Condition category
Circulatory System
Date applied
08/11/2005
Date assigned
25/11/2005
Last edited
14/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Michael Paterson

ORCID ID

Contact details

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

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

Sponsor information

Organisation

Ontario Program for Optimal Therapeutics (Canada)

Sponsor details

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

Sponsor type

Not defined

Website

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

Publication citations

Additional files

Editorial Notes