<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/NCT03777241</url>
  </required_header>
  <id_info>
    <org_study_id>182229</org_study_id>
    <nct_id>NCT03777241</nct_id>
  </id_info>
  <brief_title>Disruptive bEhavior manageMEnt ANd Prevention in Hospitalized Patients Using a behaviORal Intervention Team</brief_title>
  <acronym>DEMEANOR</acronym>
  <official_title>Disruptive bEhavior manageMEnt ANd Prevention in Hospitalized Patients Using a behaviORal Intervention Team: Study Protocol for a Pragmatic, Cluster, Cross-over Design</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Vanderbilt University</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>
      The purpose of the proposed study is to evaluate the impact of a behavioral intervention team&#xD;
      (BIT) on 2 adult units: a general medical (8N); a cardiac/medical stepdown (8S) at Vanderbilt&#xD;
      University Medical Center (VUMC) with a higher proportion of patients with behavioral health&#xD;
      comorbidities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The BIT will provide a proactive psychiatric team that will screen all patients on admission,&#xD;
      provide consultation to those meeting established criteria, and recommend interventions to&#xD;
      the primary care team for consideration. BIT will also serve to model therapeutics tactics in&#xD;
      communication and goal setting to the clinical staff.&#xD;
&#xD;
      Research Questions for the proposed study:&#xD;
&#xD;
      Considering that behavioral health co-morbidity is common among hospitalized medical&#xD;
      inpatients and is associated with higher costs of care and staff dissatisfaction, we will&#xD;
      ascertain whether the addition of dedicated, trained behavioral intervention team, compared&#xD;
      to nursing staff training on trauma informed care and de-escalation techniques provides:&#xD;
&#xD;
        1. meaningful, measureable improvement in the prevention and management of disruptive&#xD;
           behavior in the healthcare setting at VUMC, and&#xD;
&#xD;
        2. Improvement in staff perceptions of their ability to manage patients exhibiting&#xD;
           disruptive, threatening or acting out behavior&#xD;
&#xD;
      Specifically, using a pragmatic, cluster cross-over trial design where the BIT crosses&#xD;
      between 8N and 8S, we will test the hypothesis that presence of the BIT results in:&#xD;
&#xD;
        1. Improvement in the prevention and management of patients exhibiting disruptive,&#xD;
           threatening or acting out behavior&#xD;
&#xD;
        2. Improvement in staff perceptions of their ability to manage patients exhibiting&#xD;
           disruptive, threatening or acting out behavior&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Actual">May 11, 2020</completion_date>
  <primary_completion_date type="Actual">February 9, 2020</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent of violence control measures utilized</measure>
    <time_frame>6 months</time_frame>
    <description>By extracting medications, restraints, and sitters ordered from the electronic health records</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent of patient injurious behaviors reported</measure>
    <time_frame>6 months</time_frame>
    <description>By extracting reports of biting, kicking, throwing, etc. from the electronic medical record</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent change in nurse comfort and confidence in their ability to manage patients exhibiting disruptive, threatening or acting out behavior</measure>
    <time_frame>1 year</time_frame>
    <description>By administering surveys to participants</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of unit nursing staff retention</measure>
    <time_frame>1 year</time_frame>
    <description>By extracting rates from internal human resources records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient length of stay</measure>
    <time_frame>6 months</time_frame>
    <description>By extracting data from the electronic health record</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3800</enrollment>
  <condition>Behavioral Problem</condition>
  <arm_group>
    <arm_group_label>Behavioral Intervention Team</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The participants in this arm will receive the Behavioral Intervention Team.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The participants in this arm will receive the standard of care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Behavioral Intervention Team</intervention_name>
    <description>Multidisciplinary team to assist with actively identifying and managing mental illness and substance abuse disorders at their earliest possible time during hospitalization.</description>
    <arm_group_label>Behavioral Intervention Team</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard of care</intervention_name>
    <description>Participants in this group will receive standard of care.</description>
    <arm_group_label>Standard of Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients admitted to two adult medical surgical units (8N/8S) at Vanderbilt&#xD;
             University Medical Center during the study period.&#xD;
&#xD;
          -  All clinical nurses and staff on 8N/8S employed during the study period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients admitted to the floor before the BIT team has begun the crossover period on&#xD;
             the unit.&#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>Ruth Kleinpell, PhD, RN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>September 7, 2020</last_update_submitted>
  <last_update_submitted_qc>September 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University</investigator_affiliation>
    <investigator_full_name>Ruth Kleinpell</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Problem Behavior</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data be available (including data dictionaries) will be shared, particularly individual participant data that underlie the results reported after deidentification.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Immediately following publication. No end date.</ipd_time_frame>
    <ipd_access_criteria>Proposals should be directed to the PI via the Learning Healthcare System platform secondary data use application</ipd_access_criteria>
    <ipd_url>https://redcap.vanderbilt.edu/surveys/?s=CR8TNYXKWX</ipd_url>
  </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/NCT03777241
org study id: 182229
nct id: NCT03777241
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the proposed study is to evaluate the impact of a behavioral intervention team
      (BIT) on 2 adult units: a general medical (8N); a cardiac/medical stepdown (8S) at Vanderbilt
      University Medical Center (VUMC) with a higher proportion of patients with behavioral health
      comorbidities.
The BIT will provide a proactive psychiatric team that will screen all patients on admission,
      provide consultation to those meeting established criteria, and recommend interventions to
      the primary care team for consideration. BIT will also serve to model therapeutics tactics in
      communication and goal setting to the clinical staff.

      Research Questions for the proposed study:

      Considering that behavioral health co-morbidity is common among hospitalized medical
      inpatients and is associated with higher costs of care and staff dissatisfaction, we will
      ascertain whether the addition of dedicated, trained behavioral intervention team, compared
      to nursing staff training on trauma informed care and de-escalation techniques provides:

        1. meaningful, measureable improvement in the prevention and management of disruptive
           behavior in the healthcare setting at VUMC, and

        2. Improvement in staff perceptions of their ability to manage patients exhibiting
           disruptive, threatening or acting out behavior

      Specifically, using a pragmatic, cluster cross-over trial design where the BIT crosses
      between 8N and 8S, we will test the hypothesis that presence of the BIT results in:

        1. Improvement in the prevention and management of patients exhibiting disruptive,
           threatening or acting out behavior

        2. Improvement in staff perceptions of their ability to manage patients exhibiting
           disruptive, threatening or acting out behavior
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Percent of violence control measures utilized
time frame: 6 months
description: By extracting medications, restraints, and sitters ordered from the electronic health records
measure: Percent of patient injurious behaviors reported
time frame: 6 months
description: By extracting reports of biting, kicking, throwing, etc. from the electronic medical record
measure: Percent change in nurse comfort and confidence in their ability to manage patients exhibiting disruptive, threatening or acting out behavior
time frame: 1 year
description: By administering surveys to participants
measure: Rate of unit nursing staff retention
time frame: 1 year
description: By extracting rates from internal human resources records
measure: Patient length of stay
time frame: 6 months
description: By extracting data from the electronic health record
arm group label: Behavioral Intervention Team
arm group type: Active Comparator
description: The participants in this arm will receive the Behavioral Intervention Team.
arm group label: Standard of Care
arm group type: Active Comparator
description: The participants in this arm will receive the standard of care.
intervention type: Behavioral
intervention name: Behavioral Intervention Team
description: Multidisciplinary team to assist with actively identifying and managing mental illness and substance abuse disorders at their earliest possible time during hospitalization.
arm group label: Behavioral Intervention Team
intervention type: Behavioral
intervention name: Standard of care
description: Participants in this group will receive standard of care.
arm group label: Standard of Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ruth Kleinpell, PhD, RN
role: Principal Investigator
affiliation: Vanderbilt University Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University
investigator full name: Ruth Kleinpell
investigator title: Professor
mesh term: Problem Behavior
sharing ipd: Yes
ipd description: Individual participant data be available (including data dictionaries) will be shared, particularly individual participant data that underlie the results reported after deidentification.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Analytic Code
ipd time frame: Immediately following publication. No end date.
ipd access criteria: Proposals should be directed to the PI via the Learning Healthcare System platform secondary data use application
ipd url: https://redcap.vanderbilt.edu/surveys/?s=CR8TNYXKWX