Venous thromboembolism in care homes

ISRCTN	ISRCTN80889792
DOI	https://doi.org/10.1186/ISRCTN80889792
Secondary identifying numbers	14555

Submission date: 05/06/2013
Registration date: 26/09/2013
Last edited: 24/01/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Mrs Patricia Apenteng
Scientific

Primary Care Clinical Sciences
School of Health and Population Sciences
Edgbaston
Birmingham
B15 2TT
United Kingdom

Email	p.n.k.apenteng@bham.ac.uk

Study information

Study design	Prospective cohort observational study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Other
Study type	Screening
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	A prospective cohort observational study to determine the incidence of venous thromboembolism among care home residents
Study acronym	VTEC
Study objectives	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(s)	Black Country Research Ethics Committee, 06/06/2013, ref: 13/WM/0118
Health condition(s) or problem(s) studied	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
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 study start date	01/08/2013
Completion date	30/04/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	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.
Key inclusion criteria	1. Care home resident, male and female, aged 18 and above 2. Able to consent (either self or by consultee)
Key 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
Date of first enrolment	01/08/2013
Date of final enrolment	30/04/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

School of Health and Population Sciences

Birmingham
B15 2TT
United Kingdom

Sponsor information

University of Birmingham (UK)
University/education

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

Website	http://www.birmingham.ac.uk
"ROR"	https://ror.org/03angcq70

Funders

Funder type

Government

NIHR School for Primary Care Research (UK)

No information available

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2017		Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

24/01/2017: Publication reference added.