xml: <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/NCT05997836</url>
    </required_header>
    <id_info>
      <org_study_id>QUX 23-002</org_study_id>
      <nct_id>NCT05997836</nct_id>
    </id_info>
    <brief_title>Behavioral Health Interdisciplinary Program - Collaborative Chronic Care Model (BHIP-CCM) Enhancement Project 2.0</brief_title>
    <acronym>BHIP-CCM</acronym>
    <official_title>Behavioral Health Interdisciplinary Program - Collaborative Chronic Care Model (BHIP-CCM) Enhancement Project 2.0 (QUE 20-026)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>VA Office of Research and Development</agency>
        <agency_class>U.S. Fed</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>US Department of Veterans Affairs Office of Mental Health and Suicide Prevention</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>VA Office of Research and Development</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This quality improvement project aims to help outpatient mental health teams, known as&#xD;
        Behavioral Health Interdisciplinary Program (BHIP) teams, adopt more collaborative care&#xD;
        practices (consistent with the collaborative chronic care model or CCM). The investigators&#xD;
        therefore aim to use two different implementation strategies -- centralized technical&#xD;
        assistance and implementation facilitation -- to align BHIP teams' care practices more&#xD;
        closely with the principles of the CCM.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This quality improvement project aims to help outpatient mental health teams, known as&#xD;
        Behavioral Health Interdisciplinary Program (BHIP) teams, adopt more collaborative care&#xD;
        practices (consistent with the collaborative chronic care model or CCM). The investigators&#xD;
        therefore aim to use two different implementation strategies -- centralized technical&#xD;
        assistance and implementation facilitation -- to align BHIP teams' care practices more&#xD;
        closely with the principles of the CCM.&#xD;
  &#xD;
        The two primary outcomes of this project are:&#xD;
  &#xD;
          1. BHIP team collaboration, as evidenced by improved scores in the Role Clarity and Team&#xD;
             Primacy dimensions of the Team Development Measure (TDM)&#xD;
  &#xD;
          2. BHIP team clinical effectiveness, as evidenced by reduction in mental health&#xD;
             hospitalizations among Veterans treated by the BHIP teams that have received the two&#xD;
             types of implementation strategies described above.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 14, 2023</start_date>
    <completion_date type="Anticipated">August 14, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 14, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <intervention_model_description>This study will use a stepped wedge design, with participating medical centers assigned to one of four different waves. Wave 1 will begin the trial receiving implementation facilitation. Waves 2-4 will begin the trial receiving centralized technical assistance, and will then cross over to implementation facilitation.</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Role Clarity and Team Primacy subdomains of the Team Development Measure (TDM)</measure>
      <time_frame>Primary comparison will be between pre-implementation facilitation and post-implementation facilitation (8 months after the pre-implementation administration).</time_frame>
      <description>The TDM is a measure of team functioning, and the two listed subdomains represent the co-primary outcome for the study. Note that, due to the stepped wedge design, only Wave 3 and Wave 4 sites will also have a pre-centralized technical assistance administration of the TDM. Also note that the primary time frame for this outcome, as listed above, will be post-implementation facilitation (8 months after the pre-implementation administration). Secondary analysis will also investigate one year post-implementation facilitation (20 months after the pre-implementation administration).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Mental health hospitalization rate among Veterans treated within each BHIP team.</measure>
      <time_frame>Primary comparison will be between pre-implementation facilitation and post-implementation facilitation (8 months after the pre-implementation administration).</time_frame>
      <description>Mental health hospitalizations represent a measure of clinical effectiveness (co-primary outcome for the study). Note that, due to the stepped wedge design, only Wave 3 and Wave 4 sites will also have a pre-centralized technical assistance calculation of the mental health hospitalization rate. Also note that the primary time frame for this outcome, as listed above, will be post-implementation facilitation (8 months after the pre-implementation administration). Secondary analysis will also investigate one year post-implementation facilitation (20 months after the pre-implementation administration).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Treatment cost</measure>
      <time_frame>Primary comparison will be between pre-implementation facilitation and post-implementation facilitation (8 months after the pre-implementation administration).</time_frame>
      <description>The investigators will calculate estimated treatment costs for Veterans treated by participating BHIP teams. Note that the primary time frame for this outcome, as listed above, will be post-implementation facilitation (8 months after the pre-implementation administration). Secondary analysis will also investigate one year post-implementation facilitation (20 months after the pre-implementation administration).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>All-cause mortality</measure>
      <time_frame>Primary comparison will be between pre-implementation facilitation and post-implementation facilitation (8 months after the pre-implementation administration).</time_frame>
      <description>The investigators will calculate all-cause mortality for Veterans treated by participating BHIP teams. Note that the primary time frame for this outcome, as listed above, will be post-implementation facilitation (8 months after the pre-implementation administration). Secondary analysis will also investigate one year post-implementation facilitation (20 months after the pre-implementation administration).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment costs and hospitalization data compared to non-intervention sites</measure>
      <time_frame>Post-facilitation (8 months after start of implementation facilitation) and post-sustainment (12 months after post-facilitation)</time_frame>
      <description>For mental health hospitalization and treatment costs, the investigators will compare results from intervention sites to other sites that did not undergo implementation facilitation (i.e. sites from outside the trial that are similar to intervention sites on variables like facility complexity and urban/rural location).</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">16000</enrollment>
    <condition>Mental Health</condition>
    <arm_group>
      <arm_group_label>Wave 1</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Study design is a stepped wedge; Wave 1 begins by receiving Implementation Facilitation</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Wave 2</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Study design is a stepped wedge; Wave 2 begins by receiving Centralized Technical Assistance before crossing over to Implementation Facilitation</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Wave 3</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Study design is a stepped wedge; Wave 3 begins by receiving Centralized Technical Assistance before crossing over to Implementation Facilitation</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Wave 4</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Study design is a stepped wedge; Wave 4 begins by receiving Centralized Technical Assistance before crossing over to Implementation Facilitation</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Implementation Facilitation</intervention_name>
      <description>Implementation Facilitation involves and External Facilitator (from outside of the participating medical center) and an Internal Facilitator (from inside the participating medical center) working together to help BHIP teams within the site adopt care practices that are more consistent with the CCM</description>
      <arm_group_label>Wave 1</arm_group_label>
      <arm_group_label>Wave 2</arm_group_label>
      <arm_group_label>Wave 3</arm_group_label>
      <arm_group_label>Wave 4</arm_group_label>
      <other_name>IF</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Centralized Technical Assistance</intervention_name>
      <description>Centralized Technical Assistance involves having external experts available for ad hoc consultation related to collaborative BHIP care practices.</description>
      <arm_group_label>Wave 2</arm_group_label>
      <arm_group_label>Wave 3</arm_group_label>
      <arm_group_label>Wave 4</arm_group_label>
      <other_name>CTA</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Note that treatment assignment will be at the facility level, and given the stepped&#xD;
               wedge design, sites in Waves 2-4 will cross over from Centralized Technical Assistance&#xD;
               to Implementation Facilitation.&#xD;
  &#xD;
            -  At the provider level (for completing the TDM), the primary inclusion criterion is&#xD;
               clinicians working on BHIP Teams at the participating medical centers.&#xD;
  &#xD;
            -  At the patient level (for mental health hospitalizations, costs, and all-cause&#xD;
               mortality), the primary inclusion criterion is Veterans treated by the BHIP teams at&#xD;
               the participating medical centers.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with a diagnosis of dementia in the electronic medical record.&#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>Christopher J. Miller, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Sara J. Landes, PhD MA BA</last_name>
      <role>Principal Investigator</role>
      <affiliation>Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Christopher J Miller, PhD</last_name>
      <phone>(857) 364-5688</phone>
      <email>Christopher.Miller8@va.gov</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Madisen E Brown</last_name>
      <phone>(617) 232-9500</phone>
      <email>Madisen.Brown@va.gov</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>VA Palo Alto Health Care System, Palo Alto, CA</name>
        <address>
          <city>Palo Alto</city>
          <state>California</state>
          <zip>94304-1207</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Michael DiMarco, PhD</last_name>
        <phone>000-000-0000</phone>
        <email>michael.dimarco@va.gov</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>VA Greater Los Angeles Healthcare System, West Los Angeles, CA</name>
        <address>
          <city>West Los Angeles</city>
          <state>California</state>
          <zip>90073-1003</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Charles Deleeuw, PhD</last_name>
        <phone>000-000-0000</phone>
        <email>charles.deleeuw@va.gov</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Orlando VA Medical Center, Orlando, FL</name>
        <address>
          <city>Orlando</city>
          <state>Florida</state>
          <zip>32827</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Jennifer Conaway, RN</last_name>
        <phone>000-000-0000</phone>
        <email>jennifer.conaway@va.gov</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Richard L. Roudebush VA Medical Center, Indianapolis, IN</name>
        <address>
          <city>Indianapolis</city>
          <state>Indiana</state>
          <zip>46202-2884</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Shannon Woller, PhD</last_name>
        <phone>000-000-0000</phone>
        <email>shannon.woller@va.gov</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02130-4817</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mieke Verfaellie, PhD</last_name>
        <email>mieke.verfaellie@va.gov</email>
      </contact>
      <contact_backup>
        <last_name>Denise M Sloan, PhD</last_name>
        <phone>(857) 364-6333</phone>
        <email>Denise.Sloan@va.gov</email>
      </contact_backup>
      <investigator>
        <last_name>Christopher J. Miller, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>West Texas VA Health Care System, Big Spring, TX</name>
        <address>
          <city>Big Spring</city>
          <state>Texas</state>
          <zip>79720</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ari Lowell, PhD</last_name>
        <phone>000-000-0000</phone>
        <email>ari.lowell@va.gov</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>White River Junction VA Medical Center, White River Junction, VT</name>
        <address>
          <city>White River Junction</city>
          <state>Vermont</state>
          <zip>05001-3833</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Max Winer, LCSW-C</last_name>
        <phone>000-000-0000</phone>
        <email>max.winer@va.gov</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Salem VA Medical Center, Salem, VA</name>
        <address>
          <city>Salem</city>
          <state>Virginia</state>
          <zip>24153-6404</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Stephen Lash, PhD</last_name>
        <phone>000-000-0000</phone>
        <email>steven.lash@va.gov</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Clarksburg Louis A. Johnson VA Medical Center, Clarksburg, WV</name>
        <address>
          <city>Clarksburg</city>
          <state>West Virginia</state>
          <zip>26301-4155</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Shannon Fragmin, RN</last_name>
        <phone>000-000-0000</phone>
        <email>shannon.fragmin@va.gov</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>collaborative care</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05997836
  org study id: QUX 23-002
  nct id: NCT05997836
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  This quality improvement project aims to help outpatient mental health teams, known as
        Behavioral Health Interdisciplinary Program (BHIP) teams, adopt more collaborative care
        practices (consistent with the collaborative chronic care model or CCM). The investigators
        therefore aim to use two different implementation strategies -- centralized technical
        assistance and implementation facilitation -- to align BHIP teams' care practices more
        closely with the principles of the CCM.
  This quality improvement project aims to help outpatient mental health teams, known as
        Behavioral Health Interdisciplinary Program (BHIP) teams, adopt more collaborative care
        practices (consistent with the collaborative chronic care model or CCM). The investigators
        therefore aim to use two different implementation strategies -- centralized technical
        assistance and implementation facilitation -- to align BHIP teams' care practices more
        closely with the principles of the CCM.
  
        The two primary outcomes of this project are:
  
          1. BHIP team collaboration, as evidenced by improved scores in the Role Clarity and Team
             Primacy dimensions of the Team Development Measure (TDM)
  
          2. BHIP team clinical effectiveness, as evidenced by reduction in mental health
             hospitalizations among Veterans treated by the BHIP teams that have received the two
             types of implementation strategies described above.
  allocation: Non-Randomized
  intervention model: Crossover Assignment
  intervention model description: This study will use a stepped wedge design, with participating medical centers assigned to one of four different waves. Wave 1 will begin the trial receiving implementation facilitation. Waves 2-4 will begin the trial receiving centralized technical assistance, and will then cross over to implementation facilitation.
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Role Clarity and Team Primacy subdomains of the Team Development Measure (TDM)
  time frame: Primary comparison will be between pre-implementation facilitation and post-implementation facilitation (8 months after the pre-implementation administration).
  description: The TDM is a measure of team functioning, and the two listed subdomains represent the co-primary outcome for the study. Note that, due to the stepped wedge design, only Wave 3 and Wave 4 sites will also have a pre-centralized technical assistance administration of the TDM. Also note that the primary time frame for this outcome, as listed above, will be post-implementation facilitation (8 months after the pre-implementation administration). Secondary analysis will also investigate one year post-implementation facilitation (20 months after the pre-implementation administration).
  measure: Mental health hospitalization rate among Veterans treated within each BHIP team.
  time frame: Primary comparison will be between pre-implementation facilitation and post-implementation facilitation (8 months after the pre-implementation administration).
  description: Mental health hospitalizations represent a measure of clinical effectiveness (co-primary outcome for the study). Note that, due to the stepped wedge design, only Wave 3 and Wave 4 sites will also have a pre-centralized technical assistance calculation of the mental health hospitalization rate. Also note that the primary time frame for this outcome, as listed above, will be post-implementation facilitation (8 months after the pre-implementation administration). Secondary analysis will also investigate one year post-implementation facilitation (20 months after the pre-implementation administration).
  measure: Treatment cost
  time frame: Primary comparison will be between pre-implementation facilitation and post-implementation facilitation (8 months after the pre-implementation administration).
  description: The investigators will calculate estimated treatment costs for Veterans treated by participating BHIP teams. Note that the primary time frame for this outcome, as listed above, will be post-implementation facilitation (8 months after the pre-implementation administration). Secondary analysis will also investigate one year post-implementation facilitation (20 months after the pre-implementation administration).
  measure: All-cause mortality
  time frame: Primary comparison will be between pre-implementation facilitation and post-implementation facilitation (8 months after the pre-implementation administration).
  description: The investigators will calculate all-cause mortality for Veterans treated by participating BHIP teams. Note that the primary time frame for this outcome, as listed above, will be post-implementation facilitation (8 months after the pre-implementation administration). Secondary analysis will also investigate one year post-implementation facilitation (20 months after the pre-implementation administration).
  measure: Treatment costs and hospitalization data compared to non-intervention sites
  time frame: Post-facilitation (8 months after start of implementation facilitation) and post-sustainment (12 months after post-facilitation)
  description: For mental health hospitalization and treatment costs, the investigators will compare results from intervention sites to other sites that did not undergo implementation facilitation (i.e. sites from outside the trial that are similar to intervention sites on variables like facility complexity and urban/rural location).
  arm group label: Wave 1
  arm group type: Other
  description: Study design is a stepped wedge; Wave 1 begins by receiving Implementation Facilitation
  arm group label: Wave 2
  arm group type: Other
  description: Study design is a stepped wedge; Wave 2 begins by receiving Centralized Technical Assistance before crossing over to Implementation Facilitation
  arm group label: Wave 3
  arm group type: Other
  description: Study design is a stepped wedge; Wave 3 begins by receiving Centralized Technical Assistance before crossing over to Implementation Facilitation
  arm group label: Wave 4
  arm group type: Other
  description: Study design is a stepped wedge; Wave 4 begins by receiving Centralized Technical Assistance before crossing over to Implementation Facilitation
  intervention type: Other
  intervention name: Implementation Facilitation
  description: Implementation Facilitation involves and External Facilitator (from outside of the participating medical center) and an Internal Facilitator (from inside the participating medical center) working together to help BHIP teams within the site adopt care practices that are more consistent with the CCM
  arm group label: Wave 1
  arm group label: Wave 2
  arm group label: Wave 3
  arm group label: Wave 4
  other name: IF
  intervention type: Other
  intervention name: Centralized Technical Assistance
  description: Centralized Technical Assistance involves having external experts available for ad hoc consultation related to collaborative BHIP care practices.
  arm group label: Wave 2
  arm group label: Wave 3
  arm group label: Wave 4
  other name: CTA
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Christopher J. Miller, PhD
  role: Principal Investigator
  affiliation: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
  last name: Sara J. Landes, PhD MA BA
  role: Principal Investigator
  affiliation: Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
  last name: Christopher J Miller, PhD
  phone: (857) 364-5688
  email: Christopher.Miller8@va.gov
  last name: Madisen E Brown
  phone: (617) 232-9500
  email: Madisen.Brown@va.gov
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: No