Contact information
Type
Scientific
Contact name
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/CTIS number
IRAS 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(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
GP practice
Study 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
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
Overall study end date
30/04/1997
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients receiving warfarin therapy (n=368)
Participant type(s)
Patient
Age group
Not Specified
Sex
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
England, United Kingdom
Study 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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2000 | Yes | No |