Trial Outcomes & Findings for The Electronic Asthma Action Plan System for Implementation in Primary Care (NCT NCT01070095)

NCT ID: NCT01070095

Last Updated: 2019-09-13

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

19 participants

Primary outcome timeframe

24 months

Results posted on

2019-09-13

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure
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
Electronic Asthma Action Plan System - Patients
Eligible patients from clinicians who consented to the study
Baseline Period
STARTED
19
830
Baseline Period
COMPLETED
18
830
Baseline Period
NOT COMPLETED
1
0
Intervention Period
STARTED
18
890
Intervention Period
COMPLETED
18
890
Intervention Period
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Electronic Asthma Action Plan System - Patients
n=1272 Participants
All eligible unique patients from clinicians who consented to the study
Age, Continuous
Baseline Period Age
45.9 years
STANDARD_DEVIATION 17.4 • n=830 Participants • 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.
Age, Continuous
Intervention Period Age
47.3 years
STANDARD_DEVIATION 17.2 • n=890 Participants • 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.
Sex: Female, Male
Baseline Period Sex · Female
602 Participants
n=830 Participants • 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.
Sex: Female, Male
Baseline Period Sex · Male
228 Participants
n=830 Participants • 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.
Sex: Female, Male
Intervention Period Sex · Female
632 Participants
n=890 Participants • 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.
Sex: Female, Male
Intervention Period Sex · Male
258 Participants
n=890 Participants • 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.

PRIMARY outcome

Timeframe: 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).

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

Outcome measures

Outcome measures
Measure
Baseline Period
n=412 Participants
12 months pre-intervention
Intervention Period
n=443 Participants
12 months post-intervention (eAAPS)
Number of Participants to Whom an AAP (Asthma Action Plan) Was Delivered by the Clinician
0 Participants
79 Participants

SECONDARY outcome

Timeframe: Every 2 weeks for 6 months

Population: Not measured due to inadequate patient outcome measurement recruitment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure
Baseline Period
n=830 Participants
12 months pre-intervention
Intervention Period
n=890 Participants
12 months post-intervention (eAAPS)
Asthma Control Assessment
118 Participants
523 Participants

SECONDARY outcome

Timeframe: 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)

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

Outcome measures

Outcome measures
Measure
Baseline Period
n=830 Participants
12 months pre-intervention
Intervention Period
n=890 Participants
12 months post-intervention (eAAPS)
Medication Escalations
106 participants
117 participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure
Baseline Period
n=3563 Visits
12 months pre-intervention
Intervention Period
n=3327 Visits
12 months post-intervention (eAAPS)
Appropriate Medication Changes
113 Visits
85 Visits

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure
Baseline Period
n=265 Participants
12 months pre-intervention
Intervention Period
12 months post-intervention (eAAPS)
On Treatment Analysis
81 Participants

SECONDARY outcome

Timeframe: 13 months

Population: Responding physicians. We have only presented data from the Intervention Period, as questionnaires were provided after the intervention only.

Number of practitioners completing feedback questionnaires on the system (delivered in the 1 month after end of intervention period)

Outcome measures

Outcome measures
Measure
Baseline Period
n=18 Participants
12 months pre-intervention
Intervention Period
12 months post-intervention (eAAPS)
Number of Practitioners Completing Feedback Questionnaires
12 Participants

SECONDARY outcome

Timeframe: 24 months

Ratio of rescue to controller medication prescriptions made during baseline vs intervention periods

Outcome measures

Outcome measures
Measure
Baseline Period
n=830 Participants
12 months pre-intervention
Intervention Period
n=890 Participants
12 months post-intervention (eAAPS)
Ratio of Rescue to Controller Medication Prescriptions
1.15 Ratio of SABAs to controllers prescribed
0.14 Ratio of SABAs to controllers prescribed

SECONDARY outcome

Timeframe: 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.

The number of patients in the intervention period in whom discussions about medication adherence took place

Outcome measures

Outcome measures
Measure
Baseline Period
n=890 Participants
12 months pre-intervention
Intervention Period
12 months post-intervention (eAAPS)
Adherence Discussions
219 Participants

SECONDARY outcome

Timeframe: 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.

Actual usage of the system: number of patients for whom clinicians accessed the CDSS when actions were required

Outcome measures

Outcome measures
Measure
Baseline Period
n=505 Participants
12 months pre-intervention
Intervention Period
12 months post-intervention (eAAPS)
System Uptake
174 Participants

Adverse Events

Baseline

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Samir Gupta

St. Michael's Hospital

Phone: (416) 864-6060

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place