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 is given or withheld from participants. Participants 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 follows the normal routine as decided by the treating doctor. Participants who die prior to the one-year follow-up 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?
August 2013 to April 2014
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.
Ethics approval
Black Country Research Ethics Committee, 06/06/2013, 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 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 measure
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 (if study stopped)
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
School of Health and Population 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
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
Basic results (scientific)
Publication list
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28093420