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

ISRCTN	ISRCTN27244875
DOI	https://doi.org/10.1186/ISRCTN27244875
Secondary identifying numbers	N/A

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

Mr Michael Paterson
Scientific

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

Study design	Cluster-randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study objectives	Laboratory-provided computerized decision support will improve anticoagulation control relative to usual care
Ethics approval(s)	Yes, August 2001
Health condition(s) or problem(s) studied	Various
Intervention	Anticoagulation control and monitoring with versus without laboratory-provided computerized decision support (CDS)
Intervention type	Other
Primary outcome measure	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 study start date	01/01/2002
Completion date	30/06/2003

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Physicians: 40; Patients: 380
Key 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
Key exclusion criteria	None
Date of first enrolment	01/01/2002
Date of final enrolment	30/06/2003

ICES

Toronto, Ontario
M4N 3M5
Canada

Ontario Program for Optimal Therapeutics (Canada)
Not defined

105 Main Street E, Level One
Hamilton, Ontario
L8N 1G6
Canada

"ROR"	https://ror.org/00tjpb250

Not defined

Ontario Program for Optimal Therapeutics (Canada)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan