<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/NCT04499391</url>
  </required_header>
  <id_info>
    <org_study_id>PCORI Nursing Homes</org_study_id>
    <nct_id>NCT04499391</nct_id>
  </id_info>
  <brief_title>COVID-19 Project ECHO in Nursing Homes</brief_title>
  <official_title>COVID-19 Project ECHO for Nursing Homes: A Patient-centered, Randomized-controlled Trial to Implement Infection Control and Quality of Life Best Practice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Milton S. Hershey Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Milton S. Hershey Medical Center</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>
      Nursing homes are ground zero for the COVID-19 pandemic. Nursing homes are ill-equipped for&#xD;
      the pandemic; though facilities are required to have infection control staff, only 3% have&#xD;
      taken a basic infection control course. Significant research has focused on infection control&#xD;
      in the acute care setting. However, little is known about the implementation of practices and&#xD;
      effective interventions in long-term care facilities.The investigators propose an&#xD;
      intervention utilizing Project ECHO, an evidence-based telehealth model, to connect Penn&#xD;
      State University experts with remote nursing home staff and administrators to proactively&#xD;
      support evidence-based infection control guideline implementation. Our study seeks to answer&#xD;
      the critical research question of how evidence-based infection control guidelines can be&#xD;
      implemented effectively in nursing homes&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will recruit 200 nursing homes with approximately 24,560 residents from&#xD;
      across the United States through collaborations with our stakeholders. Nursing homes will be&#xD;
      randomized to one of two arms: 1) AHRQ-funded COVID-19 ECHO that includes 16 weekly&#xD;
      telehealth sessions addressing COVID-19 guidelines and best practices or 2) AHRQ-funded&#xD;
      COVID-19 ECHO plus an additional 9 sessions with a focus on CDC infection control training.&#xD;
      Randomization will be stratified by characteristics of nursing homes to ensure balance among&#xD;
      the two trial groups, including size (number of beds),geographic location, and current&#xD;
      COVID-19 infection rate. Patient-centered outcomes (nursing home residents with COVID-19&#xD;
      infections, hospitalizations, deaths, and QOL) will be assessed at baseline, 4, 6, 12, and 18&#xD;
      months. Our study is guided by the RE-AIM framework to critically evaluate both effectiveness&#xD;
      and implementation outcomes of the proposed intervention. The RE-AIM framework is frequently&#xD;
      utilized to improve sustainable adoption and implementation of effective, generalizable,&#xD;
      evidence-based interventions like Project ECHO.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 4, 2020</start_date>
  <completion_date type="Anticipated">October 2022</completion_date>
  <primary_completion_date type="Anticipated">October 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>stratified cluster randomized design</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Infection rate</measure>
    <time_frame>Baseline, 4, 6, 12, 18 months</time_frame>
    <description>Rate of COVID-19 infection in enrolled nursing homes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospitalization</measure>
    <time_frame>Baseline, 4, 6, 12, 18 months</time_frame>
    <description>Number of COVID-19 hospitalizations from enrolled nursing homes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death</measure>
    <time_frame>Baseline, 4, 6, 12, 18 months</time_frame>
    <description>Number of COVID-19 deaths from enrolled nursing homes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Flu-like illness</measure>
    <time_frame>Baseline, 4, 6, 12, 18 months</time_frame>
    <description>Number of flu-like illnesses reported from enrolled nursing homes</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">136</enrollment>
  <condition>Covid19</condition>
  <arm_group>
    <arm_group_label>ECHO plus</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nursing homes in this arm will receive the intervention via real-time, interactive videoconferencing using Zoom at no cost to participants. Sessions will be 90 minutes in duration and held weekly for 6 months (25 sessions total) at regularly scheduled times. Participants in this arm will receive a 2 month (8 sessions total) refresher course in Fall 2021. Project ECHO utilizes case-based, collaborative learning to support discussion of learners' challenges and barriers to guideline implementation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ECHO</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nursing homes in this arm will receive the intervention via real-time, interactive videoconferencing using Zoom at no cost to participants. Sessions will be 90 minutes in duration and held weekly for 6 months (25 sessions total) at regularly scheduled times. Project ECHO utilizes case-based, collaborative learning to support discussion of learners' challenges and barriers to guideline implementation</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Project ECHO</intervention_name>
    <description>Project ECHO utilizes case-based, collaborative learning to support discussion of learners' challenges and barriers to guideline implementation. This differentiates ECHO from traditional learning and facilitates rapid dissemination of medical knowledge and increased capacity to deliver best-practice care.studying innovative approaches.</description>
    <arm_group_label>ECHO</arm_group_label>
    <arm_group_label>ECHO plus</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for Facilities Skilled Nursing Facility in United States Access to&#xD;
        computer or electronic device&#xD;
&#xD;
        Exclusion Criteria for Facilities Previously participated in Project ECHO COVID-19 series&#xD;
        either through Penn State or another institution&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer Kraschnewski</last_name>
    <role>Principal Investigator</role>
    <affiliation>Penn State College of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jennifer Kraschnewski</last_name>
    <phone>717-531-7778</phone>
    <email>jkraschnewski@pennstatehealth.psu.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Erica Francis</last_name>
    <email>efrancis@psu.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Penn State College of Medicine, Penn State Milton S. Hershey Medical Center</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jennifer L Kraschnewski, MD, MPH</last_name>
      <phone>717-531-0003</phone>
      <phone_ext>283891</phone_ext>
      <email>jkraschnewski@hmc.psu.edu</email>
    </contact>
    <investigator>
      <last_name>Jennifer L Kraschnewski, MD, MPH</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>July 31, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>September 20, 2022</last_update_submitted>
  <last_update_submitted_qc>September 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Milton S. Hershey Medical Center</investigator_affiliation>
    <investigator_full_name>Jennifer Kraschnewski</investigator_full_name>
    <investigator_title>Associate Professor and Vice Chair for Research, Department of Medicine</investigator_title>
  </responsible_party>
  <keyword>Project ECHO</keyword>
  <keyword>telehealth</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>September 27, 2022</submitted>
    <returned>August 18, 2023</returned>
    <submitted>August 22, 2023</submitted>
  </pending_results>
  <!-- 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/NCT04499391
org study id: PCORI Nursing Homes
nct id: NCT04499391
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Nursing homes are ground zero for the COVID-19 pandemic. Nursing homes are ill-equipped for
      the pandemic; though facilities are required to have infection control staff, only 3% have
      taken a basic infection control course. Significant research has focused on infection control
      in the acute care setting. However, little is known about the implementation of practices and
      effective interventions in long-term care facilities.The investigators propose an
      intervention utilizing Project ECHO, an evidence-based telehealth model, to connect Penn
      State University experts with remote nursing home staff and administrators to proactively
      support evidence-based infection control guideline implementation. Our study seeks to answer
      the critical research question of how evidence-based infection control guidelines can be
      implemented effectively in nursing homes
The investigators will recruit 200 nursing homes with approximately 24,560 residents from
      across the United States through collaborations with our stakeholders. Nursing homes will be
      randomized to one of two arms: 1) AHRQ-funded COVID-19 ECHO that includes 16 weekly
      telehealth sessions addressing COVID-19 guidelines and best practices or 2) AHRQ-funded
      COVID-19 ECHO plus an additional 9 sessions with a focus on CDC infection control training.
      Randomization will be stratified by characteristics of nursing homes to ensure balance among
      the two trial groups, including size (number of beds),geographic location, and current
      COVID-19 infection rate. Patient-centered outcomes (nursing home residents with COVID-19
      infections, hospitalizations, deaths, and QOL) will be assessed at baseline, 4, 6, 12, and 18
      months. Our study is guided by the RE-AIM framework to critically evaluate both effectiveness
      and implementation outcomes of the proposed intervention. The RE-AIM framework is frequently
      utilized to improve sustainable adoption and implementation of effective, generalizable,
      evidence-based interventions like Project ECHO.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: stratified cluster randomized design
primary purpose: Prevention
masking: None (Open Label)
measure: Infection rate
time frame: Baseline, 4, 6, 12, 18 months
description: Rate of COVID-19 infection in enrolled nursing homes
measure: Hospitalization
time frame: Baseline, 4, 6, 12, 18 months
description: Number of COVID-19 hospitalizations from enrolled nursing homes
measure: Death
time frame: Baseline, 4, 6, 12, 18 months
description: Number of COVID-19 deaths from enrolled nursing homes
measure: Flu-like illness
time frame: Baseline, 4, 6, 12, 18 months
description: Number of flu-like illnesses reported from enrolled nursing homes
arm group label: ECHO plus
arm group type: Experimental
description: Nursing homes in this arm will receive the intervention via real-time, interactive videoconferencing using Zoom at no cost to participants. Sessions will be 90 minutes in duration and held weekly for 6 months (25 sessions total) at regularly scheduled times. Participants in this arm will receive a 2 month (8 sessions total) refresher course in Fall 2021. Project ECHO utilizes case-based, collaborative learning to support discussion of learners' challenges and barriers to guideline implementation
arm group label: ECHO
arm group type: Active Comparator
description: Nursing homes in this arm will receive the intervention via real-time, interactive videoconferencing using Zoom at no cost to participants. Sessions will be 90 minutes in duration and held weekly for 6 months (25 sessions total) at regularly scheduled times. Project ECHO utilizes case-based, collaborative learning to support discussion of learners' challenges and barriers to guideline implementation
intervention type: Other
intervention name: Project ECHO
description: Project ECHO utilizes case-based, collaborative learning to support discussion of learners' challenges and barriers to guideline implementation. This differentiates ECHO from traditional learning and facilitates rapid dissemination of medical knowledge and increased capacity to deliver best-practice care.studying innovative approaches.
arm group label: ECHO
arm group label: ECHO plus
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jennifer Kraschnewski
role: Principal Investigator
affiliation: Penn State College of Medicine
last name: Jennifer Kraschnewski
phone: 717-531-7778
email: jkraschnewski@pennstatehealth.psu.edu
last name: Erica Francis
email: efrancis@psu.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Milton S. Hershey Medical Center
investigator full name: Jennifer Kraschnewski
investigator title: Associate Professor and Vice Chair for Research, Department of Medicine
mesh term: COVID-19
sharing ipd: No
submitted: September 27, 2022
returned: August 18, 2023
submitted: August 22, 2023