Skin Injury Due to ViolenceTSINCT02642224
Trauma Services Intervention to Prevent Violence
A study testing Social Work Case Management in people with Skin Injury Due to Violence and Gunshot Wound, Contact, run by University of Pittsburgh at 1 site in United States.
Trial summary
Primary outcome: Research participants and their network contacts will be followed over 6 months to assess whether a social work case management protocol results in reduction of trauma services recidivism and criminal violence arrests. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Skin Injury Due to Violence, Gunshot Wound, Contact
- What is being tested?
- Social Work Case Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to May 2018
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18+
- Gunshot victim treated and discharged from Level I trauma facility; or member of social network of gunshot victim who may be high risk of firearm violence -
Who cannot join
- Gunshot wound because of suicide attempt
- Gunshot wound because of non-violent episode (e.g., hunting accident)
- Unable to participate in research interview because of cognitive deficit
- Planning to leave community as result of shooting
- Discharged from trauma service to prison
- Unable to provide informed consent -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh, Graduate School of Public Health
Pittsburgh, Pennsylvania, 15261
About this study
Primary outcome: Research participants and their network contacts will be followed over 6 months to assess whether a social work case management protocol results in reduction of trauma services recidivism and criminal violence arrests.
Read the detailed description
Allegheny County, PA continues to suffer between 100-120 homicides each year, with perhaps 2-3 times as many gunshot injuries that require hospitalization. Firearm homicides overwhelmingly affect African American men aged 15-35. Building on prior efforts in violence prevention, the investigators propose to launch a hospital trauma service intervention that will take advantage of a "teachable moment" in the emergency room. All four hospitals providing Level I Trauma services in Allegheny County have agreed to host the program, an evidence-based effort developed by the National Network of Hospital Violence Intervention (NNHVI). Adaptation of the NNHVI model will focus on the social networks of gunshot victims as well as the victims themselves. Intervention efforts will range from job training and mentoring to relocation to different communities. The investigators will offer the opportunity to participate in the research and receive the intervention to all gunshot victims identified in county Level I trauma services. Participants in the research protocol will be asked to recruit their high-risk social network members for the intervention.
- Being tested
- Social Work Case Management
- Keywords
- Violence, firearm, guns, homicide, trauma, injury
- Medical subject headings
- Wounds, Gunshot, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Work Case ManagementBehavioural
The National Network of Hospital Violence Intervention (NNHVI) suggests that intervening when gunshot victims are receiving treatment in hospital trauma services may be effective in linking high-risk individuals to appropriate case management services, and that this service linkage may lower the risk of further violence. Our adaptation of the NNHVI model will focus on the social networks of gunshot victims as well as the victims themselves. Intervention efforts will range from job training and mentoring to relocation to different communities.
| Study group | Role | What they receive |
|---|---|---|
| Social work intervention | Experimental | The National Network of Hospital Violence Intervention (NNHVI) suggests that intervening when gunshot victims are receiving treatment in hospital trauma services may be effective in linking high-risk individuals to appropriate case management services, and that this service linkage may lower the risk of further violence. Our adaptation of the NNHVI model will focus on the social networks of gunshot victims as well as the victims themselves. Intervention efforts will range from job training and mentoring to relocation to different communities. Receives: Behavioral: Social Work Case Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trauma services recidivism
Readmission to hospital trauma service because of firearm injury
Measured: 6 months
Arrest for violent crime
Arrests involving criminal violence noted in DA docket
Measured: 6 months
Secondary outcomes (1)
Social work case management goals
Educational program enrollment, job training, receipt of drug and alcohol treatment, trauma counseling
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2015 (estimated)
- Study startMay 2014
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Injury Due to ViolenceStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- The Pittsburgh Foundation, Hillman Foundation, RK Mellon Foundation
- Responsible party
- Principal investigator, Steven M. Albert, University of Pittsburgh
- Investigators
- Steven M Albert, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02642224
- Sponsor's protocol ID
- UN2013-67786
- Acronym
- TSI
- Status last verified
- Jun 2018
- First submitted
- 27 Dec 2013
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data will be archived and made available to qualified investigators
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trauma Services Intervention to Prevent Violence
- ClinicalTrials.gov ID
- NCT02642224
- Acronym / sponsor ID
- TSI / UN2013-67786
- Keywords
- Violence, firearm, guns, homicide, trauma, injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- The Pittsburgh Foundation, Hillman Foundation, RK Mellon Foundation
- Study start
- May 2014
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 30 Dec 2015 (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.
Primary outcome: Research participants and their network contacts will be followed over 6 months to assess whether a social work case management protocol results in reduction of trauma services recidivism and criminal violence arrests.
Detailed description
Allegheny County, PA continues to suffer between 100-120 homicides each year, with perhaps 2-3 times as many gunshot injuries that require hospitalization. Firearm homicides overwhelmingly affect African American men aged 15-35. Building on prior efforts in violence prevention, the investigators propose to launch a hospital trauma service intervention that will take advantage of a "teachable moment" in the emergency room. All four hospitals providing Level I Trauma services in Allegheny County have agreed to host the program, an evidence-based effort developed by the National Network of Hospital Violence Intervention (NNHVI). Adaptation of the NNHVI model will focus on the social networks of gunshot victims as well as the victims themselves. Intervention efforts will range from job training and mentoring to relocation to different communities. The investigators will offer the opportunity to participate in the research and receive the intervention to all gunshot victims identified in county Level I trauma services. Participants in the research protocol will be asked to recruit their high-risk social network members for the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Social work intervention | Experimental | Behavioral: Social Work Case ManagementThe National Network of Hospital Violence Intervention (NNHVI) suggests that intervening when gunshot victims are receiving treatment in hospital trauma services may be effective in linking high-risk individuals to appropriate case management services, and that this service linkage may lower the risk of further violence. Our adaptation of the NNHVI model will focus on the social networks of gunshot victims as well as the victims themselves. Intervention efforts will range from job training and mentoring to relocation to different communities. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18+
- Gunshot victim treated and discharged from Level I trauma facility; or member of social network of gunshot victim who may be high risk of firearm violence -
Key exclusion criteria (6 listed)
- Gunshot wound because of suicide attempt
- Gunshot wound because of non-violent episode (e.g., hunting accident)
- Unable to participate in research interview because of cognitive deficit
- Planning to leave community as result of shooting
- Discharged from trauma service to prison
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 |
|---|---|---|
| Social Work Case ManagementThe National Network of Hospital Violence Intervention (NNHVI) suggests that intervening when gunshot victims are receiving treatment in hospital trauma services may be effective in linking high-risk individuals to appropriate case management services, and that this service linkage may lower the risk of further violence. Our adaptation of the NNHVI model will focus on the social networks of gunshot victims as well as the victims themselves. Intervention efforts will range from job training and mentoring to relocation to different communities. | Behavioural | Social work intervention |
Primary outcome
Trauma services recidivism
Time frame: 6 months
Readmission to hospital trauma service because of firearm injury
Arrest for violent crime
Time frame: 6 months
Arrests involving criminal violence noted in DA docket
1 secondary outcome
Social work case management goals
Time frame: 6 months
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 2 Jul 2018.
- Individual participant dataSharing planned: Yes. Data will be archived and made available to qualified investigators
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.
Steven M Albert, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Work Case Management in people with Skin Injury Due to Violence and Gunshot Wound, Contact, run by University of Pittsburgh 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 2 inclusion and 6 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 2 Jul 2018. 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?
Trauma services recidivism (time frame: 6 months). The study lists 2 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 2 Jul 2018.