Venous thromboembolism in care homes
| ISRCTN | ISRCTN80889792 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80889792 |
| Protocol serial number | 14555 |
| Sponsor | University of Birmingham (UK) |
| Funders | NIHR School for Primary Care Research (UK), Primary Care Research Trust of Birmingham and Midlands Research Practices Consortium (UK) |
- 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
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
Scientific
Primary Care Clinical Sciences
School of Health and Population Sciences
Edgbaston
Birmingham
B15 2TT
United Kingdom
| p.n.k.apenteng@bham.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective cohort observational study |
| Secondary study design | Cohort study |
| Study type | Participant 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(s) | The rate of VTE events per 100 person years measured 12 months from enrolment |
| Key secondary outcome measure(s) | 1. Associated non-hospital interventions 2. Hospital admissions and deaths Measured 12 months from enrolment |
| Completion date | 30/04/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 1000 |
| 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
- United Kingdom
- England
Study participating centre
B15 2TT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
24/01/2017: Publication reference added.
