AsthmaeAAPSNCT01070095
The Electronic Asthma Action Plan System for Implementation in Primary Care
A study testing Electronic Asthma Action Plan System in people with Asthma, run by Unity Health Toronto at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Electronic Asthma Action Plan System
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 3 sitesCanada
- Study dates
- Jul 2012to Aug 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Wise Elephant Family Health Team
Brampton, Ontario, L6X 1N3
McMaster Family Health Team
Hamilton, Ontario, L8N 3Z6
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
About this study
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Electronic Asthma Action Plan System
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Asthma Action Plan SystemOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Electronic Asthma Action Plan System | Experimental | Electronic Asthma Action Plan System (eAAPS) Receives: Other: Electronic Asthma Action Plan System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Every 2 weeks for 6 months
Asthma Control Assessment
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
Measured: 24 months
Medication Escalations
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
Measured: 24 months
Appropriate Medication Changes
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)
Measured: 24 months
On Treatment Analysis
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
Measured: During the 12 month intervention period
Number of Practitioners Completing Feedback Questionnaires
Number of practitioners completing feedback questionnaires on the system (delivered in the 1 month after end of intervention period)
Measured: 13 months
Ratio of Rescue to Controller Medication Prescriptions
Ratio of rescue to controller medication prescriptions made during baseline vs intervention periods
Measured: 24 months
Adherence Discussions
The number of patients in the intervention period in whom discussions about medication adherence took place
Measured: During the 12 month intervention period
System Uptake
Actual usage of the system: number of patients for whom clinicians accessed the CDSS when actions were required
Measured: During the 12 month intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
- Study startJul 2012
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Samir Gupta, MDCM, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01070095
- Sponsor's protocol ID
- 10-052
- Acronym
- eAAPS
- Status last verified
- Sep 2019
- First submitted
- 16 Feb 2010
- Last updated
- 13 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 30696669
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Electronic Asthma Action Plan System for Implementation in Primary Care
- ClinicalTrials.gov ID
- NCT01070095
- Acronym / sponsor ID
- eAAPS / 10-052
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Jul 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 17 Feb 2010 (estimated)
- Results
- Posted 13 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electronic Asthma Action Plan System | Experimental | Other: Electronic Asthma Action Plan SystemElectronic Asthma Action Plan System (eAAPS) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Eligible physicians will include all primary care physicians at the 4 sites.
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic Asthma Action Plan SystemThe 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. | Other | Electronic Asthma Action Plan System |
Primary outcome
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
9 secondary outcomes
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
Asthma Control Assessment
Time frame: 24 months
Medication Escalations
Time frame: 24 months
Appropriate Medication Changes
Time frame: 24 months
On Treatment Analysis
Time frame: During the 12 month intervention period
Number of Practitioners Completing Feedback Questionnaires
Time frame: 13 months
Ratio of Rescue to Controller Medication Prescriptions
Time frame: 24 months
Adherence Discussions
Time frame: During the 12 month intervention period
System Uptake
Time frame: During the 12 month intervention period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30696669Price 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.
Related trials for Asthma
RecruitingObservational study
Asthma and Primary Arterial Hypertension: an Inflammatory Link?
Asthma Bronchial
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma
Asthma
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
Asthma
Active, not recruitingPhase 1
A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samir Gupta, MDCM principal investigator
Unity Health Toronto
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Asthma Action Plan System in people with Asthma, run by Unity Health Toronto at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants to Whom an AAP (Asthma Action Plan) Was Delivered by the Clinician (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01070095, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2019.