F.Y.I.: Flint Youth Injury Study

Drug Usage Clinical Trial

— FYI  

Official title:

Substance Use Among Violently Injured Youth in Urban ER: Services & Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01152970
• Other study ID #: DA024646 01A2
• Secondary ID: R01DA024646-01A2
• Status: Completed
• Phase: N/A
• First received: June 28, 2010
• Last updated: August 8, 2016
• Start date: November 2009
• Est. completion date: December 2013

Study information

• Verified date: August 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The provision of medical services in an inner city Emergency Department (ED) provides a critical opportunity to identify and characterize future timing and pattern of service use among youth with drug use, who may be missed in school-based samples, and who may not yet be in the criminal justice system. Currently, there is a paucity of data on the timing, pattern, barriers, and trajectory of youth with multiple risks (illicit drug use and ED visit for acute violence related injury) in terms of their intersection with health services (substance use treatment, mental health, medical) and criminal justice system, which limits the development of optimal timing and setting for interventions. Youth treated in the ED may have exacerbated rates of illicit drug use, and other risk behaviors (i.e. delinquency, HIV risk behaviors, weapon carriage) and different trajectories of outcomes and interactions with service use sectors based on presentation for intentional injury as compared to other complaints (medical, unintentional injuries). Understanding the outcomes and service utilization among inner-city youth with drug use with and without acute violent injury is critically important in developing prevention and treatment services to address these multiple risk factors. The investigators propose a prospective observational study over a two-year period to identify a high risk group of youth with past year illicit drug use (N=650) seeking care in an inner city ED. The specific aims of the study, chosen to obtain data necessary to determine the location and content of subsequent interventions, are: (1) To describe characteristics of youth (ages 14-24; n=650) who report illicit drug use presenting to an urban ED for an acute violent injury (n=350), compared to youth with drug use who seek non-violence related ED care (n=300), including demographic characteristics, problem severity (e.g., substance use, violence, HIV risk behaviors, etc.), enabling factors, and service utilization (i.e., substance use treatment, mental health, and medical); (2) To identify the trajectories of participants' interactions with health services during the two years following their ED visit and the key characteristics (i.e., predisposing, enabling, and need factors) associated with types of service use (substance abuse treatment, mental health, and medical/ ED) and barriers to these services; and, (3) To measure two-year outcomes for this cohort and to identify key demographic and clinical characteristics of youth with drug use, who have poor outcomes in the two years after ED visit for intentional injury and other medical care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 638
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 14 Years to 24 Years

Eligibility

Inclusion Criteria:

Inclusion criteria for screening:

1. youth (ages 14-24) presenting to the Hurley Medical Center (HMC) ED who are medically stable. Patients classified by medical staff as having unstable vital signs or "Level 1" trauma (e.g., unconscious, in need of immediate lifesaving procedures such as surgery), will be approached during their inpatient stay after stabilization (4% based on prior work);

2. access to a parent or guardian for consent among adolescents ages 14-17 (over 90% based on our prior work).

Positive substance use screen criteria: Youth will be eligible for the longitudinal study if they endorse on self-report computer survey past year use of illicit drugs (e.g. marijuana, cocaine, inhalants, non-prescribed use of psychoactive prescription drugs, etc).-

Exclusion Criteria:

1. youth who do not understand English

2. youth deemed unable to provide informed assent/consent by ED or research staff

3. prisoners at time of ED presentation.

4. youth who present to the ED as victims of sexual abuse or child abuse -

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Drug Usage

Locations

Country	Name	City	State
United States	Hurley Medical Center Emergency Department	Flint	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	substance use as assessed with both the Mini-International Neuropsychiatric Interview		Change from baseline substance use at 24 month	No
Primary	substance use as assessed with the National Institute on Drug Abuse- Modified Alcohol, Smoking and Substance Involvement Screening Test		Change from baseline substance use at 24 month	No
Primary	violence behaviors as assessed with the modified Conflict Tactic Scale		Change from baseline violence behaviors at 24 month	No
Primary	HIV risk behaviors as assessed with the Risk Assessment Battery		Change from baseline HIV risk behaviors at 24 month	No
Primary	trajectories of participants' interactions with health services during the two years following their ED visit for an acute violent injury or for non-violence related care	Services will include substance abuse treatment, mental health services, and medical services including ED recidivism and HIV testing as assessed through chart review	through the study completion, over 24 months	No