<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/NCT03749434</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00155687</org_study_id>
    <nct_id>NCT03749434</nct_id>
  </id_info>
  <brief_title>Understanding and Addressing Variations in HAIs After Durable Ventricular Assist Device Therapy</brief_title>
  <official_title>Understanding and Addressing Variations in Healthcare-associated Infections (HAIs) After Durable Ventricular Assist Device Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Agency for Healthcare Research and Quality (AHRQ)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Substantial center variability exists in healthcare-associated infection (HAI) rates&#xD;
      following durable ventricular assist device (VAD) implantation for patients with advanced&#xD;
      heart failure. Preliminary evidence suggests that this variability may be related to process&#xD;
      (e.g., pre-operative intranasal mupirocin), provider (e.g., surgeon technique, physician&#xD;
      teamwork), device, (e.g., centrifugal vs. axial flow), and center specific (e.g., infection&#xD;
      prevention strategies and resources) factors. The investigators will undertake a mixed&#xD;
      methods study to: (1) identify determinants of center-level variability in HAI rates, (2)&#xD;
      develop a comprehensive understanding of barriers and facilitators for achieving low center&#xD;
      HAI rates, and (3) develop, iteratively enhance, and disseminate a best practices toolkit for&#xD;
      preventing HAIs that accommodates various center contexts.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Durable ventricular assist devices (VADs) provide long-term mechanical circulatory support as&#xD;
      a bridge to cardiac transplantation or as permanent therapy, and have the potential to&#xD;
      benefit more than 250K patients with advanced heart failure (HF) refractory to&#xD;
      guideline-directed medical therapy. Upwards of six out of every 10 VAD patients develop a&#xD;
      healthcare-associated infection (HAI) following implant. Broader adoption of durable VAD&#xD;
      therapy is hindered by HAIs given their association with mortality (5.6-fold increased risk&#xD;
      of 1-year mortality) and healthcare expenditures ($264K - $869K per patient).&#xD;
&#xD;
      Most studies evaluating HAIs in the setting of VAD therapy have been limited to post-hoc&#xD;
      analyses of small trials, or single center experiences. While some argue that centers with&#xD;
      lower HAI rates select healthier patients, others counter that improved practices (e.g.,&#xD;
      standardizing empirical and targeted antimicrobial therapy) or enhanced provider teamwork are&#xD;
      more predictive of improved outcomes. While evidence-based HAI prevention guidelines and&#xD;
      implementation tools (e.g., checklists) exist, these approaches are not comprehensive (e.g.,&#xD;
      neglecting device-specific determinants) or customizable to local context, thus limiting&#xD;
      usability, adoption, and likelihood of significant effectiveness for preventing HAIs.&#xD;
      Understanding the barriers and facilitators within individual centers for maximizing adoption&#xD;
      of prevention measures would serve as the foundation for targeted strategies. Without this&#xD;
      knowledge, evidence-based, action-oriented recommendations will have limited local adoption&#xD;
      and ultimately effectiveness in preventing HAIs after VAD implantation. The investigators'&#xD;
      long-term goal is to develop and subsequently promote wide-scale adoption of evidence-based&#xD;
      HAI prevention practices following durable VAD implantation. The objective of this proposal&#xD;
      is to identify prevention recommendations for the most significant HAIs after VAD&#xD;
      implantation. To achieve this objective, the investigators will undertake a mixed methods&#xD;
      study of adult patients receiving VADs in the U.S. from 2009 - 2017 and develop a modular&#xD;
      toolkit of evidence-based recommendations. To determine best practices for preventing HAIs,&#xD;
      the investigators will examine center-level differences in HAI rates to identify strategies&#xD;
      used by centers with low rates, and barriers to lowering HAI rates among centers with high&#xD;
      rates. The investigators will use a novel dataset including administrative claims and&#xD;
      detailed clinical data, along with in-depth center surveys, to address the following aims:&#xD;
      (i) identify determinants of center-level variability in HAI rates, (ii) develop a&#xD;
      comprehensive understanding of barriers and facilitators for achieving low center HAI rates,&#xD;
      and (iii) develop, iteratively enhance, and disseminate a best practices toolkit for&#xD;
      preventing HAIs that accommodates various center contexts.&#xD;
&#xD;
      These studies will have a positive impact on clinical practice by identifying targets for an&#xD;
      interventional study. Moreover, the mixed methods approach will serve as a model for&#xD;
      evaluating and improving clinical care more broadly - especially in the setting of complex&#xD;
      surgical procedures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 4, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients who have developed a healthcare-associated infection within 90 days following a ventricular assist device (VAD) implant</measure>
    <time_frame>90 days following a VAD implant</time_frame>
    <description>Any healthcare-associated infection within 90 days following a VAD implant</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Type of healthcare-associated infection</measure>
    <time_frame>90 days following a VAD implant</time_frame>
    <description>Healthcare-associated infection subtype</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100000</enrollment>
  <condition>Healthcare-Associated Infections</condition>
  <arm_group>
    <arm_group_label>Adults with HAIs after VAD therapy</arm_group_label>
    <description>Adult patients who have received a ventricular assist device implant.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients who have received a FDA-approved, durable ventricular assist device implant.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female and Male adult patients 18 and over who have received a FDA-approved, durable&#xD;
             ventricular assist device implant from 2008 onwards&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Donald Likosky, PhD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>August 14, 2023</last_update_submitted>
  <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Dr. Donald Likosky</investigator_full_name>
    <investigator_title>Richard and Norma Sarns Research Professor of Cardiac Surgery</investigator_title>
  </responsible_party>
  <keyword>Infections</keyword>
  <keyword>Durable Left Ventricular Assist Device Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Cross Infection</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03749434
org study id: HUM00155687
nct id: NCT03749434
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Substantial center variability exists in healthcare-associated infection (HAI) rates
      following durable ventricular assist device (VAD) implantation for patients with advanced
      heart failure. Preliminary evidence suggests that this variability may be related to process
      (e.g., pre-operative intranasal mupirocin), provider (e.g., surgeon technique, physician
      teamwork), device, (e.g., centrifugal vs. axial flow), and center specific (e.g., infection
      prevention strategies and resources) factors. The investigators will undertake a mixed
      methods study to: (1) identify determinants of center-level variability in HAI rates, (2)
      develop a comprehensive understanding of barriers and facilitators for achieving low center
      HAI rates, and (3) develop, iteratively enhance, and disseminate a best practices toolkit for
      preventing HAIs that accommodates various center contexts.
Durable ventricular assist devices (VADs) provide long-term mechanical circulatory support as
      a bridge to cardiac transplantation or as permanent therapy, and have the potential to
      benefit more than 250K patients with advanced heart failure (HF) refractory to
      guideline-directed medical therapy. Upwards of six out of every 10 VAD patients develop a
      healthcare-associated infection (HAI) following implant. Broader adoption of durable VAD
      therapy is hindered by HAIs given their association with mortality (5.6-fold increased risk
      of 1-year mortality) and healthcare expenditures ($264K - $869K per patient).

      Most studies evaluating HAIs in the setting of VAD therapy have been limited to post-hoc
      analyses of small trials, or single center experiences. While some argue that centers with
      lower HAI rates select healthier patients, others counter that improved practices (e.g.,
      standardizing empirical and targeted antimicrobial therapy) or enhanced provider teamwork are
      more predictive of improved outcomes. While evidence-based HAI prevention guidelines and
      implementation tools (e.g., checklists) exist, these approaches are not comprehensive (e.g.,
      neglecting device-specific determinants) or customizable to local context, thus limiting
      usability, adoption, and likelihood of significant effectiveness for preventing HAIs.
      Understanding the barriers and facilitators within individual centers for maximizing adoption
      of prevention measures would serve as the foundation for targeted strategies. Without this
      knowledge, evidence-based, action-oriented recommendations will have limited local adoption
      and ultimately effectiveness in preventing HAIs after VAD implantation. The investigators'
      long-term goal is to develop and subsequently promote wide-scale adoption of evidence-based
      HAI prevention practices following durable VAD implantation. The objective of this proposal
      is to identify prevention recommendations for the most significant HAIs after VAD
      implantation. To achieve this objective, the investigators will undertake a mixed methods
      study of adult patients receiving VADs in the U.S. from 2009 - 2017 and develop a modular
      toolkit of evidence-based recommendations. To determine best practices for preventing HAIs,
      the investigators will examine center-level differences in HAI rates to identify strategies
      used by centers with low rates, and barriers to lowering HAI rates among centers with high
      rates. The investigators will use a novel dataset including administrative claims and
      detailed clinical data, along with in-depth center surveys, to address the following aims:
      (i) identify determinants of center-level variability in HAI rates, (ii) develop a
      comprehensive understanding of barriers and facilitators for achieving low center HAI rates,
      and (iii) develop, iteratively enhance, and disseminate a best practices toolkit for
      preventing HAIs that accommodates various center contexts.

      These studies will have a positive impact on clinical practice by identifying targets for an
      interventional study. Moreover, the mixed methods approach will serve as a model for
      evaluating and improving clinical care more broadly - especially in the setting of complex
      surgical procedures.
observational model: Case-Only
time perspective: Prospective
measure: Number of patients who have developed a healthcare-associated infection within 90 days following a ventricular assist device (VAD) implant
time frame: 90 days following a VAD implant
description: Any healthcare-associated infection within 90 days following a VAD implant
measure: Type of healthcare-associated infection
time frame: 90 days following a VAD implant
description: Healthcare-associated infection subtype
arm group label: Adults with HAIs after VAD therapy
description: Adult patients who have received a ventricular assist device implant.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Donald Likosky, PhD.
role: Principal Investigator
affiliation: University of Michigan
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Dr. Donald Likosky
investigator title: Richard and Norma Sarns Research Professor of Cardiac Surgery
mesh term: Infections
mesh term: Cross Infection
sharing ipd: No