The Electronic Asthma Action Plan System for Implementation in Primary Care

Asthma Clinical Trial

— eAAPS  

Official title:

The Electronic Asthma Action Plan System for Implementation in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01070095
• Other study ID #: 10-052
• Status: Completed
• Phase: N/A
• Start date: July 2012
• Est. completion date: August 2014

Study information

• Verified date: September 2019
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• Electronic 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.

Locations

Country	Name	City	State
Canada	Wise Elephant Family Health Team	Brampton	Ontario
Canada	McMaster Family Health Team	Hamilton	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	24 months
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.		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	24 months
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	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)	24 months
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	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)	13 months
Secondary	Ratio of Rescue to Controller Medication Prescriptions	Ratio of rescue to controller medication prescriptions made during baseline vs intervention periods	24 months
Secondary	Adherence Discussions	The number of patients in the intervention period in whom discussions about medication adherence took place	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	During the 12 month intervention period