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

Phone	+44 (0)121 414 3765
Email	f.d.r.hobbs@bham.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Other
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/10/1994
Completion date	30/04/1997

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	368
Key inclusion criteria	Patients receiving warfarin therapy (n=368)
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/10/1994
Date of final enrolment	30/04/1997

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

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

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

Website	http://www.doh.gov.uk

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 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

Study outputs

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