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

This study has been completed.
Sponsor:
Collaborator:
Robert Wood Johnson Foundation
Information provided by:
Wake Forest Baptist Health
ClinicalTrials.gov Identifier:
NCT00865774
First received: March 17, 2009
Last updated: June 28, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Alcoholism
Behavioral: Quantity Frequency Model
Behavioral: Targets Subjective Drunkenness
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: The Teachable Moment: Screening and Brief Intervention for Admitted Trauma Patients

Resource links provided by NLM:


Further study details as provided by Wake Forest Baptist Health:

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

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

Enrollment: 333
Study Start Date: January 2009
Study Completion Date: December 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00865774

Locations
United States, North Carolina
Wake Forest University Baptist Medical Center
Winston Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest Baptist Health
Robert Wood Johnson Foundation
Investigators
Principal Investigator: Mary Claire O'Brien, MD Wake Forest School of Medicine
  More Information

Publications:
Anderson JA, Coscia RL, Cryer HG, et al. Injury does not occur by accident. Resources for the optimal care of the injured patient 2006. Chicago, IL: 2006. p. 115-20.
Tanner MA, Wong WH. Data-based nonparametric estimation of the hazard function with applications to model diagnostics and exploratory analysis. J Am Stat Assoc. 1984; 79:174-182.
Andersen P, Gill R. Cox regression model for counting processes: a large sample study. Ann Stat. 1982; 10:1100-1120.

Responsible Party: Mary Claire O'Brien, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00865774     History of Changes
Other Study ID Numbers: IRB00006734
Study First Received: March 17, 2009
Last Updated: June 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest Baptist Health:
Trauma
Alcohol
Brief Intervention

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 24, 2014