Asthma Clinical Trial
Official title:
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 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.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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