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The IPV Provider Network: Engaging the Health Care Provider Response to Interpersonal Violence Against Women

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ClinicalTrials.gov Identifier: NCT03259646
Recruitment Status : Active, not recruiting
First Posted : August 24, 2017
Last Update Posted : January 15, 2019
Sponsor:
Collaborators:
Office of Research on Women's Health (ORWH)
University of Pittsburgh
Futures Without Violence
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Violence, Domestic Violence, Sexual Behavioral: Universal Education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: cluster randomized trial
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The IPV Provider Network: Engaging the Health Care Provider Response to Interpersonal Violence Against Women
Actual Study Start Date : May 26, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Arm Intervention/treatment
Experimental: Universal Education
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.
Behavioral: Universal Education
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.

No Intervention: Standard Practice
Standard clinical practice



Primary Outcome Measures :
  1. Change in use of safety behaviors [ Time Frame: 6 months ]
    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).

  2. Change in Self-Efficacy to Use Harm Reduction Strategies [ Time Frame: 6 months ]
    Measure adapted from Tancredi et al and Hibbard et al, assesses confidence to seek help for abuse, if needed, from a health care provider.

  3. Provider Behavior [ Time Frame: Baseline ]
    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.


Secondary Outcome Measures :
  1. Change in decisional conflict [ Time Frame: 6 months ]
    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.

  2. Change in Readiness to Take Action [ Time Frame: 6 months ]
    0-10 scale of readiness to make changes to relationship for safety



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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Cis-gender or trans-gender women.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Seeking healthcare at one of 14 partner clinics
  • Ability to complete a survey on a device (computer/tablet/smartphone in English or Spanish)
  • Access to safe device (as defined above) if doing surveys online
  • Has a safe email address or safe phone number
  • Is not acutely ill

Exclusion Criteria:

  • Male
  • Not seeking healthcare at one of 9 partner clinics
  • Younger than 18 years of age
  • Older than 59 years of age
  • Cannot read/speak English or Spanish
  • No access to safe device if doing surveys online
  • Does not have a safe email address or safe phone number
  • Acutely ill

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03259646


Locations
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United States, Arizona
North County HealthCare
Kingman, Arizona, United States, 86401
North Country HealthCare
Lake Havasu City, Arizona, United States, 86403
North Country HealthCare
Williams, Arizona, United States, 86046
United States, Massachusetts
Partners Health Care Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Pennsylvania
Magee-Women's Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
United States, West Virginia
Women's Health Center
Charleston, West Virginia, United States, 25302
Valley Health
Mill Creek, West Virginia, United States, 26280
Greenbrier Co. Health Dept
Ronceverte, West Virginia, United States, 24970
FamilyCare Health Center
Scott Depot, West Virginia, United States, 25560
Sponsors and Collaborators
Johns Hopkins University
Office of Research on Women's Health (ORWH)
University of Pittsburgh
Futures Without Violence
Investigators
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Principal Investigator: Nancy Glass, PhD, MPH, RN Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03259646     History of Changes
Other Study ID Numbers: IRB00090497
6 ASTWH150032-01 ( Other Grant/Funding Number: Office of Women's Health )
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No