Asthma
Conditions
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.
Interventions
OTHERElectronic 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.
Sponsors
Canadian Institutes of Health Research (CIHR)
Unity Health Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants to Whom an AAP (Asthma Action Plan) Was Delivered by the Clinician | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Asthma Control Assessment | 24 months | 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 |
| Medication Escalations | 24 months | 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 |
| Appropriate Medication Changes | 24 months | 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) |
| On Treatment Analysis | During the 12 month intervention period | 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 |
| 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 | — |
| Ratio of Rescue to Controller Medication Prescriptions | 24 months | Ratio of rescue to controller medication prescriptions made during baseline vs intervention periods |
| Adherence Discussions | During the 12 month intervention period | The number of patients in the intervention period in whom discussions about medication adherence took place |
| System Uptake | During the 12 month intervention period | Actual usage of the system: number of patients for whom clinicians accessed the CDSS when actions were required |
| Number of Practitioners Completing Feedback Questionnaires | 13 months | Number of practitioners completing feedback questionnaires on the system (delivered in the 1 month after end of intervention period) |
Countries
Canada
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Electronic Asthma Action Plan System - Patients All eligible unique patients from clinicians who consented to the study | 1,272 |
| Total | 1,272 |
Baseline characteristics
| Characteristic | Electronic Asthma Action Plan System - Patients |
|---|---|
| Age, Continuous Baseline Period Age | 45.9 years STANDARD_DEVIATION 17.4 |
| Age, Continuous Intervention Period Age | 47.3 years STANDARD_DEVIATION 17.2 |
| Sex: Female, Male Baseline Period Sex Female | 602 Participants |
| Sex: Female, Male Baseline Period Sex Male | 228 Participants |
| Sex: Female, Male Intervention Period Sex Female | 632 Participants |
| Sex: Female, Male Intervention Period Sex Male | 258 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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
Time frame: 24 months
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Baseline Period | Number of Participants to Whom an AAP (Asthma Action Plan) Was Delivered by the Clinician | 0 Participants |
| Intervention Period | Number of Participants to Whom an AAP (Asthma Action Plan) Was Delivered by the Clinician | 79 Participants |
Secondary
Adherence Discussions
The number of patients in the intervention period in whom discussions about medication adherence took place
Time frame: During the 12 month intervention period
Population: We have only presented data from the Intervention Period, as this was not captured in the Baseline Period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Baseline Period | Adherence Discussions | 219 Participants |
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)
Time frame: 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Baseline Period | Appropriate Medication Changes | 113 Visits |
| Intervention Period | Appropriate Medication Changes | 85 Visits |
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
Time frame: 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Baseline Period | Asthma Control Assessment | 118 Participants |
| Intervention Period | Asthma Control Assessment | 523 Participants |
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
Time frame: 24 months
Population: 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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Baseline Period | Medication Escalations | 106 participants |
| Intervention Period | Medication Escalations | 117 participants |
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)
Time frame: 13 months
Population: Responding physicians. We have only presented data from the Intervention Period, as questionnaires were provided after the intervention only.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Baseline Period | Number of Practitioners Completing Feedback Questionnaires | 12 Participants |
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
Time frame: During the 12 month intervention period
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Baseline Period | On Treatment Analysis | 81 Participants |
Secondary
Ratio of Rescue to Controller Medication Prescriptions
Ratio of rescue to controller medication prescriptions made during baseline vs intervention periods
Time frame: 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Baseline Period | Ratio of Rescue to Controller Medication Prescriptions | 1.15 Ratio of SABAs to controllers prescribed |
| Intervention Period | Ratio of Rescue to Controller Medication Prescriptions | 0.14 Ratio of SABAs to controllers prescribed |
Secondary
System Uptake
Actual usage of the system: number of patients for whom clinicians accessed the CDSS when actions were required
Time frame: During the 12 month intervention period
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Baseline Period | System Uptake | 174 Participants |
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.
Time frame: Every 2 weeks for 6 months
Population: Not measured due to inadequate patient outcome measurement recruitment