<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/NCT03016481</url>
  </required_header>
  <id_info>
    <org_study_id>IHS-1507-31543</org_study_id>
    <nct_id>NCT03016481</nct_id>
  </id_info>
  <brief_title>Realizing Opportunities for Self-Supported Improvement (ROSSI)</brief_title>
  <acronym>ROSE-SAFE</acronym>
  <official_title>Healing Through Education, Advocacy and Law (HEAL) in Response to Violence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Rochester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Rochester</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 is a 3-year comparative effectiveness study funded by the Patient Centered Outcomes&#xD;
      Research Institute (PCORI) and will test an adapted priority-based patient navigation versus&#xD;
      care as usual among 300 survivors of intimate partner violence (IPV) recruited from, and/or&#xD;
      referred from, University of Rochester Medical Center providers. The goal is to improve&#xD;
      patient safety, depression, and health function over the course of 12 months. In the&#xD;
      Community Health Worker -Personalized Support for Progress (CHW-PSP) arm, created and tested&#xD;
      in our first UR PCORI grant, in addition to meeting with a social worker, patients will work&#xD;
      with a Community Health Worker (CHW) to complete a prioritization tool and meet as needed&#xD;
      over the course of the next 6 months to navigate services and overcome barriers. In addition,&#xD;
      patients will receive referrals to other professionals based on their prioritization and meet&#xD;
      with the CHW at the time and place of their choice. Patients in the Care as Usual- Social&#xD;
      Worker (CAU-SW) arm, will do intake with a social worker, who follows hospital procedures for&#xD;
      intake and referrals, does a needs assessment, and offers safety planning in referral.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 15, 2017</start_date>
  <completion_date type="Actual">January 31, 2020</completion_date>
  <primary_completion_date type="Actual">November 30, 2019</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>Patient Safety</measure>
    <time_frame>immediate post intervention (6 months)</time_frame>
    <description>To assess whether CHW-PSP improves patient safety, as compared to CAU-SW Participants will complete the Conflict Tactics Scale-2 a modified from a 20-item self-report measure 10 assessing areas of negotiation, psychological aggression, physical assault, sexual coercion and injury. They will also complete the Danger Assessment, a 20-item measure to assess danger and lethality in a participant's experiences of violence and has documented reliability and validity. We will further assess safety with Steps for Safety instrument.The National Center for State Courts created the 18-item measure to document what safety steps a victim had taken post intervention. We will also receive Rochester Police Department (RPD) 911 call data, which is available to the public, and link the calls to our patients via address geomapping.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Depression</measure>
    <time_frame>9 months</time_frame>
    <description>To assess whether CHW-PSP leads to improved depression and health function post-intervention (9 months). The PHQ-9 is a screen for major depressive disorder with good discriminant validity and sensitivity to change that has been validated in variety of settings.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>12 months</time_frame>
    <description>The effect of the Project Rose-SAFE intervention on the outcome of patient QoL will be mediated by increases in patient safety. The World Health Organization developed the WHOQOL-BREF to assess overall quality of life. It includes 4 summary scales: physical, psychological, social, and environment, plus a total score. The WHOQOL-BREF gives equal attention to the function and to a patient's assessment of the importance of that level of function, was designed to detect change over time, and is associated with change in depression.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">231</enrollment>
  <condition>Domestic Violence</condition>
  <condition>Depression</condition>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>the Community Health Worker -Personalized Support for Progress</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will work with a Community Health Worker (CHW) to complete a prioritization tool and meet as needed over the course of the next 6 months to navigate services and overcome barriers. In addition, patients will receive referrals to other professionals based on their prioritization and meet with the CHW at the time and place of their choice.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Care as Usual- Social Worker</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in the Care as Usual- Social Worker (CAU-SW) arm, will do intake with a social worker, who follows hospital procedures for intake and referrals, does a needs assessment, and offers safety planning in referral.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Active Comparator: the Community Health Worker -Personalized Support for Progress</intervention_name>
    <description>Subjects will meet with their CHW to prioritize their needs detected by the Promote psychosocial screening and identify their preferences for intervention using a secure, online card sorting tool called Optimal Sort. The subject will explain her/his rationale for each decision to the CHW, allowing them both to begin to identify goals. The prioritization survey results provide subjects a personalized package of services that map onto the four main intervention options: legal help, problem solving therapy, medical consultation, or social services.</description>
    <arm_group_label>the Community Health Worker -Personalized Support for Progress</arm_group_label>
    <other_name>CHW-PSP</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Care as Usual- Social Worker</intervention_name>
    <description>Based on their assessment and the subjects' needs, brief onsite interventions are provided and consist of empowerment focused advocacy, IPV education, community referrals, and safety planning. Participants determine follow-up. This will be a short-term interaction as routinely practiced across hospital settings.</description>
    <arm_group_label>Care as Usual- Social Worker</arm_group_label>
    <other_name>CAU-SW</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects must be English speaking URMC patients, who are 18 years of age or older, and/or&#xD;
        the non-offending parent on a CPS report for a URMC pediatrics patient, and who have&#xD;
        experienced an IPV or emotional abuse event within the past 3 months.&#xD;
&#xD;
        IPV is defined as endorsing any of the following items:&#xD;
&#xD;
          1. Slapped, kicked, pushed, choked, or punched?&#xD;
&#xD;
          2. Forced or coerced to have sex?&#xD;
&#xD;
          3. Threatened you with a knife or gun to scare or hurt you?&#xD;
&#xD;
          4. Made you feel afraid that you would be physically hurt?&#xD;
&#xD;
          5. Repeatedly used words, yelled, or screamed in a way that frightened you?&#xD;
&#xD;
          6. Threatened you, put you down, or made you feel rejected? Yes No Additional inclusion&#xD;
             criteria include depression based on PHQ-9 score of &gt;10.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects are ineligible if they have active psychosis or alcohol or substance&#xD;
             dependence based on 3 months threshold on the Mini-International Neuropsychiatric&#xD;
             Interview (MINI).&#xD;
&#xD;
          -  Additionally, patients who are unable to understand the consent form or study&#xD;
             procedures, are imminently suicidal, or are currently working with a CHW will be&#xD;
             excluded.&#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>Catherine Cerulli, JD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Rochester</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Rochester</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14620</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>March 26, 2020</last_update_submitted>
  <last_update_submitted_qc>March 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Rochester</investigator_affiliation>
    <investigator_full_name>Catherine Cerulli</investigator_full_name>
    <investigator_title>Director of Susan B. Anthony Center for Women's Leadership and the Laboratory of Interpersonal Violence and Victimization</investigator_title>
  </responsible_party>
  <!-- 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/NCT03016481
org study id: IHS-1507-31543
nct id: NCT03016481
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a 3-year comparative effectiveness study funded by the Patient Centered Outcomes
      Research Institute (PCORI) and will test an adapted priority-based patient navigation versus
      care as usual among 300 survivors of intimate partner violence (IPV) recruited from, and/or
      referred from, University of Rochester Medical Center providers. The goal is to improve
      patient safety, depression, and health function over the course of 12 months. In the
      Community Health Worker -Personalized Support for Progress (CHW-PSP) arm, created and tested
      in our first UR PCORI grant, in addition to meeting with a social worker, patients will work
      with a Community Health Worker (CHW) to complete a prioritization tool and meet as needed
      over the course of the next 6 months to navigate services and overcome barriers. In addition,
      patients will receive referrals to other professionals based on their prioritization and meet
      with the CHW at the time and place of their choice. Patients in the Care as Usual- Social
      Worker (CAU-SW) arm, will do intake with a social worker, who follows hospital procedures for
      intake and referrals, does a needs assessment, and offers safety planning in referral.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Patient Safety
time frame: immediate post intervention (6 months)
description: To assess whether CHW-PSP improves patient safety, as compared to CAU-SW Participants will complete the Conflict Tactics Scale-2 a modified from a 20-item self-report measure 10 assessing areas of negotiation, psychological aggression, physical assault, sexual coercion and injury. They will also complete the Danger Assessment, a 20-item measure to assess danger and lethality in a participant's experiences of violence and has documented reliability and validity. We will further assess safety with Steps for Safety instrument.The National Center for State Courts created the 18-item measure to document what safety steps a victim had taken post intervention. We will also receive Rochester Police Department (RPD) 911 call data, which is available to the public, and link the calls to our patients via address geomapping.
measure: Depression
time frame: 9 months
description: To assess whether CHW-PSP leads to improved depression and health function post-intervention (9 months). The PHQ-9 is a screen for major depressive disorder with good discriminant validity and sensitivity to change that has been validated in variety of settings.
measure: Quality of Life
time frame: 12 months
description: The effect of the Project Rose-SAFE intervention on the outcome of patient QoL will be mediated by increases in patient safety. The World Health Organization developed the WHOQOL-BREF to assess overall quality of life. It includes 4 summary scales: physical, psychological, social, and environment, plus a total score. The WHOQOL-BREF gives equal attention to the function and to a patient's assessment of the importance of that level of function, was designed to detect change over time, and is associated with change in depression.
arm group label: the Community Health Worker -Personalized Support for Progress
arm group type: Active Comparator
description: Patients will work with a Community Health Worker (CHW) to complete a prioritization tool and meet as needed over the course of the next 6 months to navigate services and overcome barriers. In addition, patients will receive referrals to other professionals based on their prioritization and meet with the CHW at the time and place of their choice.
arm group label: Care as Usual- Social Worker
arm group type: Active Comparator
description: Patients in the Care as Usual- Social Worker (CAU-SW) arm, will do intake with a social worker, who follows hospital procedures for intake and referrals, does a needs assessment, and offers safety planning in referral.
intervention type: Behavioral
intervention name: Active Comparator: the Community Health Worker -Personalized Support for Progress
description: Subjects will meet with their CHW to prioritize their needs detected by the Promote psychosocial screening and identify their preferences for intervention using a secure, online card sorting tool called Optimal Sort. The subject will explain her/his rationale for each decision to the CHW, allowing them both to begin to identify goals. The prioritization survey results provide subjects a personalized package of services that map onto the four main intervention options: legal help, problem solving therapy, medical consultation, or social services.
arm group label: the Community Health Worker -Personalized Support for Progress
other name: CHW-PSP
intervention type: Behavioral
intervention name: Care as Usual- Social Worker
description: Based on their assessment and the subjects' needs, brief onsite interventions are provided and consist of empowerment focused advocacy, IPV education, community referrals, and safety planning. Participants determine follow-up. This will be a short-term interaction as routinely practiced across hospital settings.
arm group label: Care as Usual- Social Worker
other name: CAU-SW
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Catherine Cerulli, JD, PhD
role: Principal Investigator
affiliation: University of Rochester
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Rochester
investigator full name: Catherine Cerulli
investigator title: Director of Susan B. Anthony Center for Women's Leadership and the Laboratory of Interpersonal Violence and Victimization