Contact information
Type
Scientific
Primary contact
Ms Ellen Murray
ORCID ID
Contact details
Department of Primary Care and General Practice
University of Birmingham
Edgbaston
B15 2TT
United Kingdom
+44 (0)121 414 3761
e.t.murray@bham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G106/970
Study information
Scientific title
Acronym
QAASM
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
Difference in treatment related quality of life scores between non supervised and supervised EQA models
Secondary outcome measures
1. Comparison of EQA results between three models of EQA
2. Comparison of therapeutic INR control in terms of the percentage of time spent within therapeutic range
3. Cost comparison of EQA models
Overall trial start date
01/08/2000
Overall trial end date
31/07/2004
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
260
Participant 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
Recruitment start date
01/08/2000
Recruitment end date
31/07/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Primary Care and General Practice
Edgbaston
B15 2TT
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK) - Special Training Fellowship in HSR
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
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/pubmed/12401823
Publication citations
-
Results
Fitzmaurice DA, Murray ET, Gee KM, Allan TF, Hobbs FD, A randomised controlled trial of patient self management of oral anticoagulation treatment compared with primary care management., J. Clin. Pathol., 2002, 55, 11, 845-849.