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
Secondary identifying numbers G106/970
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

Department of Primary Care and General Practice
University of Birmingham
Edgbaston
B15 2TT
United Kingdom

Phone +44 (0)121 414 3761
Email e.t.murray@bham.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study acronymQAASM
Study objectivesAim:
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) studiedAnticoagulant therapy
InterventionPatients 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 typeOther
Primary outcome measureDifference in treatment related quality of life scores between non supervised and supervised EQA models
Secondary outcome measures1. 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 study start date01/08/2000
Completion date31/07/2004

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants260
Key inclusion criteria1. 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 criteria1. 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 enrolment01/08/2000
Date of final enrolment31/07/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Primary Care and General Practice
Edgbaston
B15 2TT
United Kingdom

Sponsor information

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone +44 (0)20 7636 5422
Email clinical.trial@headoffice.mrc.ac.uk
Website http://www.mrc.ac.uk

Funders

Funder type

Research council

Medical Research Council (MRC) (UK) - Special Training Fellowship in HSR

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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