Multidisciplinary Approach to Reduce Injury and Substance Abuse
|ClinicalTrials.gov Identifier: NCT01048359|
Recruitment Status : Completed
First Posted : January 13, 2010
Last Update Posted : November 25, 2015
|Condition or disease||Intervention/treatment||Phase|
|Drug Abuse||Behavioral: Brief advice Behavioral: Brief Intervention plus Booster Behavioral: Brief Intervention||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||417 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Multidisciplinary Approach to Reduce Injury and Substance Abuse|
|Study Start Date :||January 2010|
|Primary Completion Date :||April 2014|
|Study Completion Date :||June 2015|
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
- The primary outcome of interest will be patients' subsequent drug use. [ Time Frame: 3, 6, and 12 months after intervention ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01048359
|United States, Texas|
|University Medical Center Brackenridge|
|Austin, Texas, United States, 78701|
|Principal Investigator:||Mary M Velasquez, PhD||University of Texas at Austin|
|Principal Investigator:||Craig A Field, PhD||University of Texas, El Paso|