Realizing Opportunities for Self-Supported Improvement (ROSSI)

Depression Clinical Trial

— ROSE-SAFE  

Official title:

Healing Through Education, Advocacy and Law (HEAL) in Response to Violence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03016481
• Other study ID #: IHS-1507-31543
• Status: Completed
• Phase: N/A
• Start date: April 15, 2017
• Est. completion date: January 31, 2020

Study information

• Verified date: March 2020
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: January 31, 2020
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Subjects must be English speaking URMC patients, who are 18 years of age or older, and/or the non-offending parent on a CPS report for a URMC pediatrics patient, and who have experienced an IPV or emotional abuse event within the past 3 months.

IPV is defined as endorsing any of the following items:

1. Slapped, kicked, pushed, choked, or punched?

2. Forced or coerced to have sex?

3. Threatened you with a knife or gun to scare or hurt you?

4. Made you feel afraid that you would be physically hurt?

5. Repeatedly used words, yelled, or screamed in a way that frightened you?

6. Threatened you, put you down, or made you feel rejected? Yes No Additional inclusion criteria include depression based on PHQ-9 score of >10.

Exclusion Criteria:

• Subjects are ineligible if they have active psychosis or alcohol or substance dependence based on 3 months threshold on the Mini-International Neuropsychiatric Interview (MINI).

• Additionally, patients who are unable to understand the consent form or study procedures, are imminently suicidal, or are currently working with a CHW will be excluded.

Related Conditions & MeSH terms

• Depression
• Domestic Violence
• Quality of Life

Intervention

Behavioral:
• Active Comparator: the Community Health Worker -Personalized Support for Progress
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.
• Care as Usual- Social Worker
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.

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Safety	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.	immediate post intervention (6 months)
Primary	Depression	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.	9 months
Primary	Quality of Life	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.	12 months