Venous ThromboembolismNCT03025100
VTE Prophylaxis Guidelines in Hospitalized Elders
An observational study of Venous Thromboembolism, run by Duke University at 1 site in United States.
Trial summary
Guideline directed use of pharmacologic Venous thromboembolism (VTE) prophylaxis emphasizes mobility evaluation. Mobility is a key component of risk stratification. Poor mobility evaluation by providers may be a significant barrier to appropriate use of VTE prophylaxis. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Venous Thromboembolism
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 4 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A sample of patients aged 60 years or older admitted to General Medicine at Duke University Hospital will be enrolled in a prospective cohort study.
Who may be able to join
- Age of 60 or older
- Admitted to General Medicine at Duke University
Who cannot join
- Clear contraindications to pharmacologic VTE prophylaxis
- Receiving surgery during their index hospital stay
- On observation admission status
- On negative pressure room respiratory isolation
- Wrist site is not available, i.e. wearing bilateral wrist IVs, skin breakdown at the time of screening
- Ankle site is not available, i.e. patients with leg ulcer at the time of screening
- Lacking decision-making ability (such as from severe cognitive impairment) and no LAR available
- Non-English speakers
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27701
About this study
Official title: Adherence to Venous Thromboembolism Prophylaxis Guidelines in Hospitalized Elders
Guideline directed use of pharmacologic Venous thromboembolism (VTE) prophylaxis emphasizes mobility evaluation. Mobility is a key component of risk stratification. Poor mobility evaluation by providers may be a significant barrier to appropriate use of VTE prophylaxis. The investigators aim is to propose to determine whether level of mobility during hospitalization is being used to influence use and duration of VTE prophylaxis among medically ill hospitalized elders. To achieve this aim, the investigator will collect prospective observational data to objectively measure inpatient mobility using patient mounted accelerometers during patient hospital stays.
The investigator's goal is to improve the appropriateness of use of VTE prophylaxis among those in which the risks of harm may outweigh the benefit. Results from this study will provide important insights about use of risk assessment, and the relationship between patient mobility and VTE prophylaxis. These results are critical to understanding how to take the next steps toward improving the appropriate use and safety of anticoagulants in hospitalized older adults. Information from this study could be used in future proposals to study interventions to ultimately improve hospital practice in the care of older adults.
- Conditions
- Venous Thromboembolism
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prospective | A sample of 120 patients aged 60 years or older admitted to General Medicine at Duke University Hospital will be enrolled in the prospective cohort study. A convenience sample will be derived from a randomized daily list of general medicine admissions; weekend admissions will be excluded as these patients will not be captured within 24 hours of hospital admission. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of minutes of activity (using objective accelerometer data).
Measured: Length of hospital stay or up to 7 days during the patient's hospital stay.
Total number of minutes of inactivity (using objective accelerometer data).
Measured: Length of hospital stay or up to 7 days during the patient's hospital stay.
Secondary outcomes (1)
Total number of steps (using objective accelerometer data).
Measured: Length of hospital stay or up to 7 days during the patient's hospital stay.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2017 (estimated)
- Study startFeb 2016
- Primary completion4 Mar 2017
- Study completion4 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Hartford Foundation, National Institute on Aging (NIA), T. Franklin Williams Scholars
- Responsible party
- Sponsor
- Investigators
- Juliessa Pavon, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03025100
- Sponsor's protocol ID
- Pro00056253
- Other IDs
- R03AG048007-01
- Status last verified
- Oct 2021
- First submitted
- 17 Jan 2017
- Last updated
- 8 Nov 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to Venous Thromboembolism Prophylaxis Guidelines in Hospitalized Elders
- ClinicalTrials.gov ID
- NCT03025100
- Acronym / sponsor ID
- Pro00056253
- Conditions
- Venous Thromboembolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Hartford Foundation, National Institute on Aging (NIA), T. Franklin Williams Scholars
- Study start
- Feb 2016 (actual)
- Primary completion
- 4 Mar 2017 (actual)
- Study completion
- 4 Mar 2017 (actual)
- First posted
- 19 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Guideline directed use of pharmacologic Venous thromboembolism (VTE) prophylaxis emphasizes mobility evaluation. Mobility is a key component of risk stratification. Poor mobility evaluation by providers may be a significant barrier to appropriate use of VTE prophylaxis. The investigators aim is to propose to determine whether level of mobility during hospitalization is being used to influence use and duration of VTE prophylaxis among medically ill hospitalized elders. To achieve this aim, the investigator will collect prospective observational data to objectively measure inpatient mobility using patient mounted accelerometers during patient hospital stays.
The investigator's goal is to improve the appropriateness of use of VTE prophylaxis among those in which the risks of harm may outweigh the benefit. Results from this study will provide important insights about use of risk assessment, and the relationship between patient mobility and VTE prophylaxis. These results are critical to understanding how to take the next steps toward improving the appropriate use and safety of anticoagulants in hospitalized older adults. Information from this study could be used in future proposals to study interventions to ultimately improve hospital practice in the care of older adults.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective | – | –A sample of 120 patients aged 60 years or older admitted to General Medicine at Duke University Hospital will be enrolled in the prospective cohort study. A convenience sample will be derived from a randomized daily list of general medicine admissions; weekend admissions will be excluded as these patients will not be captured within 24 hours of hospital admission. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A sample of patients aged 60 years or older admitted to General Medicine at Duke University Hospital will be enrolled in a prospective cohort study.
Key inclusion criteria (2 listed)
- Age of 60 or older
- Admitted to General Medicine at Duke University
Key exclusion criteria (8 listed)
- Clear contraindications to pharmacologic VTE prophylaxis
- Receiving surgery during their index hospital stay
- On observation admission status
- On negative pressure room respiratory isolation
- Wrist site is not available, i.e. wearing bilateral wrist IVs, skin breakdown at the time of screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total number of minutes of activity (using objective accelerometer data).
Time frame: Length of hospital stay or up to 7 days during the patient's hospital stay.
Total number of minutes of inactivity (using objective accelerometer data).
Time frame: Length of hospital stay or up to 7 days during the patient's hospital stay.
1 secondary outcome
Total number of steps (using objective accelerometer data).
Time frame: Length of hospital stay or up to 7 days during the patient's hospital stay.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juliessa Pavon principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of minutes of activity (using objective accelerometer data). (time frame: Length of hospital stay or up to 7 days during the patient's hospital stay.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2021; AzTrials last refreshed its copy on 28 Oct 2026.