Clinical trial NCT01048359: Multidisciplinary Approach to Reduce Injury and Substance Abuse
Official title: Multidisciplinary Approach to Reduce Injury and Substance Abuse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Drug Abuse
Keywords: Drug abuse, injury, trauma, screening, brief intervention.
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2010-01-13
Enrollment: 417
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary purpose of the project entitled: Multidisciplinary Approach to Reduce Injury and Substance Abuse, which is funded by the National Institute on Drug Abuse (5R01DA026088-02), is to compare the effectiveness of brief intervention, brief intervention plus a booster, and brief advice for adult patients who abuse drugs and present to a trauma department for treatment of an injury.

Detailed description: Multidisciplinary Approach to Reduce Injury and Substance Abuse is a randomized clinical trial evaluating the effectiveness of brief advice (BA), brief motivational intervention with feedback (BMI), and brief motivational intervention with feedback and booster (BMI+B) in injured patients with drug problems.

The setting is a level 1 Trauma Department, which serves a large and diverse patient population. Injured patients are screened for eligibility in the project based on a positive toxicology screen or self reported drug use in the past 90 days. The primary outcome of interest will be patients' subsequent drug use. Other outcomes of interest include: HIV-related risk behaviors, improved health outcomes (including injury reduction), increased employment, decreased engagement in illegal behavior, increased substance abuse treatment utilization, and enhanced quality of life at three, six, and twelve month follow-ups.

This study will also examine the potential moderating and mediating effects of patient readiness to change, use of experiential and behavioral processes of change and decisional balance considerations. In addition, this project will examine implementation factors at the organizational level and the cost effectiveness of BA, BMI, and BMI+B.

Study participants and their related identifying information will be collected during the time they are admitted to the recruitment hospital trauma department. Study participants must be 18 years or older, speak English or Spanish, have been admitted to the recruitment hospital trauma department, and test positive for illegal drugs or admit to illegal drug use when verbally screened. Additional information will be collected from participants in the in-person assessment interviews at three, six, and 12 month follow-up periods.

Eligibility criteria: Inclusion Criteria:

* Study participants must be 18 years or older
* Speak English or Spanish
* Been admitted to the level 1 Trauma Department
* Test positive for illegal drugs or admit to illegal drug use

Exclusion Criteria:

* Other penetrating trauma not related to motor vehicle collisions, violence or falls, such as poisoning and, bites
* Patients with traumatic brain injury, or a Glasgow Coma Scale score of less than 15
* Patients who do not pass the Mini-Mental Status Exam are excluded

Primary outcomes:
measure: The primary outcome of interest will be patients' subsequent drug use.
timeFrame: 3, 6, and 12 months after intervention
Secondary outcomes:
measure: HIV risk-behaviors, improved health, increased employment, decreased illegal behavior, increased substance treatment, enhanced quality of life, use of Transtheoretical model of change, organization implementation, and intervention cost-effectiveness.
timeFrame: 3, 6, and 12 months after intervention
Other outcomes:
Locations:
city: Austin
country: United States
facility: University Medical Center Brackenridge
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Mary M Velasquez, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas, El Paso
name: Craig A Field, PhD
role: PRINCIPAL_INVESTIGATOR
References: