<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/NCT02222909</url>
  </required_header>
  <id_info>
    <org_study_id>CD-12-11-4948</org_study_id>
    <nct_id>NCT02222909</nct_id>
  </id_info>
  <brief_title>Reverse Innovation and Patient Engagement to Improve Quality of Care and Patient Outcomes</brief_title>
  <acronym>CONNECT</acronym>
  <official_title>Reverse Innovation and Patient Engagement to Improve Quality of Care and Patient Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins Bloomberg School of Public Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins Bloomberg School of Public Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Project CONNECT (&quot;Community-based Organizations Neighborhood Network: Enhancing Capacity&#xD;
      Together&quot;) is a randomized controlled trial that involves 22 community-based organizations&#xD;
      (CBOs) located in Baltimore, MD. Half of these organizations were randomly assigned to the&#xD;
      intervention group using a constrained cluster randomization process. The remaining 11 are a&#xD;
      part of the control intervention group. The intervention is a co-developed set of IT tools&#xD;
      hypothesized to improve the connections among intervention CBOs, Johns Hopkins health care&#xD;
      facilities and CBO clients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      see above&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>April 2014</start_date>
  <completion_date type="Anticipated">November 2015</completion_date>
  <primary_completion_date type="Anticipated">November 2015</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>Emergency Department visits + hospital days</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Number of Emergency Department Visits + Number of Hospital Days in the past 6 months for patients enrolled in the Johns Hopkins Community Partnership</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in number of clients seen per month</measure>
    <time_frame>September 2014 - September 2015</time_frame>
    <description>Change in median number of clients seen by Community Based Organizations per month</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Diabetes</condition>
  <condition>Cardiovascular Disease</condition>
  <condition>Substance Abuse Disorder</condition>
  <condition>Mental Health Disorder</condition>
  <arm_group>
    <arm_group_label>Intervention CBOs</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Will receive &quot;co-developed IT intervention&quot; developed together with intervention group community based members. Set of primarily web based tools to improve connection with clients, Johns Hopkins Medicine and one another, referrals, and volunteer services.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control CBOs</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Community Based Organizations that are being followed for data collection only for the period of one year</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Co-developed IT intervention</intervention_name>
    <description>The IT-based intervention is being co-developed with the community based organizations in the intervention group, and comprises tools to improve referral and tracking of clients, use of volunteers, and direct communication with hospital staff members</description>
    <arm_group_label>Intervention CBOs</arm_group_label>
    <other_name>Healthify</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Community Based Organization; 501-C3 status; Located within zip codes surrounding Johns&#xD;
        Hopkins Hospital and Johns Hopkins Bayview Medical Center; Provides direct services to&#xD;
        clients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Part of Johns Hopkins Medicine or Baltimore City Agency&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Albert W Wu, MD MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins Bloomberg School of Public Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zip codes surrounding Johns Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <last_update_submitted>August 20, 2014</last_update_submitted>
  <last_update_submitted_qc>August 20, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Community Based Organization</keyword>
  <keyword>Reverse Innovation</keyword>
  <keyword>Social Services</keyword>
  <keyword>Referral</keyword>
  <keyword>Chronic disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Substance-Related Disorders</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>April 3, 2017</submitted>
    <returned>June 16, 2017</returned>
    <submitted>June 9, 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/NCT02222909
org study id: CD-12-11-4948
nct id: NCT02222909
lead sponsor: 
collaborator: 
has dmc: No
Project CONNECT ("Community-based Organizations Neighborhood Network: Enhancing Capacity
      Together") is a randomized controlled trial that involves 22 community-based organizations
      (CBOs) located in Baltimore, MD. Half of these organizations were randomly assigned to the
      intervention group using a constrained cluster randomization process. The remaining 11 are a
      part of the control intervention group. The intervention is a co-developed set of IT tools
      hypothesized to improve the connections among intervention CBOs, Johns Hopkins health care
      facilities and CBO clients.
see above
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Emergency Department visits + hospital days
time frame: Up to 1 year
description: Number of Emergency Department Visits + Number of Hospital Days in the past 6 months for patients enrolled in the Johns Hopkins Community Partnership
measure: Change in number of clients seen per month
time frame: September 2014 - September 2015
description: Change in median number of clients seen by Community Based Organizations per month
arm group label: Intervention CBOs
arm group type: Experimental
description: Will receive "co-developed IT intervention" developed together with intervention group community based members. Set of primarily web based tools to improve connection with clients, Johns Hopkins Medicine and one another, referrals, and volunteer services.
arm group label: Control CBOs
arm group type: No Intervention
description: Community Based Organizations that are being followed for data collection only for the period of one year
intervention type: Other
intervention name: Co-developed IT intervention
description: The IT-based intervention is being co-developed with the community based organizations in the intervention group, and comprises tools to improve referral and tracking of clients, use of volunteers, and direct communication with hospital staff members
arm group label: Intervention CBOs
other name: Healthify
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Albert W Wu, MD MPH
role: Principal Investigator
affiliation: Johns Hopkins Bloomberg School of Public Health
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
mesh term: Substance-Related Disorders
mesh term: Mental Disorders
submitted: April 3, 2017
returned: June 16, 2017
submitted: June 9, 2023