Clinical trial NCT01070095: The Electronic Asthma Action Plan System for Implementation in Primary Care
Official title: The Electronic Asthma Action Plan System for Implementation in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2010-02-17
Enrollment: 19
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Number of Participants to Whom an AAP (Asthma Action Plan) Was Delivered by the Clinician
timeFrame: 24 months
Secondary outcomes:
measure: 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.
timeFrame: Every 2 weeks for 6 months
measure: Asthma Control Assessment
timeFrame: 24 months
measure: Medication Escalations
timeFrame: 24 months
measure: Appropriate Medication Changes
timeFrame: 24 months
measure: On Treatment Analysis
timeFrame: During the 12 month intervention period
measure: Number of Practitioners Completing Feedback Questionnaires
timeFrame: 13 months
measure: Ratio of Rescue to Controller Medication Prescriptions
timeFrame: 24 months
measure: Adherence Discussions
timeFrame: During the 12 month intervention period
measure: System Uptake
timeFrame: During the 12 month intervention period
Other outcomes:
Locations:
city: Brampton
country: Canada
facility: Wise Elephant Family Health Team
state: Ontario
city: Hamilton
country: Canada
facility: McMaster Family Health Team
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Samir Gupta, MDCM
role: PRINCIPAL_INVESTIGATOR
References:
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.