<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/NCT03259646</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00090497</org_study_id>
    <secondary_id>6 ASTWH150032-01</secondary_id>
    <nct_id>NCT03259646</nct_id>
  </id_info>
  <brief_title>The IPV Provider Network: Engaging the Health Care Provider Response to Interpersonal Violence Against Women</brief_title>
  <official_title>The IPV Provider Network: Engaging the Health Care Provider Response to Interpersonal Violence Against Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Office of Research on Women's Health (ORWH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Futures Without Violence</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins University</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>
      Violence against women is a major public health threat that carries significant consequences&#xD;
      for women's health. Moreover, women experiencing intimate partner violence (IPV) and sexual&#xD;
      assault (SA) are more likely than non-abused women to seek certain forms of health services,&#xD;
      such as for sexually transmitted infections, chronic pain and illnesses, depression and/or&#xD;
      pregnancy-related concerns. As a result, the health sector is an ideal setting to identify&#xD;
      and support survivors. The U.S. Institute of Medicine has identified the health care system,&#xD;
      including the public health infrastructure, as key for identification of and support for&#xD;
      survivors of violence, as well as for violence prevention. While some evidence-based models&#xD;
      exist, no current national consensus has been reached on scalable best practices in screening&#xD;
      and brief counseling for IPV/SA.&#xD;
&#xD;
      This multi-level intervention includes integrating into the clinic setting IPV/SA screening,&#xD;
      universal education, trauma informed counseling, warm referrals (e.g. provider/staff contact&#xD;
      advocacy program with survivor) to local IPV/SA advocacy agencies, and access to the&#xD;
      evidence-based myPlan safety decision aid app. The evaluation, using a cluster randomized&#xD;
      trial design, will measure longitudinal outcomes (over 6 months) of patient self-efficacy,&#xD;
      health and safety outcomes, as well as participant and provider perceptions of the&#xD;
      intervention and clinic level changes in primary and reproductive health clinics in four&#xD;
      states (Arizona, Massachusetts, Pennsylvania and West Virginia) to achieve the following&#xD;
      aims:&#xD;
&#xD;
      Aim 1. Evaluate the effectiveness of an evidence-based screening, universal education and&#xD;
      trauma-informed counseling with tailored safety action plan and referrals to partner IPV/SA&#xD;
      programs compared to standard practice, on survivor health and safety outcomes over a&#xD;
      cumulative period of six months.&#xD;
&#xD;
      Aim 2. Examine longitudinal changes in clinic-level screening, universal education, trauma&#xD;
      informed counseling, safety action plans and referrals to on-site and/or partner IPV/SA&#xD;
      programs and improved standards for documentation through the electronic health record (EHR)&#xD;
      and continuous quality measurement and reporting.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 26, 2017</start_date>
  <completion_date type="Actual">April 25, 2019</completion_date>
  <primary_completion_date type="Actual">April 25, 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>
    <intervention_model_description>cluster randomized trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in use of safety behaviors</measure>
    <time_frame>6 months</time_frame>
    <description>Measured by percent of safety behaviors the woman has tried and found helpful on the Safety Behaviors Checklist. The checklist was adapted from Sullivan and colleagues and Parker and colleagues. Includes use of community resources and safety steps (e.g. asked for help, hidden emergency money) and use of formal services (e.g., women's shelter, protection order, mental health services).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Self-Efficacy to Use Harm Reduction Strategies</measure>
    <time_frame>6 months</time_frame>
    <description>Measure adapted from Tancredi et al and Hibbard et al, assesses confidence to seek help for abuse, if needed, from a health care provider.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Provider Behavior</measure>
    <time_frame>Baseline</time_frame>
    <description>Clinic level measure. Provider Behavior at Visit Survey items administered after the provider visit to assess the provider's adherence to universal education intervention, i.e. discussing healthy and unhealthy relationships during the visit, and referring to resources.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in decisional conflict</measure>
    <time_frame>6 months</time_frame>
    <description>We have adapted questions from validated subscales of the Decisional Conflict Scale as a measure of decision process. Measures whether the intervention helps a woman to understand the advantages and disadvantages of safety planning options and to know her values related to them. The Decisional Conflict Scale discriminates between people who make decisions and those who delay making decisions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Readiness to Take Action</measure>
    <time_frame>6 months</time_frame>
    <description>0-10 scale of readiness to make changes to relationship for safety</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">6272</enrollment>
  <condition>Violence, Domestic</condition>
  <condition>Violence, Sexual</condition>
  <arm_group>
    <arm_group_label>Universal Education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Train providers to integrate screening, universal education, trauma informed counseling, and mobile health (mHealth) technology through the myPlan app safety decision aid in collaboration with local IPV programs as well as the integration of documentation and quality improvement templates and measures into clinical settings.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Practice</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard clinical practice</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Universal Education</intervention_name>
    <description>Clinic provider/staff training on implementing universal education into clinical practice to: 1.) provide all women information about IPV/SA, harm reduction, and available safety resources; 2) provide trauma-informed counseling to women who disclose IPV/SA; includes access to the myPlan safety decision aid to develop a tailored safety action plan; 3) provide warm referrals in partnership with local domestic violence and sexual assault (DV/SA) advocacy agencies; 4) integrate documentation and quality improvement templates and measures into clinical settings.</description>
    <arm_group_label>Universal Education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Seeking healthcare at one of 14 partner clinics&#xD;
&#xD;
          -  Ability to complete a survey on a device (computer/tablet/smartphone in English or&#xD;
             Spanish)&#xD;
&#xD;
          -  Access to safe device (as defined above) if doing surveys online&#xD;
&#xD;
          -  Has a safe email address or safe phone number&#xD;
&#xD;
          -  Is not acutely ill&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Male&#xD;
&#xD;
          -  Not seeking healthcare at one of 9 partner clinics&#xD;
&#xD;
          -  Younger than 18 years of age&#xD;
&#xD;
          -  Older than 59 years of age&#xD;
&#xD;
          -  Cannot read/speak English or Spanish&#xD;
&#xD;
          -  No access to safe device if doing surveys online&#xD;
&#xD;
          -  Does not have a safe email address or safe phone number&#xD;
&#xD;
          -  Acutely ill&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Cis-gender or trans-gender women.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>59 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nancy Glass, PhD, MPH, RN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>North County HealthCare</name>
      <address>
        <city>Kingman</city>
        <state>Arizona</state>
        <zip>86401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Country HealthCare</name>
      <address>
        <city>Lake Havasu City</city>
        <state>Arizona</state>
        <zip>86403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Country HealthCare</name>
      <address>
        <city>Williams</city>
        <state>Arizona</state>
        <zip>86046</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Partners Health Care Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Magee-Women's Hospital of UPMC</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's Health Center</name>
      <address>
        <city>Charleston</city>
        <state>West Virginia</state>
        <zip>25302</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valley Health</name>
      <address>
        <city>Mill Creek</city>
        <state>West Virginia</state>
        <zip>26280</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Greenbrier Co. Health Dept</name>
      <address>
        <city>Ronceverte</city>
        <state>West Virginia</state>
        <zip>24970</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FamilyCare Health Center</name>
      <address>
        <city>Scott Depot</city>
        <state>West Virginia</state>
        <zip>25560</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>January 16, 2020</last_update_submitted>
  <last_update_submitted_qc>January 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03259646
org study id: IRB00090497
secondary id: 6 ASTWH150032-01
nct id: NCT03259646
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Violence against women is a major public health threat that carries significant consequences
      for women's health. Moreover, women experiencing intimate partner violence (IPV) and sexual
      assault (SA) are more likely than non-abused women to seek certain forms of health services,
      such as for sexually transmitted infections, chronic pain and illnesses, depression and/or
      pregnancy-related concerns. As a result, the health sector is an ideal setting to identify
      and support survivors. The U.S. Institute of Medicine has identified the health care system,
      including the public health infrastructure, as key for identification of and support for
      survivors of violence, as well as for violence prevention. While some evidence-based models
      exist, no current national consensus has been reached on scalable best practices in screening
      and brief counseling for IPV/SA.

      This multi-level intervention includes integrating into the clinic setting IPV/SA screening,
      universal education, trauma informed counseling, warm referrals (e.g. provider/staff contact
      advocacy program with survivor) to local IPV/SA advocacy agencies, and access to the
      evidence-based myPlan safety decision aid app. The evaluation, using a cluster randomized
      trial design, will measure longitudinal outcomes (over 6 months) of patient self-efficacy,
      health and safety outcomes, as well as participant and provider perceptions of the
      intervention and clinic level changes in primary and reproductive health clinics in four
      states (Arizona, Massachusetts, Pennsylvania and West Virginia) to achieve the following
      aims:

      Aim 1. Evaluate the effectiveness of an evidence-based screening, universal education and
      trauma-informed counseling with tailored safety action plan and referrals to partner IPV/SA
      programs compared to standard practice, on survivor health and safety outcomes over a
      cumulative period of six months.

      Aim 2. Examine longitudinal changes in clinic-level screening, universal education, trauma
      informed counseling, safety action plans and referrals to on-site and/or partner IPV/SA
      programs and improved standards for documentation through the electronic health record (EHR)
      and continuous quality measurement and reporting.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: cluster randomized trial
primary purpose: Treatment
masking: Single (Participant)
measure: Change in use of safety behaviors
time frame: 6 months
description: Measured by percent of safety behaviors the woman has tried and found helpful on the Safety Behaviors Checklist. The checklist was adapted from Sullivan and colleagues and Parker and colleagues. Includes use of community resources and safety steps (e.g. asked for help, hidden emergency money) and use of formal services (e.g., women's shelter, protection order, mental health services).
measure: Change in Self-Efficacy to Use Harm Reduction Strategies
time frame: 6 months
description: Measure adapted from Tancredi et al and Hibbard et al, assesses confidence to seek help for abuse, if needed, from a health care provider.
measure: Provider Behavior
time frame: Baseline
description: Clinic level measure. Provider Behavior at Visit Survey items administered after the provider visit to assess the provider's adherence to universal education intervention, i.e. discussing healthy and unhealthy relationships during the visit, and referring to resources.
measure: Change in decisional conflict
time frame: 6 months
description: We have adapted questions from validated subscales of the Decisional Conflict Scale as a measure of decision process. Measures whether the intervention helps a woman to understand the advantages and disadvantages of safety planning options and to know her values related to them. The Decisional Conflict Scale discriminates between people who make decisions and those who delay making decisions.
measure: Change in Readiness to Take Action
time frame: 6 months
description: 0-10 scale of readiness to make changes to relationship for safety
arm group label: Universal Education
arm group type: Experimental
description: Train providers to integrate screening, universal education, trauma informed counseling, and mobile health (mHealth) technology through the myPlan app safety decision aid in collaboration with local IPV programs as well as the integration of documentation and quality improvement templates and measures into clinical settings.
arm group label: Standard Practice
arm group type: No Intervention
description: Standard clinical practice
intervention type: Behavioral
intervention name: Universal Education
description: Clinic provider/staff training on implementing universal education into clinical practice to: 1.) provide all women information about IPV/SA, harm reduction, and available safety resources; 2) provide trauma-informed counseling to women who disclose IPV/SA; includes access to the myPlan safety decision aid to develop a tailored safety action plan; 3) provide warm referrals in partnership with local domestic violence and sexual assault (DV/SA) advocacy agencies; 4) integrate documentation and quality improvement templates and measures into clinical settings.
arm group label: Universal Education
criteria: 
gender: Female
gender based: Yes
gender description: Cis-gender or trans-gender women.
minimum age: 18 Years
maximum age: 59 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nancy Glass, PhD, MPH, RN
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No