Multidisciplinary Approach to Reduce Injury and Substance Abuse

NCT ID: NCT01048359

Last Updated: 2015-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

417 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2015-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Drug Abuse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Brief Intervention

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

Group Type EXPERIMENTAL

Brief Intervention

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Brief advice

Intervention Type 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

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.

Group Type EXPERIMENTAL

Brief Intervention plus Booster

Intervention Type 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

Interventions

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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.

Intervention Type 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

Intervention Type BEHAVIORAL

Brief Intervention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Texas at Austin

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mary M Velasquez, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Austin

Craig A Field, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas, El Paso

Locations

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University Medical Center Brackenridge

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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5R01DA026088-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DESPR DA026088

Identifier Type: -

Identifier Source: org_study_id