Condition category
Circulatory System
Date applied
05/06/2013
Date assigned
26/09/2013
Last edited
26/09/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Around 60,000 deaths a year in the UK are due to venous thromboembolism (VTE) (a blood clot in a vein), with around 50% of these acquired in hospital. The clinical benefit of treatment to prevent VTE in hospitals is established while in the care home (CH) setting we have little understanding of VTE incidence, or prevention and treatment strategies. CH residents represent a significant public health problem and have a similar risk of developing VTE as hospital in-patients; however, there are few data currently available on the scale of the problem. This study aims to determine for the first time the incidence of VTE among CH residents in the UK.

Who can participate?
Care home residents, male and female, aged 18 years and above.

What does the study involve?
This is an observational study and no treatment will be given or withheld from participants. Participants will undergo a case note review of their care home notes and GP (doctor) medical notes on enrolment and one year after enrolment. Should a participant develop a VTE whilst taking part in the study any treatment given will follow the normal routine as decided by the treating doctor. Participants who die prior to the one-year follow-up will have end of study status and have a notes review following their death.

What are the possible benefits and risks of participating?
This study will help us better understand the incidence of VTE, and prevention and treatment options in CH residents.

Where is the study run from?
Care homes in Birmingham and Oxford will be recruited to the study. GP practices that care for recruited care homes will also be recruited to the study. The study is being organised by a team of researchers from the primary care departments of the University of Birmingham and the University of Oxford (UK).

When is the study starting and how long is it expected to run for?
The study started in August 2013 and will run for 30 months.

Who is funding the study?
The study is funded by the Primary Care Research Trust of Birmingham and Midlands Research Practices Consortium (PCRT), and the NIHR School for Primary Care Research, UK.

Who is the main contact?
Patricia Apenteng
p.n.k.apenteng@bham.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Patricia Apenteng

ORCID ID

Contact details

Primary Care Clinical Sciences
School of Health and Population Sciences
Edgbaston
Birmingham
B15 2TT
United Kingdom
p.n.k.apenteng@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

14555

Study information

Scientific title

A prospective cohort observational study to determine the incidence of venous thromboembolism among care home residents

Acronym

VTEC

Study hypothesis

Around 60,000 deaths a year in the UK are due to venous thromboembolism (VTE) with around 50% of these acquired in hospital. Whilst the clinical benefit of prophylactic treatment for VTE in hospitals is established, in the care home (CH) setting we have little understanding of VTE incidence, or prevention and treatment strategies. CH residents represent a significant public health problem with a similar risk profile to hospital in-patients; however there are few data currently available on the scale of the problem.

This study aims to determine for the first time the incidence of VTE among care home residents in UK. We propose a prospective cohort observational study of consecutive care home residents to determine incidence rates of VTE, VTE related deaths, non-hospital intervention and admissions to hospital.

More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=14555

Ethics approval

Black Country Research Ethics Committee, 06 June 2013, ref 13/WM/0118

Study design

Prospective cohort observational study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Other

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Primary Care Research Network for England; Disease: All Diseases / Venous Thromboembolism

Intervention

Study participants will undergo two case note reviews comprising of a baseline assessment and a follow up assessment one year after enrolment.

The baseline assessment will include data on levels of VTE risk, demographics, mobility index and VTE prevention strategies.

Year one follow up assessment will comprise the index events: hospital admission, non-hospital intervention, diagnosed VTE.

Participants who die prior to the year one follow up will have end of study status and have a notes review following their death. For all deaths research staff will abstract available clinical data from death certificates, nursing home records and hospital discharge letters held in general practitioner (GP) clinical files in order to ascertain whether the event was possibly VTE related.

Follow up length: 12 months

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The rate of VTE events per 100 person years measured 12 months from enrolment

Secondary outcome measures

1. Associated non-hospital interventions
2. Hospital admissions and deaths

Measured 12 months from enrolment

Overall trial start date

01/08/2013

Overall trial end date

30/04/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Care home resident, male and female, aged 18 and above
2. Able to consent (either self or by consultee)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 1000; UK Sample Size: 1000; Description: 1000 care home residents, 500 to be recruited in Birmingham and 500 to be recruited in Oxford.

Participant exclusion criteria

1. Currently participating in clinical trials
2. Residents receiving end of life care with life expectancy < 6 months
3. Temporary residents not expected to stay in the care home for the next 12 months

Recruitment start date

01/08/2013

Recruitment end date

30/04/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Primary Care Clinical Sciences
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

University of Birmingham (UK)

Sponsor details

Department of Primary Care & General Practice
Primary Care Clinical Sciences Building
Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor type

University/education

Website

http://www.birmingham.ac.uk

Funders

Funder type

Government

Funder name

NIHR School for Primary Care Research (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Primary Care Research Trust of Birmingham and Midlands Research Practices Consortium (UK)

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes