Randomised comparison of anticoagulation control and monitoring with versus without laboratory-provided computerized decision support

ISRCTN ISRCTN27244875
DOI https://doi.org/10.1186/ISRCTN27244875
Protocol serial number N/A
Sponsor Ontario Program for Optimal Therapeutics (Canada)
Funder Ontario Program for Optimal Therapeutics (Canada)
Submission date
08/11/2005
Registration date
25/11/2005
Last edited
14/09/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Michael Paterson
Scientific

ICES
G106-2075 Bayview Ave.
Toronto, Ontario
M4N 3M5
Canada

Study information

Primary study designInterventional
Study designCluster-randomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study objectivesLaboratory-provided computerized decision support will improve anticoagulation control relative to usual care
Ethics approval(s)Yes, August 2001
Health condition(s) or problem(s) studiedVarious
InterventionAnticoagulation control and monitoring with versus without laboratory-provided computerized decision support (CDS)
Intervention typeOther
Primary outcome measure(s)

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

Key secondary outcome measure(s)

Hemorrhagic and thromboembolic events requiring hospital attendance

Completion date30/06/2003

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Target sample size at registration380
Key inclusion criteriaPhysicians:
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
Key exclusion criteriaNone
Date of first enrolment01/01/2002
Date of final enrolment30/06/2003

Locations

Countries of recruitment

  • Canada

Study participating centre

ICES
Toronto, Ontario
M4N 3M5
Canada

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan