QAASM: an evaluation of three methods of external quality assurance for patient self-management of oral anticoagulation
| ISRCTN | ISRCTN35571063 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35571063 |
| Protocol serial number | G106/970 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | Medical Research Council (MRC) (UK) - Special Training Fellowship in HSR |
- Submission date
- 11/02/2003
- Registration date
- 11/02/2003
- Last edited
- 15/08/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Ellen Murray
Scientific
Scientific
Department of Primary Care and General Practice
University of Birmingham
Edgbaston
B15 2TT
United Kingdom
| Phone | +44 (0)121 414 3761 |
|---|---|
| e.t.murray@bham.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | QAASM |
| Study objectives | Aim: To evaluate three different methods of external quality assurance (EQA) for home management. Primary objective: To compare patients' treatment related quality of life in relation to external quality assurance for home anticoagulation management, with or without supervision. Secondary objective: To compare three different methods of EQA, one unsupervised and two supervised in terms of: 1. Reliability of EQA results 2. Impact on international normalised ratio (INR) control 3. Costs associated with each method of EQA |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Anticoagulant therapy |
| Intervention | Patients from the SMART trial (Self-management of warfarin: a randomised trial) will be randomly allocated to two main groups at practice level for supervised or non-supervised External Quality Control (EQA). Twenty-four practices into groups 1 and 2. The practices randomised to supervised EQA will then be further randomly allocated to different methods of supervised EQA, Groups 2A and 2B. Unsupervised group: formal EQA scheme (National Quality Assessment Scheme NEQAS). Supervised groups: International normalised ratio (INR) results from venous samples sent to the local laboratory will be compared with contemporaneous near patient testing (NPT) capillary samples at the practice using the patient's NPT system, or INR results from patient NPT system capillary sample tests will be compared to results from an NPT system weekly quality control tested using samples from NEQAS at the practice, NPT to NPT. |
| Intervention type | Other |
| Primary outcome measure(s) |
Difference in treatment related quality of life scores between non supervised and supervised EQA models |
| Key secondary outcome measure(s) |
1. Comparison of EQA results between three models of EQA |
| Completion date | 31/07/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 260 |
| Key inclusion criteria | 1. Patients aged 18 or over 2. A long term (greater than 12 months) indication for oral anticoagulation 3. Have taken warfarin for at least six months 4. Are willing (or in the case of dependent patients both they and their carer are willing) to participate in the study |
| Key exclusion criteria | 1. Patients with a short-term indication (less than 12 months) for warfarin therapy 2. Aged under 18 years 3. Housebound patients 4. Patients confined to a nursing home |
| Date of first enrolment | 01/08/2000 |
| Date of final enrolment | 31/07/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Primary Care and General Practice
Edgbaston
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 | 01/11/2002 | Yes | No |
