NCT01070095

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 17, 2010

Completed
2.4 years until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
5.1 years until next milestone

Results Posted

Study results publicly available

September 13, 2019

Completed
Last Updated

September 13, 2019

Status Verified

September 1, 2019

Enrollment Period

2.1 years

First QC Date

February 16, 2010

Results QC Date

September 6, 2018

Last Update Submit

September 10, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    24 months

Secondary Outcomes (9)

  • 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.

    Every 2 weeks for 6 months

  • Asthma Control Assessment

    24 months

  • Medication Escalations

    24 months

  • Appropriate Medication Changes

    24 months

  • On Treatment Analysis

    During the 12 month intervention period

  • +4 more secondary outcomes

Study Arms (1)

Electronic Asthma Action Plan System

EXPERIMENTAL

Electronic Asthma Action Plan System (eAAPS)

Other: Electronic Asthma Action Plan System

Interventions

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.

Electronic Asthma Action Plan System

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Wise Elephant Family Health Team

Brampton, Ontario, L6X 1N3, Canada

Location

McMaster Family Health Team

Hamilton, Ontario, L8N 3Z6, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Limitations and Caveats

An interrupted time series design is vulnerable to temporal factors that may have affected asthma care behaviour. We report on behavioural rather than health outcomes in this study.

Results Point of Contact

Title
Dr. Samir Gupta
Organization
St. Michael's Hospital

Study Officials

  • Samir Gupta, MDCM

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2010

First Posted

February 17, 2010

Study Start

July 1, 2012

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

September 13, 2019

Results First Posted

September 13, 2019

Record last verified: 2019-09

Locations