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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electronic Asthma Action Plan System | Experimental | Electronic Asthma Action Plan System (eAAPS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electronic Asthma Action Plan System | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Eligible patients will include:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samir Gupta, MDCM | Unity Health Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wise Elephant Family Health Team | Brampton | Ontario | L6X 1N3 | Canada | ||
| McMaster Family Health Team |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30696669 | Derived | 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. |
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Only clinicians/practitioners were enrolled in the trial, but data were collected from patients of the clinicians so they are represented as a separate group. All asthma patients of enrolled clinicians were included in the analysis, but patients seen in the baseline/intervention periods were not necessarily the same and their number thus differs.
Recruitment was carried out across 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. Clinics used the OSCAR electronic medical record (EMR) system and were under a capitated funding model.
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| ID | Title | Description |
|---|---|---|
| FG000 | Electronic Asthma Action Plan System - Clinicians | All clinicians who consented to the study, who were invited to use the electronic asthma action plan system for their eligible patients |
| FG001 | Electronic Asthma Action Plan System - Patients | Eligible patients from clinicians who consented to the study |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Period |
| |||||||||||||
| Intervention Period |
|
The total number of unique patients across the two periods entered; data on clinician demographics were not captured exclusively for the 18 consenting clinicians
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| ID | Title | Description |
|---|---|---|
| BG000 | Electronic Asthma Action Plan System - Patients | All eligible unique patients from clinicians who consented to the study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 830 eligible patients were seen in the baseline period and 890 seen in the intervention period. There were 1272 unique patients seen over the study period, with 382 (30.0%) seen exclusively in the baseline period, 442 (34.8%) seen exclusively in the intervention period, and 448 (35.2%) seen in both periods. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Number of patients on an asthma controller medication [either inhaled corticosteroid (ICS), ICS/long-acting beta agonist (LABA), or leukotriene receptor antagonist (LTRA)] for at least 1 visit in the study period, who received an AAP, and had not received/reviewed an asthma action plan in the last 6 months (a subset of the intervention population). | Posted | Count of Participants | Participants | 24 months |
|
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All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed in physicians or patients with asthma at any time point during the study. This was a quality improvement study, with a tool to improve clinician practice. As such, participants were not considered at risk.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Baseline | 12 months pre-intervention | 0 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Samir Gupta | St. Michael's Hospital | (416) 864-6060 | 2252 | guptas@smh.ca |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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|
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 |
| 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 | 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) | 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 | 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) | 13 months |
| Ratio of Rescue to Controller Medication Prescriptions | Ratio of rescue to controller medication prescriptions made during baseline vs intervention periods | 24 months |
| Adherence Discussions | The number of patients in the intervention period in whom discussions about medication adherence took place | 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 | During the 12 month intervention period |
| Hamilton |
| Ontario |
| L8N 3Z6 |
| Canada |
| St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| NOT COMPLETED |
|
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | 830 eligible patients were seen in the baseline period and 890 seen in the intervention period. There were 1272 unique patients seen over the study period, with 382 (30.0%) seen exclusively in the baseline period, 442 (34.8%) seen exclusively in the intervention period, and 448 (35.2%) seen in both periods. | Count of Participants | Participants |
|
| Baseline Period |
12 months pre-intervention |
| OG001 | Intervention Period | 12 months post-intervention (eAAPS) |
|
|
| Secondary | 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. | Not measured due to inadequate patient outcome measurement recruitment | Posted | Every 2 weeks for 6 months |
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | 24 months |
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|
|
| Secondary | 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 | In the measuring therapy escalation, we eliminated visits in which patients had had a controller medication escalated within the last three months (the typical duration of a therapeutic trial) | Posted | Number | participants | 24 months |
|
|
|
| Secondary | 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) | Posted | Number | Visits | 24 months | Visits | Visits |
|
|
|
| Secondary | 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 | Number of eligible patients with AAP delivery. This counts only patients for whom a prompt was presented to the clinician, so is a subset of the intervention population. We have only presented data from the Intervention Period, as this outcome pertains to the uptake of the intervention, and is not applicable to the Baseline Period. | Posted | Count of Participants | Participants | During the 12 month intervention period |
|
|
|
| Secondary | 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) | Responding physicians. We have only presented data from the Intervention Period, as questionnaires were provided after the intervention only. | Posted | Count of Participants | Participants | 13 months |
|
|
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| Secondary | Ratio of Rescue to Controller Medication Prescriptions | Ratio of rescue to controller medication prescriptions made during baseline vs intervention periods | Posted | Number | Ratio of SABAs to controllers prescribed | 24 months |
|
|
|
| Secondary | Adherence Discussions | The number of patients in the intervention period in whom discussions about medication adherence took place | We have only presented data from the Intervention Period, as this was not captured in the Baseline Period. | Posted | Count of Participants | Participants | During the 12 month intervention period |
|
|
|
| Secondary | System Uptake | Actual usage of the system: number of patients for whom clinicians accessed the CDSS when actions were required | Number of patients for whom clinicians accessed the CDSS when actions were required based on the information entered in the questionnaire (a subset of the total intervention group). We have only presented data from the Intervention Period, as this outcome pertains to the uptake of the intervention, and is not applicable to the Baseline Period. | Posted | Count of Participants | Participants | During the 12 month intervention period |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Intervention | 12 months post-intervention (eAAPS) | 0 | 0 | 0 | 0 | 0 | 0 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |