April 25, 2014
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on September 15, 2014