Assessment of anticoagulant control in primary care using near patient testing and computerised decision support.

ISRCTN ISRCTN92166461
DOI https://doi.org/10.1186/ISRCTN92166461
Secondary identifying numbers PSI03-08
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
01/12/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof FDR Hobbs
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeOther
Scientific title
Study objectivesObjectives 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedThromboembolic disease
InterventionA 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 typeOther
Primary outcome measureThe 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 measuresNot provided at time of registration
Overall study start date01/10/1994
Completion date30/04/1997

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants368
Key inclusion criteriaPatients receiving warfarin therapy (n=368)
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment01/10/1994
Date of final enrolment30/04/1997

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

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

Sponsor information

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/08/2000 Yes No
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