Domestic ViolenceROSE-SAFENCT03016481
Realizing Opportunities for Self-Supported Improvement (ROSSI)
A study testing Active Comparator: the Community Health Worker -Personalized Support for Progress and Care as Usual- Social Worker in people with Domestic Violence and Depression, run by University of Rochester at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Domestic Violence, Depression, Quality of Life
- What is being tested?
- Active Comparator: the Community Health Worker -Personalized Support for Progress and Care as Usual- Social Worker
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 231 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2017to 31 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Healing Through Education, Advocacy and Law (HEAL) in Response to Violence
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.
- Conditions
- Domestic Violence, Depression, Quality of Life
- Being tested
- Active Comparator: the Community Health Worker -Personalized Support for Progress, Care as Usual- Social Worker
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Comparator: the Community Health Worker -Personalized Support for ProgressBehavioural
Also called CHW-PSP
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 WorkerBehavioural
Also called CAU-SW
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.
| Study group | Role | What they receive |
|---|---|---|
| the Community Health Worker -Personalized Support for Progress | Active comparator | 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. Receives: Behavioral: Active Comparator: the Community Health Worker -Personalized Support for Progress |
| Care as Usual- Social Worker | Active comparator | 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. Receives: Behavioral: Care as Usual- Social Worker |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: immediate post intervention (6 months)
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.
Measured: 9 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study start15 Apr 2017
- Primary completion30 Nov 2019
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Domestic ViolenceStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine Cerulli, University of Rochester
- Investigators
- Catherine Cerulli, JD, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03016481
- Sponsor's protocol ID
- IHS-1507-31543
- Acronym
- ROSE-SAFE
- Status last verified
- Mar 2020
- First submitted
- 6 Jan 2017
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing Through Education, Advocacy and Law (HEAL) in Response to Violence
- ClinicalTrials.gov ID
- NCT03016481
- Acronym / sponsor ID
- ROSE-SAFE / IHS-1507-31543
- Conditions
- Domestic Violence, Depression, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 15 Apr 2017 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 10 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the Community Health Worker -Personalized Support for Progress | Active comparator | Behavioral: Active Comparator: the Community Health Worker -Personalized Support for ProgressPatients 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. |
| Care as Usual- Social Worker | Active comparator | Behavioral: Care as Usual- Social WorkerPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- 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?
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Comparator: the Community Health Worker -Personalized Support for ProgressAlso: CHW-PSPSubjects 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. | Behavioural | the Community Health Worker -Personalized Support for Progress |
| Care as Usual- Social WorkerAlso: CAU-SWBased 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. | Behavioural | Care as Usual- Social Worker |
Primary outcome
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-9 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Cerulli, JD, PhD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Comparator: the Community Health Worker -Personalized Support for Progress and Care as Usual- Social Worker in people with Domestic Violence and Depression, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Safety (time frame: immediate post intervention (6 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2020.