Realizing Opportunities for Self-Supported Improvement (ROSSI) (ROSE-SAFE)
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ClinicalTrials.gov Identifier: NCT03016481 |
Recruitment Status
:
Recruiting
First Posted
: January 10, 2017
Last Update Posted
: January 11, 2018
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Condition or disease | Intervention/treatment | Phase |
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Domestic Violence Depression Quality of Life | Behavioral: Active Comparator: the Community Health Worker -Personalized Support for Progress Behavioral: Care as Usual- Social Worker | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 300 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Supportive Care |
Official Title: | Healing Through Education, Advocacy and Law (HEAL) in Response to Violence |
Actual Study Start Date : | April 15, 2017 |
Estimated Primary Completion Date : | September 2018 |
Estimated Study Completion Date : | November 2019 |

Arm | Intervention/treatment |
---|---|
Active Comparator: the Community Health Worker -Personalized Support for Progress
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.
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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.
Other Name: CHW-PSP
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Active Comparator: Care as Usual- Social Worker
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.
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Behavioral: 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.
Other Name: CAU-SW
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- Patient Safety [ Time Frame: immediate post intervention (6 months) ]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.
- Depression [ Time Frame: 9 months ]To assess whether CHW-PSP leads to improved depression and health function post-intervention (9 months). The PHQ-930 is a screen for major depressive disorder with good discriminant validity and sensitivity to change that has been validated in variety of settings.
- Quality of Life [ Time Frame: 12 months ]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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:
- Slapped, kicked, pushed, choked, or punched?
- Forced or coerced to have sex?
- Threatened you with a knife or gun to scare or hurt you?
- Made you feel afraid that you would be physically hurt?
- Repeatedly used words, yelled, or screamed in a way that frightened you?
- 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.

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): NCT03016481
Contact: Iwona Juskiewicz, MD, MPH | 585-275-4961 | iwona_juskiewicz@urmc.rochester.edu |
United States, New York | |
University of Rochester | Recruiting |
Rochester, New York, United States, 14620 | |
Contact: Iwona USA Juskiewicz, MD, MPH 585-275-4961 iwona_juskiewicz@urmc.rochester.edu | |
Principal Investigator: Catherine Cerulli, PhD |
Principal Investigator: | Catherine Cerulli, JD, PhD | University of Rochester |
Responsible Party: | Catherine Cerulli, Director of Susan B. Anthony Center for Women's Leadership and the Laboratory of Interpersonal Violence and Victimization, University of Rochester |
ClinicalTrials.gov Identifier: | NCT03016481 History of Changes |
Other Study ID Numbers: |
IHS-1507-31543 |
First Posted: | January 10, 2017 Key Record Dates |
Last Update Posted: | January 11, 2018 |
Last Verified: | January 2018 |
Studies a U.S. FDA-regulated Drug Product: | No | |
Studies a U.S. FDA-regulated Device Product: | No |