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Computer-Based Decision Support in Managing Asthma in Primary Care

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
computer-based decision support for asthma management
Sponsored by
McGill University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Primary Care, Computer-Based Decision Support, Outcome Evaluation

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Physicians are eligible for inclusion if they are general practitioners or family physicians in full-time (≥ 4 days/week), fee-for-service practice in Quebec Patients where the study physician has written or dispensed prescriptions for beta2-agonists, anti-leukotrienes, or inhaled corticosteroids, and has verified the diagnosis of asthma Exclusion Criteria: Younger than 5 years old Diagnosis of COPD

Sites / Locations

  • McGill University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

1

2

Arm Description

Physicians in this arm will be using the standard MOXXI electronic health record.

In addition to the standard MOXXI electronic health record, physicians in this arm will be using the computer-based decision support for asthma management

Outcomes

Primary Outcome Measures

poor asthma control

Secondary Outcome Measures

quality of care indicators (inhaled corticosteroid to beta2-agonist ratio)

Full Information

First Posted
September 13, 2005
Last Updated
April 7, 2014
Sponsor
McGill University
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT00170248
Brief Title
Computer-Based Decision Support in Managing Asthma in Primary Care
Official Title
Evaluating the Impact of Computer-Based Decision Support for the Management of Asthma in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

5. Study Description

Brief Summary
Asthma is a health problem that afflicts many Canadians. Better methods are needed to provide primary care physicians with ways of implementing current guidelines into regular practice for optimal disease management. This study will test the benefits of providing computer-based decision-support for asthma to primary care physicians, with links to home monitoring for their patients. To add value and to ensure regular use for the physician for all of his/her patients, these computerized decision-support tools will be linked to an electronic prescribing and drug management system. The investigators will evaluate the effectiveness of the computer-based decision-support system by determining whether asthma patients of physicians who receive computer-assisted management tools have better disease control after 33 months of implementation compared to asthma patients of physicians who have the electronic prescription and drug management system alone. To answer this question, the investigators will conduct a cluster randomized controlled trial in a population of approximately 100 physicians in 40 clinics in Quebec, and a total of approximately 4500 of their patients with asthma.
Detailed Description
Background: Asthma is a chronic condition that is responsible for substantial morbidity. Direct costs for physicians, hospital care and medications in Canada are conservatively estimated at $306 million per year for persons with asthma. Existing evidence suggests that considerable reductions in morbidity could be achieved by early prevention and timely treatment. Much of the costs of asthma care are related to poor disease control due to under-use of effective prophylactic therapies, inadequate monitoring of disease severity, and insufficient patient education. A recent Canadian survey found that only 64% of patients with poor asthma control had been prescribed an inhaled corticosteroid, and of these only 52% made use of the medication on a daily basis. Further, although asthma self-management has been shown to reduce the relative risk of hospitalization for asthma by 39%, only 21% of asthma patients are provided with an action plan to institute for disease exacerbation and only 22% of primary care physicians provide action plans for their asthma patients on a regular basis. Computerized decision-support systems have provided a new set of tools for enabling integrated evidence-based care, by providing physicians with patient-specific reminders and alerts for needed preventive care and management, and timely feedback from patients. However, there has been limited use of computer-enabled decision-support in primary care, and only one reported study in chronic disease management. A key barrier to success has been the challenge of providing primary care physicians with a computerized solution that will produce value-added benefits and can be integrated easily into their routine workflow. Our prior research has shown that an integrated electronic prescribing and drug management system can provide value-added benefits for physicians because it is linked to information on dispensed medications, and alerts for prescribing problems. Early uptake and utilization of this computerized drug management system by primary care physicians provides an opportunity to develop and evaluate the effectiveness of an integrated asthma management decision-support system to enhance the use of prophylactic therapies and timely monitoring of asthma severity in primary care. Objective: To determine if computerized decision-support and home-monitoring systems for asthma that is integrated into an electronic prescription and drug management system can: a) increase quality of disease management, b) improve treatment outcomes for patients with asthma. Research Plan: A cluster-randomized trial with 33 months of follow-up will be conducted in a population of approximately 100 primary care physicians in full-time private fee-for-service practice in approximately 40 clinics in Quebec, and an estimated 2,880 - 4500 participating asthma patients within their practices. Enrolled physicians will receive the MOXXI electronic prescription and drug management software, equipped with wireless modem to access the central databases and application server, and wireless printer. This system allows physicians to write and send prescriptions electronically, provides alerts for potential prescribing errors, a profile of current and past medications through automated links with the provincial drug insurance plan and community-based pharmacies, a medication compliance calculator based on dispensed prescriptions, and automated problem list creation based on treatment indication and verification of diagnostic codes on medical services claims files. Clinics will be randomized to receive a) computerized decision-support and home-monitoring for asthma integrated with the MOXXI system or b) the MOXXI system alone. The asthma management decision support system uses data from the patient problem and medication list to provide patient-specific management recommendations based on Canadian Consensus guidelines for asthma management. Web-enabled technology for asthma education nurses is used to collect home-monitoring information from patients between visits and feedback to primary care physicians in accordance with options selected by the physician for each patient. The primary outcome, measured in each 3 month period of follow-up will be poor asthma control, defined as an ER visit or hospitalization for asthma in each 3 month period of follow-up or the dispensing of > 250 doses of fast-acting beta2-agonists. Secondary outcomes will include one evidence-based quality of care indicator (inhaled corticosteroid to beta2-agonist ratio, prescription of an action plan). Primary and secondary outcomes will be measured using data from the medical chart, records of prescribed and dispensed drugs, and Ministry of Health beneficiary, medical services and hospitalization databases. Effectiveness of computer-based decision support will be assessed by multivariate hierarchical modeling to take into account multiple measurements for the same patient, clustered within physician and clinic, and to adjust for baseline differences in patient characteristics. Also, we will examine whether the effectiveness of the intervention was modified by asthma control status and physicians' use of the MOXXI application by stratified analyses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Primary Care, Computer-Based Decision Support, Outcome Evaluation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
4447 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
Physicians in this arm will be using the standard MOXXI electronic health record.
Arm Title
2
Arm Type
Experimental
Arm Description
In addition to the standard MOXXI electronic health record, physicians in this arm will be using the computer-based decision support for asthma management
Intervention Type
Device
Intervention Name(s)
computer-based decision support for asthma management
Intervention Description
The asthma management decision support system uses data from the patient problem and medication list to provide patient-specific management recommendations based on Canadian Consensus guidelines for asthma management. Web-enabled technology for asthma education nurses is used to collect home-monitoring information from patients between visits and feedback to primary care physicians in accordance with options selected by the physician for each patient.
Primary Outcome Measure Information:
Title
poor asthma control
Time Frame
2006-2009
Secondary Outcome Measure Information:
Title
quality of care indicators (inhaled corticosteroid to beta2-agonist ratio)
Time Frame
2006-2009

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Physicians are eligible for inclusion if they are general practitioners or family physicians in full-time (≥ 4 days/week), fee-for-service practice in Quebec Patients where the study physician has written or dispensed prescriptions for beta2-agonists, anti-leukotrienes, or inhaled corticosteroids, and has verified the diagnosis of asthma Exclusion Criteria: Younger than 5 years old Diagnosis of COPD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robyn Tamblyn, PhD
Organizational Affiliation
McGill University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A3
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25670755
Citation
Tamblyn R, Ernst P, Winslade N, Huang A, Grad R, Platt RW, Ahmed S, Moraga T, Eguale T. Evaluating the impact of an integrated computer-based decision support with person-centered analytics for the management of asthma in primary care: a randomized controlled trial. J Am Med Inform Assoc. 2015 Jul;22(4):773-83. doi: 10.1093/jamia/ocu009. Epub 2015 Feb 10.
Results Reference
derived
Links:
URL
http://www.moxxi.mcgill.ca/
Description
global study website

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Computer-Based Decision Support in Managing Asthma in Primary Care

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