An Outcome Evaluation of the Project CHANGE-MS Violence Intervention Program

NCT04567381 | Completed

• 1 other identifier: 2018-165
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective randomized control trial design to evaluate the effectiveness of a hospital based violence intervention program. Participants will be randomized into a "treatment as usual" group who will receive written referrals for services and an "enhanced services" group who will receive intensive case management over a one year period. Primary outcome will be rate of violent reinjury after enrollment. Follow-up will be for one year.

Conditions

Violence; Recidivism

Keywords

Violence prevention; Hospital based; Community Violence; Violent Recidivism

Outcome Measures

Primary Outcomes (2)

• Number of violent reinjuries in 12 months

  Subsequent violent reinjury

  12 months

• Number of participants with death in 12 months

  Death

  12 months

Secondary Outcomes (6)

• Decreased in Frequency of Substance Abuse in past-30 days

  12 months

• Improvement of Level of Mastery as measured using Pearlin Mastery Scale

  12 months

• Improvement in Disposition towards Violence as measured using the Code of the Street Scale

  12 months

• Decrease in number of Medical Legal Needs screened positive

  12 months

• Improved Life Satisfaction

  12 months

Study Arms (2)

Treatment as Usual

ACTIVE COMPARATOR

Treatment as Usual (TAU)/Control. Individuals randomized to TAU will receive a list of resources which provides participants with community agency information that they can engage on their own. The list of resources will include contact information for various services such as housing, employment, mental health and legal services. Patients randomized into this condition receive little to no assistance from program staff and must navigate the vast terrain of social service providers on their own.

Other: Treatment as Usual

Enhanced Services

EXPERIMENTAL

Enhanced Services/Treatment (ES). Participants randomized to the ES intervention will receive intensive community-based case management.

Other: Enhanced Services

Interventions

Enhanced Services OTHER

In enhanced services, the provision of services go beyond just referring a patient and leaving them to follow-through on their own accord. ES varies based on resources, model of service delivery, philosophy, and role and responsibilities of team members. Enhanced services usually includes longer-term case management which can then facilitate the connection to clinical counseling, victim assistance, familial assistance, legal assistance, emergency financial funding, transportation for subsequent appointments related to a patient's medical condition, employment assistance, and assistance in educational program enrollment.

Enhanced Services

Treatment as Usual OTHER

Individuals randomized to TAU will receive a list of resources which provides participants with community agency information that they can engage on their own. The list of resources will include contact information for various services such as housing, employment, mental health and legal services. Patients randomized into this condition receive little to no assistance from program staff and must navigate the vast terrain of social service providers on their own.

Treatment as Usual

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Self-identified men
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• identify as male
• be 18 years of age or older
• speak English
• have experienced a violent injury in the form of a gunshot wound, stabbing, or assault within two years of first contact with the program (verified through trauma registry)
• experienced the injury within the borders of the east coast city where the study is taking place.

You may not qualify if:

• identifying as female
• reporting an age ≤ 17
• experiencing a self-inflicted violent injury
• experiencing a traumatic brain injury
• being under police custody
• not being injured within the borders of the east coast city where the study is taking place
• not being able to provide informed consent

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (1)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Recidivism

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Criminal Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized into two separate groups, treatment as usual and enhanced services. Groups will be followed concurrently for one year for the outcomes of interest.

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: September 28, 2020
• Study Start: August 1, 2018
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2021
• Last Updated: February 14, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)