<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03025100</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00056253</org_study_id>
    <secondary_id>R03AG048007-01</secondary_id>
    <nct_id>NCT03025100</nct_id>
  </id_info>
  <brief_title>VTE Prophylaxis Guidelines in Hospitalized Elders</brief_title>
  <official_title>Adherence to Venous Thromboembolism Prophylaxis Guidelines in Hospitalized Elders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hartford Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>T. Franklin Williams Scholars</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</source>
  <brief_summary>
    <textblock>
      Guideline directed use of pharmacologic Venous thromboembolism (VTE) prophylaxis emphasizes&#xD;
      mobility evaluation. Mobility is a key component of risk stratification. Poor mobility&#xD;
      evaluation by providers may be a significant barrier to appropriate use of VTE prophylaxis.&#xD;
      The investigators aim is to propose to determine whether level of mobility during&#xD;
      hospitalization is being used to influence use and duration of VTE prophylaxis among&#xD;
      medically ill hospitalized elders. To achieve this aim, the investigator will collect&#xD;
      prospective observational data to objectively measure inpatient mobility using patient&#xD;
      mounted accelerometers during patient hospital stays.&#xD;
&#xD;
      The investigator's goal is to improve the appropriateness of use of VTE prophylaxis among&#xD;
      those in which the risks of harm may outweigh the benefit. Results from this study will&#xD;
      provide important insights about use of risk assessment, and the relationship between patient&#xD;
      mobility and VTE prophylaxis. These results are critical to understanding how to take the&#xD;
      next steps toward improving the appropriate use and safety of anticoagulants in hospitalized&#xD;
      older adults. Information from this study could be used in future proposals to study&#xD;
      interventions to ultimately improve hospital practice in the care of older adults.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2016</start_date>
  <completion_date type="Actual">March 4, 2017</completion_date>
  <primary_completion_date type="Actual">March 4, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Total number of minutes of activity (using objective accelerometer data).</measure>
    <time_frame>Length of hospital stay or up to 7 days during the patient's hospital stay.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Total number of minutes of inactivity (using objective accelerometer data).</measure>
    <time_frame>Length of hospital stay or up to 7 days during the patient's hospital stay.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total number of steps (using objective accelerometer data).</measure>
    <time_frame>Length of hospital stay or up to 7 days during the patient's hospital stay.</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">79</enrollment>
  <condition>Venous Thromboembolism</condition>
  <arm_group>
    <arm_group_label>Prospective</arm_group_label>
    <description>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.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        A sample of patients aged 60 years or older admitted to General Medicine at Duke University&#xD;
        Hospital will be enrolled in a prospective cohort study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age of 60 or older&#xD;
&#xD;
          2. Admitted to General Medicine at Duke University&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Clear contraindications to pharmacologic VTE prophylaxis&#xD;
&#xD;
          2. Receiving surgery during their index hospital stay&#xD;
&#xD;
          3. On observation admission status&#xD;
&#xD;
          4. On negative pressure room respiratory isolation&#xD;
&#xD;
          5. Wrist site is not available, i.e. wearing bilateral wrist IVs, skin breakdown at the&#xD;
             time of screening&#xD;
&#xD;
          6. Ankle site is not available, i.e. patients with leg ulcer at the time of screening&#xD;
&#xD;
          7. Lacking decision-making ability (such as from severe cognitive impairment) and no LAR&#xD;
             available&#xD;
&#xD;
          8. Non-English speakers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Juliessa Pavon</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>November 3, 2021</last_update_submitted>
  <last_update_submitted_qc>November 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thromboembolism</mesh_term>
    <mesh_term>Venous Thromboembolism</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03025100
org study id: Pro00056253
secondary id: R03AG048007-01
nct id: NCT03025100
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
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.
observational model: Cohort
time perspective: Prospective
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.
measure: 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.
measure: 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.
arm group label: Prospective
description: 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.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Juliessa Pavon
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Thromboembolism
mesh term: Venous Thromboembolism