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.
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.
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 group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Physicians in this arm will be using the standard MOXXI electronic health record. |
| 2 | Experimental | In 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.
poor asthma control
Measured: 2006-2009
Secondary outcomes (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.
- First posted15 Sep 2005 (estimated)
- Study startOct 2006
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Robyn Tamblyn, McGill University
- Investigators
- Robyn Tamblyn, PhD, Principal investigator, McGill University
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Computer-Based Decision Support for the Management of Asthma in Primary Care
- ClinicalTrials.gov ID
- NCT00170248
- Acronym / sponsor ID
- ISRCTN58726678
- Conditions
- Asthma
- Keywords
- Asthma, Primary Care, Computer-Based Decision Support, Outcome Evaluation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,447 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Oct 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Physicians in this arm will be using the standard MOXXI electronic health record. |
| 2 | Experimental | Device: computer-based decision support for asthma managementIn addition to the standard MOXXI electronic health record, physicians in this arm will be using the computer-based decision support for asthma management |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Younger than 5 years old
- Diagnosis of COPD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| computer-based decision support for asthma managementThe 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. | Device | 2 |
Primary outcome
poor asthma control
Time frame: 2006-2009
1 secondary outcome
quality of care indicators (inhaled corticosteroid to beta2-agonist ratio)
Time frame: 2006-2009
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2014.
- Derived from this study: PubMed 25670755Tamblyn 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.
- global study websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robyn Tamblyn, PhD principal investigator
McGill University
1 site in 1 country: see every site and its status.
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.