Evaluation of two models of delivering anticoagulant care to house bound patients in the community: a multidisciplinary study

ISRCTN	ISRCTN24180077
DOI	https://doi.org/10.1186/ISRCTN24180077
Protocol serial number	N0205114493
Sponsor	Department of Health (UK)
Funder	Barts and The London NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Dita Engova
Scientific

Department of Pharmacy
Homerton University Hospital
Homerton Row
London
E9 6SR
United Kingdom

Phone	+44 (0)20 8510 7002
Email	engovad@lsbu.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Evaluation of two models of delivering anticoagulant care to house bound patients in the community: a multidisciplinary study
Study objectives	We aim to evaluate two models of delivering anticoagulant care to house-bound patients in the community. The study will evaluate the proposed models in terms of patients clinical outcome, patient and professional satisfaction and health economics, and compare them with the traditional hospital-based model.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Anticoagulation therapy
Intervention	Randomised controlled crossover study. Two models of outreach anticoagulation service will be compared with the traditional hospital based model.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	warfarin
Primary outcome measure(s)	1. Clinical: 1.1. Time spent in the therapeutic range. 1.2. The incidence of adverse events (bleeding, thrombotic events) 2. Satisfaction: 2.1. Patients: Consumer Satisfaction Questionnaire (CSQ-8) and 4 structured original questions 2.2. Professionals: semi-structured interview 3. Health economic evaluation
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/03/2004

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	200
Key inclusion criteria	The approximately 200 patients presently anticoagulated with warfarin at Barts and The London NHS Trust anticoagulation clinic with mobility impairment will be invited to participate and consenters randomly assigned to one of the two anticoagulation service provision schemes, i.e. model A followed by model B, or model B followed by model A.
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/10/2002
Date of final enrolment	31/03/2004

Department of Pharmacy

London
E9 6SR
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

13/10/2017: No publications found in PubMed, verifying study status with principal investigator.