<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/NCT02976025</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00001294</org_study_id>
    <secondary_id>1R01MH108548-01</secondary_id>
    <nct_id>NCT02976025</nct_id>
  </id_info>
  <brief_title>Remote Supervision for Implementing Collaborative Care for Perinatal Depression</brief_title>
  <acronym>MInD-I</acronym>
  <official_title>Remote Supervision for Implementing Collaborative Care for Perinatal Depression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>OCHIN, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Oregon Social Learning Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Washington</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study evaluates the impact of a longitudinal remote consultation (LRC) implementation&#xD;
      strategy for collaborative care depression treatment among perinatal women. All participating&#xD;
      health centers will receive training in collaborative care. Cluster randomization will be&#xD;
      used to assign the addition of LRC to select health centers. Differences in implementation&#xD;
      success, clinical outcomes, and costs will be compared after a 12 month implementation period&#xD;
      and 13-21 month sustainment period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Depression is a common and serious disorder among pregnant women but few from low income&#xD;
      groups receive effective treatment. The highly evidence based collaborative care (CC) model&#xD;
      for depression has been shown to work for women in pregnancy but has not been widely&#xD;
      implemented in this population. The proposed study targets improving dissemination of the&#xD;
      evidence based CC treatment model for pregnant and postpartum women with depression, a common&#xD;
      disorder of the perinatal period (pregnancy and the first year following birth). Longitudinal&#xD;
      remote consultation (LRC) is an implementation strategy that has been have shown to improve&#xD;
      fidelity to evidence-based practices and patient outcomes for mental health innovations. The&#xD;
      investigators believe LRC can be used with equal benefit for complex interventions such as&#xD;
      CC.&#xD;
&#xD;
      The purpose of this study is to compare two implementation strategies for Collaborative Care&#xD;
      depression treatment: 1) standard implementation and 2) standard implementation +&#xD;
      Longitudinal Remote Consultation (LRC). This research is being done in order to assess&#xD;
      implementation and patient outcomes in sites receiving a standard implementation approach&#xD;
      with and without LRC. The results of the proposed study will provide information on the&#xD;
      benefits and relative value of ongoing consultation, such as LRC, for implementation of&#xD;
      complex interventions like collaborative care.&#xD;
&#xD;
      The proposed study will involve twenty health centers providing prenatal care which are part&#xD;
      of the national OCHIN Network or other health center network. All sites will receive a&#xD;
      standard implementation approach. After pre-implementation training ten of the sites will be&#xD;
      randomly selected to receive LRC. Implementation and clinical outcomes as well as costs will&#xD;
      be compared between the study conditions after a 12 month implementation period and a 13-21&#xD;
      month sustainment period. The results of the proposed study will provide critical&#xD;
      generalizable knowledge regarding the benefits of ongoing consultation for implementation of&#xD;
      complex interventions like collaborative care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Anticipated">July 2021</completion_date>
  <primary_completion_date type="Anticipated">July 2021</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical depression outcomes</measure>
    <time_frame>12 months post-initiation of collaborative care</time_frame>
    <description>Patient Health Questionnaire-9 (PHQ-9); level of depression symptomatology and functional impairment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Implementation outcomes</measure>
    <time_frame>12 month post-implementation of collaborative care</time_frame>
    <description>To assess the degree to which sites in the two conditions complete implementation, the investigators will use the Stages of Implementation Completion tool tailored for collaborative care, SIC-CC.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Cost and cost-effectiveness</measure>
    <time_frame>12-month post-implementation of collaborative care</time_frame>
    <description>For a cost-benefit analysis, the investigators will use of the Cost of Implementing New Strategies (COINS) method to assess costs in the two conditions. This methodology takes advantage of the SIC-CC instrument as a costing template to map the use of resources and associated costs to these to study conditions. Costs associated with implementation in each of these conditions will be carried out for all 20 health centers included in the study.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Perinatal Depression</condition>
  <arm_group>
    <arm_group_label>Longitudinal Remote Consultation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This is the active treatment arm consisting of 10 cluster randomized health centers receiving both training in collaborative care and longitudinal remote consultation (LRC) support.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Collaborative Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This comparator arm will consist of 10 cluster randomized health centers who receive training in collaborative care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Longitudinal Remote Consultation</intervention_name>
    <description>Longitudinal Remote Consultation utilizes video conferencing to efficiently link providers to consultants who provide timely feedback and training in collaborative care. LRC will be provided in addition to standard collaborative care training and support.</description>
    <arm_group_label>Longitudinal Remote Consultation</arm_group_label>
    <other_name>LRC</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Collaborative Care</intervention_name>
    <description>Standard collaborative care implementation training and support.</description>
    <arm_group_label>Collaborative Care</arm_group_label>
    <other_name>CC</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Patient Participants:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient participants must be perinatal women,&#xD;
&#xD;
          -  Age 18-45,&#xD;
&#xD;
          -  Receiving care at one of the 20 OCHIN or non-OCHIN health centers participating in the&#xD;
             study and must have major depression as determined by a score of ≥10 on the PHQ-9&#xD;
             depression screener.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18 or &gt;45,&#xD;
&#xD;
          -  Male.&#xD;
&#xD;
        Health Center Participating Sites:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Use of the shared OCHIN Epic electronic record for perinatal care or use of the secure&#xD;
             AIMS CMTS/Caseload Tracker/spreadsheet patient registry for perinatal care and&#xD;
&#xD;
          -  A minimum of 50 prenatal patients annually.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ian Bennett</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>April 27, 2021</last_update_submitted>
  <last_update_submitted_qc>April 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Ian Bennett</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>Asphyxia Neonatorum</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>We intend to share de-identified data once study is complete.</ipd_description>
  </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/NCT02976025
org study id: STUDY00001294
secondary id: 1R01MH108548-01
nct id: NCT02976025
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study evaluates the impact of a longitudinal remote consultation (LRC) implementation
      strategy for collaborative care depression treatment among perinatal women. All participating
      health centers will receive training in collaborative care. Cluster randomization will be
      used to assign the addition of LRC to select health centers. Differences in implementation
      success, clinical outcomes, and costs will be compared after a 12 month implementation period
      and 13-21 month sustainment period.
Depression is a common and serious disorder among pregnant women but few from low income
      groups receive effective treatment. The highly evidence based collaborative care (CC) model
      for depression has been shown to work for women in pregnancy but has not been widely
      implemented in this population. The proposed study targets improving dissemination of the
      evidence based CC treatment model for pregnant and postpartum women with depression, a common
      disorder of the perinatal period (pregnancy and the first year following birth). Longitudinal
      remote consultation (LRC) is an implementation strategy that has been have shown to improve
      fidelity to evidence-based practices and patient outcomes for mental health innovations. The
      investigators believe LRC can be used with equal benefit for complex interventions such as
      CC.

      The purpose of this study is to compare two implementation strategies for Collaborative Care
      depression treatment: 1) standard implementation and 2) standard implementation +
      Longitudinal Remote Consultation (LRC). This research is being done in order to assess
      implementation and patient outcomes in sites receiving a standard implementation approach
      with and without LRC. The results of the proposed study will provide information on the
      benefits and relative value of ongoing consultation, such as LRC, for implementation of
      complex interventions like collaborative care.

      The proposed study will involve twenty health centers providing prenatal care which are part
      of the national OCHIN Network or other health center network. All sites will receive a
      standard implementation approach. After pre-implementation training ten of the sites will be
      randomly selected to receive LRC. Implementation and clinical outcomes as well as costs will
      be compared between the study conditions after a 12 month implementation period and a 13-21
      month sustainment period. The results of the proposed study will provide critical
      generalizable knowledge regarding the benefits of ongoing consultation for implementation of
      complex interventions like collaborative care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Clinical depression outcomes
time frame: 12 months post-initiation of collaborative care
description: Patient Health Questionnaire-9 (PHQ-9); level of depression symptomatology and functional impairment.
measure: Implementation outcomes
time frame: 12 month post-implementation of collaborative care
description: To assess the degree to which sites in the two conditions complete implementation, the investigators will use the Stages of Implementation Completion tool tailored for collaborative care, SIC-CC.
measure: Cost and cost-effectiveness
time frame: 12-month post-implementation of collaborative care
description: For a cost-benefit analysis, the investigators will use of the Cost of Implementing New Strategies (COINS) method to assess costs in the two conditions. This methodology takes advantage of the SIC-CC instrument as a costing template to map the use of resources and associated costs to these to study conditions. Costs associated with implementation in each of these conditions will be carried out for all 20 health centers included in the study.
arm group label: Longitudinal Remote Consultation
arm group type: Experimental
description: This is the active treatment arm consisting of 10 cluster randomized health centers receiving both training in collaborative care and longitudinal remote consultation (LRC) support.
arm group label: Collaborative Care
arm group type: Active Comparator
description: This comparator arm will consist of 10 cluster randomized health centers who receive training in collaborative care.
intervention type: Other
intervention name: Longitudinal Remote Consultation
description: Longitudinal Remote Consultation utilizes video conferencing to efficiently link providers to consultants who provide timely feedback and training in collaborative care. LRC will be provided in addition to standard collaborative care training and support.
arm group label: Longitudinal Remote Consultation
other name: LRC
intervention type: Other
intervention name: Collaborative Care
description: Standard collaborative care implementation training and support.
arm group label: Collaborative Care
other name: CC
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Ian Bennett
role: Principal Investigator
affiliation: University of Washington
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Ian Bennett
investigator title: Professor
mesh term: Asphyxia Neonatorum
mesh term: Depression
mesh term: Depressive Disorder
sharing ipd: Yes
ipd description: We intend to share de-identified data once study is complete.