Computer-Based Decision Support in Managing Asthma in Primary Care
|First Received Date ICMJE||September 13, 2005|
|Last Updated Date||January 28, 2014|
|Start Date ICMJE||October 2006|
|Primary Completion Date||June 2009 (final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||poor asthma control [ Time Frame: 2006-2009 ] [ Designated as safety issue: No ]|
|Original Primary Outcome Measures ICMJE
||poor asthma control|
|Change History||Complete list of historical versions of study NCT00170248 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||quality of care indicators (inhaled corticosteroid to beta2-agonist ratio) [ Time Frame: 2006-2009 ] [ Designated as safety issue: No ]|
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Computer-Based Decision Support in Managing Asthma in Primary Care|
|Official Title ICMJE||Evaluating the Impact of Computer-Based Decision Support for the Management of Asthma in Primary Care|
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.
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 6 month period of follow-up will be poor asthma control, defined as an ER visit or hospitalization for asthma in each 6 month period of follow-up or the dispensing of > 500 doses of short-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.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Intervention ICMJE||Device: computer-based decision support for asthma management
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.
|Study Arm (s)||
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||June 2009|
|Primary Completion Date||June 2009 (final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages||5 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Canada|
|NCT Number ICMJE||NCT00170248|
|Other Study ID Numbers ICMJE||ISRCTN58726678, 21448|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Robyn Tamblyn, McGill University|
|Study Sponsor ICMJE||McGill University|
|Collaborators ICMJE||Canadian Institutes of Health Research (CIHR)|
|Information Provided By||McGill University|
|Verification Date||January 2014|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP