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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06263647
Other study ID # HSC-MS-23-0904
Secondary ID UG3NR021232
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2025
Est. completion date May 1, 2028

Study information

Verified date February 2024
Source The University of Texas Health Science Center, Houston
Contact Sandra McKay, MD
Phone (713) 500-5666
Email Sandra.McKay@uth.tmc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness of Houston-Hospital Violence Intervention Programs (HVIP) in reducing the occurrence of repeat violent events among adults receiving care at Memorial Hermann Hospital in Houston, to determine the impact of the community-engaged Houston-HVIP program on violent re-injury and mental and behavioral health, assess the impact of the Houston-HVIP program on racial and ethnic disparities in those impacted by firearm violence injury and to identify the predictors of implementation success, including dosage, reach, fidelity, and acceptability from the perspective of gun violence victims, health care providers, and community violence intervention specialists


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date May 1, 2028
Est. primary completion date February 1, 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria: - presented for a gunshot injury stemming from community violence at Memorial Hermann Hospital - English or Spanish-speaking - provide informed voluntary consent to participate in the study Exclusion Criteria: - presenting for a firearm injury arising from a self-inflicted gunshot, accidental firearm injury, unintentional gun violence, or domestic violence

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Houston-HVIP treatment
Participants will be assigned a case manager provide a brief assessment of psychological and social needs and individualized discharge planning bedside and will receive coordinated referral, networking, and close follow-up with community-level violence outreach organizations from the City of Houston Mayor's Office and the Health Equity Collective and will be referred for program enrollment to the Forgotten Third for credible messenger intervention and concurrent tailored intervention programs based on individual needs. Trauma counseling and referrals to tailored social service programs based on the patient's needs and follow-up contacts and services from an assigned case manager over 12 months following discharge from the hospital to ensure continuity of care and services. This will include ongoing case coordination and motivational interviewing to promote successful community-based program integration and completion will also be provided.
Enhanced Case Management
Participants will receive expanded case management services tailored to their personal needs and ongoing monitoring for three months for motivational interviewing, case coordination, social determinants of health referrals and referral for community-based resources. Based on each patient's needs, case managers will remain involved in the case past three months if needed.

Locations

Country Name City State
United States The University of Texas Health Science Center at Houston Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Repeat violent victimization as assessed by the number of participants who return to the hospital system for a violent injury monthly for 1 year
Primary Repeat violent victimization as assessed by the number of participants who are exposed to repeat violence but not admitted to the hospital captured using the Computer-assisted self-interviewing (CASI) instrument monthly for 1 year
Secondary Change in post-traumatic stress as assessed by the post-Traumatic Stress Disorder Checklist Version 5(PCL-5) This is a 20 item questionnaire and each is scored form 0(not at all)-4(extremely) for a maximum score of 80, higher score indicating worse outcome Baseline, monthly for 1 year
Secondary Change in aggression as assessed by the Buss-Perry Aggression Questionnaire (BPAQ) This is a 29 item questionnaire and and each is scored from 1-5 for a maximums core of 145 questions 7 and 18 are reverse scored. Higher score indicates more aggression. Baseline, monthly for 1 year
Secondary Change in general health as assessed by the 12-item Short Form Health Survey (SF-12) This is a 12 item questionnaire. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning Baseline, monthly for 1 year
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