Title: Improving the prevention and treatment of Venous Thromboembolism in Hospital and the Community
Funder: Department of Health (England)

Abstract: Overarching aims To improve prevention and treatment of thrombosis in the NHS through a series of linked projects. Background Deaths from venous thromboembolism (VTE) in the UK are greater than the combined total deaths from breast cancer, AIDS road traffic accidents and hospital acquired infections. A 2005 UK Health Select Committee report estimated that VTE caused over 25,000 preventable deaths annually with half due to hospital admission. There are no data for similar community populations, eg. nursing home residents. DVT can cause post-thrombotic syndrome, recurrent DVT and pulmonary embolus, with associated morbidity and mortality. Recurrence after first unprovoked DVT can be up to 10% per annum following treatment cessation irrespective of the duration of anticoagulation therapy. Clearly some patients need long-term anticoagulation however we are currently unable to identify this population. Importance of proposed research 1. Thromboprophylaxis remains under-utilised within hospitals. We are yet to understand the scale of the problem within community nursing homes where risk factors are similar to those for hospital in-patients. 2. There is a need for greater understanding of which patients require long term therapy following a first episode of VTE potentially reducing both VTE recurrence and the incidence of post thrombotic syndrome. These data will remain relevant with the advent of new anticoagulants. 3. Education around the area of thromboprophylaxis will become increasingly relevant for primary and secondary care and an understanding of current knowledge as well as existing barriers to implementation of effective management strategies needs to be elucidated. 4. There are no published data available on costs of delivery of VTE care in the UK. It is important therefore to identify different approaches to thromboprophylaxis using existing models of thromboprophylaxis for hospital in-patients and to explore through modelling different approaches to delivery of care for the treatment of VTE. Summary of Previous research by research team leading up to this proposal The research team has an established record in the fields of primary care, thrombosis and haemostasis, cardiovascular disease, health economics, qualitative research and large pragmatic trials. Research Plans WS1: A prospective cohort observational study of consecutive nursing home individuals to determine incidence rates of VTE. WS2: A randomised controlled trial of extended warfarin treatment versus no treatment for the prevention of recurrent VTE and post-thrombotic syndrome in patients being treated for a first episode of unprovoked DVT. WS3: A qualitative study to to explore existing knowledge and barriers to implementing VTE thromboprophylaxis WS4: Determining the cost-effectiveness of thromboprophylaxis and the most cost-effective model of delivery of treatment for patients with VTE. Research Team Birmingham and Oxford are founder members of the National School for Primary Care Research with extensive experience of conducting large community based trials. Programme Management A programme management board comprising the PI (Fitzmaurice), additional WS leads (Heneghan, Greenfield, Ward, Jowett), with additional support (eg; Holder, statistics, Murray, programme manager, Knight, lay person) will meet monthly to ensure satisfactory progress. Each WS will have additional project management with Trial Steering Committees and Data Monitoring Committees appointed as appropriate. Research Environment Primary and secondary care sites supported by the Primary Care Research Network for Central England and the Birmingham and Black Country Comprehensive Local Research Network. Anticipated outputs 1. Understanding training needs for thrombosis risk assessment and provision of thromboprophylaxis at patient, practice, nursing home, hospital and commissioning level 2. Production of multidisciplinary educational material 3. Estimation for the first time of mortality from VTE in nursing homes 4. Production of an algorithm to identify patients requiring long term anticoagulation treatment for DVT 5. Production of cost-effectiveness models for implementation of thromboprophylaxis and for different treatment models for VTE Patient and Public Involvement Mrs Eve Knight, Director of Anticoagulation Europe, has been involved in this programme since its conception and will continue to provide input throughout the lifetime of the programme.. Ethical Implications There are ethical issues surrounding consent within nursing homes for WS1 and treatment of patients with long-term warfarin and the with-holding of treatment for patients with raised d-dimers after cessation of therapy in WS2. Justification of costs The weight of the funding requested is for salaries., principally 3 research fellows, 1 research associate, 3 research nurses, 1 x 0.2 wte statistician and 1 x 0.2 wte health economist. The main non-staff costings are for the d-dimer tests.


Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES;7.3 MANAGEMENT AND DECISION MAKING
Health categories: BLOOD