Clinical trial NCT03259646: The IPV Provider Network: Engaging the Health Care Provider Response to Interpersonal Violence Against Women
Official title: The IPV Provider Network: Engaging the Health Care Provider Response to Interpersonal Violence Against Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Violence, Domestic
Violence, Sexual
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Office of Research on Women's Health (ORWH)
name: University of Pittsburgh
name: Futures Without Violence
First posted: 2017-08-24
Enrollment: 6272
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: cluster randomized trial
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in use of safety behaviors
timeFrame: 6 months
measure: Change in Self-Efficacy to Use Harm Reduction Strategies
timeFrame: 6 months
measure: Provider Behavior
timeFrame: Baseline
Secondary outcomes:
measure: Change in decisional conflict
timeFrame: 6 months
measure: Change in Readiness to Take Action
timeFrame: 6 months
Other outcomes:
Locations:
city: Kingman
country: United States
facility: North County HealthCare
state: Arizona
city: Lake Havasu City
country: United States
facility: North Country HealthCare
state: Arizona
city: Williams
country: United States
facility: North Country HealthCare
state: Arizona
city: Boston
country: United States
facility: Partners Health Care Brigham and Women's Hospital
state: Massachusetts
city: Pittsburgh
country: United States
facility: Magee-Women's Hospital of UPMC
state: Pennsylvania
city: Charleston
country: United States
facility: Women's Health Center
state: West Virginia
city: Mill Creek
country: United States
facility: Valley Health
state: West Virginia
city: Ronceverte
country: United States
facility: Greenbrier Co. Health Dept
state: West Virginia
city: Scott Depot
country: United States
facility: FamilyCare Health Center
state: West Virginia
Study officials:
affiliation: Johns Hopkins University
name: Nancy Glass, PhD, MPH, RN
role: PRINCIPAL_INVESTIGATOR
References: