Multidisciplinary Approach to Reduce Injury and Substance Abuse

NCT01048359 | Completed Phase 3 DMC

• 2 other identifiers: DESPR DA0260885R01DA026088-02
• Study Type: interventional
• Target: 417
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Abuse

Keywords

Drug abuse, injury, trauma, screening, brief intervention.

Outcome Measures

Primary Outcomes (1)

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

  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.

  3, 6, and 12 months after intervention

Study Arms (3)

Brief Intervention

EXPERIMENTAL

30-45 minute motivational interviewing based intervention with feedback addressing drug use, injury prevention and HIV risk.

Behavioral: Brief Intervention

Brief advice

ACTIVE COMPARATOR

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

Brief Intervention plus Booster

EXPERIMENTAL

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

Interventions

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 advice

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 plus Booster

Brief Intervention BEHAVIORAL

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

Brief Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas at Austin: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University Medical Center Brackenridge

Austin, Texas, 78701, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Wounds and Injuries

Interventions

Crisis Intervention; Immunization, Secondary

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Officials

• Mary M Velasquez, PhD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

• Craig A Field, PhD

  University of Texas, El Paso

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2010
• First Posted: January 13, 2010
• Study Start: January 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: June 1, 2015
• Last Updated: November 25, 2015

Record last verified: 2015-11

Locations

US (1)