The Teachable Moment: Screening and Brief Intervention for Admitted Trauma Patients (TM)

August 7, 2018 updated by: Wake Forest University Health Sciences
The American College of Surgeons now requires screening for alcohol use in trauma centers. The purpose of this research study is to provide information about the best screening and treatment methods. The investigators hope the findings will provide information that will improve healthcare by reducing problems related to risky alcohol use. The trauma team is conducting a comparison of two different ways of talking about alcohol use. Participants will be randomized into one of the two study groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The goal of this study is to guide further policy development regarding effective alcohol screening by: (a) comparing the effectiveness of two new, shorter screening tools for risky drinking patterns with the longer screening tool in current use; (b) assessing the outcomes of two different brief counseling interventions (BIs) with trauma patients screened to have risky drinking behaviors; and (c) examining the impact of the implementation of this new policy in a Level I Trauma Center.

The Specific Aims will be accomplished by:

  1. Screening patients who are admitted to the Trauma Center, and conducting BIs for all who screen positive;
  2. Collecting formative qualitative data regarding participants' perceptions of benefits of drunken states, their individual risks, and perceived healthier alternatives;
  3. Collecting quantitative data (injury severity score and hospital length of stay) and correlating these data with patient demographics and responses on the different screening methods;
  4. Collecting follow-up data by telephone on self-reported alcohol use and trauma recidivism, using an interviewer-administered assessment;
  5. Collecting data on trauma recidivism from ED data, publicly available records, and patient self-report at 6-month telephone follow-up;
  6. Surveying trauma staff and physicians at three intervals regarding the process of implementing the new ACS policy, any perceived difficulties, and the perceived impact

Study Type

Interventional

Enrollment (Actual)

333

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Baptist Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Inpatient on trauma service
  • 18 years or older
  • Speaks either English or Spanish

One or more of the following:

  • Patient answered yes to either admission screening question
  • Patient has a positive BAL of less than or equal to 79 and also has a positive Audit score (men greater than or equal to 8; women greater than or equal to 4)
  • Patient has a BAL of 80 or higher
  • patient has no record of a BAL on file and they have a positive Audit score

Exclusion Criteria:

  • Patient unable or unwilling to provide informed consent
  • Patient refusal contact at six months
  • Patient has a positive BAL of less than or equal to 79 and negative AUDIT score
  • Patient deemed unable to complete a BI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Arm number 1 focuses on the traditional quantity frequency model.
Behavioral: Quantity Frequency Model
The quantitative intervention involves emphasis on tracking and measuring the number of drinks on a weekly basis.
Experimental: 2
Arm number 2 targets subjective drunkenness.
Behavioral: Targets Subjective Drunkenness
Explores factors leading to drunkenness and alternative coping strategies for healthier function.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Trauma recidivism after discharge as measured by a review of computerized ED records,NC Trauma database,the Forsyth County EMS registry,NC EMS registry and self-reports at a 6-month telephone follow-up of alcohol-related injuries and changes in alcohol
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient satisfaction ratings of the BI,the response to the BI as rated by the interviewer,reported citations for driving under the influence(to be obtained from the NC State Department of Motor Vehicles) and 3 surveys of trauma service staff
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

Robert Wood Johnson Foundation

Investigators

  • Principal Investigator: Mary Claire O'Brien, MD, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

March 17, 2009

First Submitted That Met QC Criteria

March 18, 2009

First Posted (Estimate)

March 19, 2009

Study Record Updates

Last Update Posted (Actual)

August 9, 2018

Last Update Submitted That Met QC Criteria

August 7, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00006734

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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