VTE Prophylaxis Guidelines in Hospitalized Elders

NCT ID: NCT03025100

Last Updated: 2021-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

79 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-03-04

Brief Summary

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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.

Detailed Description

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Conditions

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Venous Thromboembolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Age of 60 or older
2. Admitted to General Medicine at Duke University

Exclusion Criteria

1. Clear contraindications to pharmacologic VTE prophylaxis
2. Receiving surgery during their index hospital stay
3. On observation admission status
4. On negative pressure room respiratory isolation
5. Wrist site is not available, i.e. wearing bilateral wrist IVs, skin breakdown at the time of screening
6. Ankle site is not available, i.e. patients with leg ulcer at the time of screening
7. Lacking decision-making ability (such as from severe cognitive impairment) and no LAR available
8. Non-English speakers
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Hartford Foundation

OTHER

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

T. Franklin Williams Scholars

UNKNOWN

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Juliessa Pavon

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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R03AG048007-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00056253

Identifier Type: -

Identifier Source: org_study_id