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Completed

NCT Number: NCT01048359

Multidisciplinary Approach to Reduce Injury and Substance Abuse

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.

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Key information

Conditions

Drug Abuse Chemically-Induced Disorders Mental Disorders Substance-Related Disorders Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Medical Center Brackenridge

Austin, Texas, 78701, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief Advice

Behavioral

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

Behavioral

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

Behavioral

A brief drug use intervention based on motivational interviewing is provided to participants at baseline

Primary outcomes

  1. The primary outcome of interest will be patients' subsequent drug use.

    Time frame: 3, 6, and 12 months after intervention

Secondary outcomes

  1. 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.

    Time frame: 3, 6, and 12 months after intervention

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
Jan 13, 2010
Registry last updated
Nov 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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