Condition category
Circulatory System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
01/12/2009
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

Prof FDR Hobbs

ORCID ID

Contact details

The Department of Primary Care and General Practice
Medical School
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 3765
f.d.r.hobbs@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PSI03-08

Study information

Scientific title

Acronym

Study hypothesis

Objectives of this study were to test the efficacy, cost effectiveness and safety of using a nurse-led clinic in primary care, involving near patient testing (NPT) and computerised decision support software (CDSS) for therapeutic oral anticoagulation management. The null hypothesis tested was that anticoagulation care can be provided at least as well in primary care as compared to routine hospital management based on a variety of previously validated and novel clinical outcome measures.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Other

Patient information sheet

Condition

Thromboembolic disease

Intervention

A randomised controlled trial using 12 primary care practices in Birmingham, UK (9 intervention and 3 control). The study used 2 control populations; patients individually randomly allocated as controls in the intervention practices (intra-practice controls), and all patients in the 3 control practices (inter-practice controls), included to estimate any Hawthorne effect amongst the intervention controls. Patients from the 9 intervention practices were randomised to intervention (practice based anticoagulation clinic) or control (traditional attendance at hospital clinic).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The main outcome measure used was INR control determined by; number of tests performed within target INR range; point prevalence of patients achieving individual therapeutic INR targets; and individual proportion of time spent within therapeutic target range.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/1994

Overall trial end date

30/04/1997

Reason abandoned

Eligibility

Participant inclusion criteria

Patients receiving warfarin therapy (n=368)

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

368

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/10/1994

Recruitment end date

30/04/1997

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Department of Primary Care and General Practice
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Primary and Secondary Care Interface National Research and Development Programme (UK)

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

2000 results in http://www.ncbi.nlm.nih.gov/pubmed/10927732

Publication citations

  1. Results

    Fitzmaurice DA, Hobbs FD, Murray ET, Holder RL, Allan TF, Rose PE, Oral anticoagulation management in primary care with the use of computerized decision support and near-patient testing: a randomized, controlled trial., Arch. Intern. Med., 160, 15, 2343-2348.

Additional files

Editorial Notes