| Registry | NCT03259646 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 6272 (Actual) |
| Sponsor | Johns Hopkins University (Other); collaborators: Office of Research on Women's Health (ORWH), University of Pittsburgh, Futures Without Violence |
| Conditions | Violence, Domestic, Violence, Sexual |
| Interventions | Universal Education (Behavioral) |
| Dates | start 2017-05-26, primary completion 2019-04-25, completion 2019-04-25, first posted 2017-08-24, last updated 2020-01-18 |
| Locations | 9 sites in United States |
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All trials for Violence, Domestic All trials for Violence, Sexual All trials of Universal Education
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Universal Education | Experimental | Behavioral: 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. |
| Standard Practice | No intervention | Standard clinical practice |
Sex: Female, ages: 18 Years to 59 Years, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| North County HealthCare | Kingman, Arizona | United States | |
| North Country HealthCare | Lake Havasu City, Arizona | United States | |
| North Country HealthCare | Williams, Arizona | United States | |
| Partners Health Care Brigham and Women's Hospital | Boston, Massachusetts | United States | |
| Magee-Women's Hospital of UPMC | Pittsburgh, Pennsylvania | United States | |
| Women's Health Center | Charleston, West Virginia | United States | |
| Valley Health | Mill Creek, West Virginia | United States | |
| Greenbrier Co. Health Dept | Ronceverte, West Virginia | United States | |
| FamilyCare Health Center | Scott Depot, West Virginia | United States |