- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03025100
VTE Prophylaxis Guidelines in Hospitalized Elders
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27701
- Duke University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age of 60 or older
- Admitted to General Medicine at Duke University
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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.
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Length of hospital stay or up to 7 days during the patient's hospital stay.
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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.
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Length of hospital stay or up to 7 days during the patient's hospital stay.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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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.
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Length of hospital stay or up to 7 days during the patient's hospital stay.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Juliessa Pavon, Duke University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00056253
- R03AG048007-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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