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
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
-
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.