VTE Prophylaxis Guidelines in Hospitalized Elders

Venous Thromboembolism Clinical Trial

Official title:

Adherence to Venous Thromboembolism Prophylaxis Guidelines in Hospitalized Elders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03025100
• Other study ID #: Pro00056253
• Secondary ID: R03AG048007-01
• Status: Completed
• Start date: February 2016
• Est. completion date: March 4, 2017

Study information

• Verified date: October 2021
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: March 4, 2017
• Est. primary completion date: March 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (5)

Lead Sponsor	Collaborator
Duke University	Hartford Foundation, National Institute on Aging (NIA), National Institutes of Health (NIH), T. Franklin Williams Scholars

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number of minutes of activity (using objective accelerometer data).		Length of hospital stay or up to 7 days during the patient's hospital stay.
Primary	Total number of minutes of inactivity (using objective accelerometer data).		Length of hospital stay or up to 7 days during the patient's hospital stay.
Secondary	Total number of steps (using objective accelerometer data).		Length of hospital stay or up to 7 days during the patient's hospital stay.