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

February 16, 2010
April 25, 2014
July 2012
August 2014   (final data collection date for primary outcome measure)
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
The primary outcome will be the percentage 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 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01070095 on ClinicalTrials.gov Archive Site
  • 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)
The impact of an eAAP system 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 ]
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
Not Provided
 
The Electronic Asthma Action Plan System for Implementation in Primary Care
The Electronic Asthma Action Plan System for Implementation in Primary Care

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Asthma
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.
Experimental: Electronic Asthma Action Plan System
Electronic Asthma Action Plan System
Intervention: Other: Electronic Asthma Action Plan System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
August 2014
August 2014   (final data collection date for primary outcome measure)

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.
Both
16 Years and older
No
Contact: Samir Gupta 416-864-6060 ext 2252 guptas@smh.ca
Contact: Sharon Straus 416-864-6060 ext 3068
Canada
 
NCT01070095
10-052
No
St. Michael's Hospital, Toronto
St. Michael's Hospital, Toronto
Canadian Institutes of Health Research (CIHR)
Not Provided
St. Michael's Hospital, Toronto
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP