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AsthmaNCT00170248

Computer-Based Decision Support in Managing Asthma in Primary Care

A study testing computer-based decision support for asthma management in people with Asthma, run by McGill University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 5 years and older
Conditions the study is for
Asthma
What is being tested?
computer-based decision support for asthma management
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,447 participants
Where
1 siteCanada
Study dates
Oct 2006to Jun 2009
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Younger than 5 years old
  • Diagnosis of COPD

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • McGill University

    Montreal, Quebec, H3A 1A3

Other trials in Canada

About this study

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.

Read the 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.

Conditions
Asthma
Being tested
computer-based decision support for asthma management
Keywords
Asthma, Primary Care, Computer-Based Decision Support, Outcome Evaluation
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • computer-based decision support for asthma managementDevice

    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 groups in NCT00170248
Study groupRoleWhat they receive
1No interventionPhysicians in this arm will be using the standard MOXXI electronic health record.
2ExperimentalIn addition to the standard MOXXI electronic health record, physicians in this arm will be using the computer-based decision support for asthma management
Receives: Device: computer-based decision support for asthma management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. poor asthma control

    Measured: 2006-2009

Secondary outcomes (1)
  1. quality of care indicators (inhaled corticosteroid to beta2-agonist ratio)

    Measured: 2006-2009

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2005 (estimated)
  2. Study startOct 2006
  3. Primary completionJun 2009
  4. Study completionJun 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
4,447 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00170248
Sponsor's protocol ID
ISRCTN58726678
Other IDs
21448
Status last verified
Apr 2014
First submitted
13 Sep 2005
Last updated
8 Apr 2014
Results posted
No

Publications

  • 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.

    PubMed 25670755

Questions about this trial

What is this clinical trial studying?

A study testing computer-based decision support for asthma management in people with Asthma, run by McGill University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

poor asthma control (time frame: 2006-2009). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00170248, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2014.

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