Assessment of anticoagulant control in primary care using near patient testing and computerised decision support.
| ISRCTN | ISRCTN92166461 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92166461 |
| Protocol serial number | PSI03-08 |
| Sponsor | Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK) |
| Funder | NHS Primary and Secondary Care Interface National Research and Development Programme (UK) |
- 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
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 |
|---|---|
| f.d.r.hobbs@bham.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
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. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/04/1997 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
The Department of Primary Care and General Practice
Birmingham
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
