Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Laboratory-provided computerized decision support will improve anticoagulation control relative to usual care
Ethics approval
Yes, August 2001
Study design
Cluster-randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Various
Intervention
Anticoagulation control and monitoring with versus without laboratory-provided computerized decision support (CDS)
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Acceptability of the CDS service, as assessed by the proportion of physicians who would continue to use it if offered
2. Estimated effectiveness, as assessed by percentage of time within target INR range
Secondary outcome measures
Hemorrhagic and thromboembolic events requiring hospital attendance
Overall trial start date
01/01/2002
Overall trial end date
30/06/2003
Reason abandoned
Eligibility
Participant inclusion criteria
Physicians:
1. Family or general practitioner
2. Full-time office practice
3. Practice address within study laboratory catchment area
4. At least 3 eligible patients willing to participate
Patients:
1. On long-term warfarin therapy
2. Using the study laboratory for international normalized ratio (INR) tests and expecting to continue to do so for at least 12 months
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Physicians: 40; Patients: 380
Participant exclusion criteria
None
Recruitment start date
01/01/2002
Recruitment end date
30/06/2003
Locations
Countries of recruitment
Canada
Trial participating centre
ICES
Toronto, Ontario
M4N 3M5
Canada
Funders
Funder type
Not defined
Funder name
Ontario Program for Optimal Therapeutics (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary