Multidisciplinary Approach to Reduce Injury and Substance Abuse

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Texas at Austin
ClinicalTrials.gov Identifier:
NCT01048359
First received: January 11, 2010
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Drug Abuse
Behavioral: Brief advice
Behavioral: Brief Intervention plus Booster
Behavioral: Brief Intervention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Multidisciplinary Approach to Reduce Injury and Substance Abuse

Resource links provided by NLM:


Further study details as provided by University of Texas at Austin:

Primary Outcome Measures:
  • The primary outcome of interest will be patients' subsequent drug use. [ Time Frame: 3, 6, and 12 months after intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 930
Study Start Date: January 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brief Intervention
30-45 minute motivational interviewing based intervention with feedback addressing drug use, injury prevention and HIV risk.
Behavioral: Brief Intervention
A brief drug use intervention based on motivational interviewing is provided to participants at baseline
Active Comparator: Brief advice
This condition of the experiment acts a control and will be a short session in which the therapist will provide brief advice about drug use and give the patient a pamphlet.
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.
Experimental: Brief Intervention plus Booster
30-45 minute motivational interviewing based intervention with feedback addressing drug use, injury prevention and HIV risk plus a brief phone booster session at 1 month post-intake to review feedback, 2) assess progress, 2) renew motivation to change, and 3) evaluate and affirm commitment to change.
Behavioral: 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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01048359

Locations
United States, Texas
University Medical Center Brackenridge
Austin, Texas, United States, 78701
Sponsors and Collaborators
University of Texas at Austin
Investigators
Principal Investigator: Mary M Velasquez, PhD University of Texas at Austin
Principal Investigator: Craig A Field, PhD University of Texas at Austin
  More Information

No publications provided

Responsible Party: University of Texas at Austin
ClinicalTrials.gov Identifier: NCT01048359     History of Changes
Other Study ID Numbers: DESPR DA026088, 5R01DA026088-02
Study First Received: January 11, 2010
Last Updated: July 9, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Texas at Austin:
Drug abuse, injury, trauma, screening, brief intervention.

Additional relevant MeSH terms:
Substance-Related Disorders
Wounds and Injuries
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 21, 2014