Multidisciplinary Approach to Reduce Injury and Substance Abuse

Drug Abuse Clinical Trial

Official title:

Multidisciplinary Approach to Reduce Injury and Substance Abuse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01048359
• Other study ID #: DESPR DA026088
• Secondary ID: 5R01DA026088-02
• Status: Completed
• Phase: Phase 3
• First received: January 11, 2010
• Last updated: November 23, 2015
• Start date: January 2010
• Est. completion date: June 2015

Study information

• Verified date: November 2015
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 417
• Est. completion date: June 2015
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Drug Abuse

Intervention

Behavioral:
• Brief advice
The American College of Surgeons (ACS) recently mandated standards of care for all level I trauma centers and currently defined standards of care at the collaborating institution requires that assessment and referral are included in treatment as usual. Therefore, our treatment as usual, or BA, consists of an initial interview conducted by study staff, a recommendation to abstain from drug use, provision of educational material supporting that recommendation, referral to hospital or community treatment resources most likely to be beneficial to the patient and information about relevant community health care agencies.
• Brief Intervention plus Booster
A brief drug use intervention based on motivational interviewing is provided to participants at baseline and a booster session incorporating personalized feedback is provided at one month
• Brief Intervention
A brief drug use intervention based on motivational interviewing is provided to participants at baseline

Locations

Country	Name	City	State
United States	University Medical Center Brackenridge	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas at Austin	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome of interest will be patients' subsequent drug use.		3, 6, and 12 months after intervention	No
Secondary	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.		3, 6, and 12 months after intervention	No