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

Primary Purpose

Alcoholism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Quantity Frequency Model
Targets Subjective Drunkenness
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcoholism focused on measuring Trauma, Alcohol, Brief Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wake Forest University Baptist Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Arm number 1 focuses on the traditional quantity frequency model.

Arm number 2 targets subjective drunkenness.

Outcomes

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

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

Full Information

First Posted
March 17, 2009
Last Updated
August 7, 2018
Sponsor
Wake Forest University Health Sciences
Collaborators
Robert Wood Johnson Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00865774
Brief Title
The Teachable Moment: Screening and Brief Intervention for Admitted Trauma Patients
Acronym
TM
Official Title
The Teachable Moment: Screening and Brief Intervention for Admitted Trauma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
Robert Wood Johnson Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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: Screening patients who are admitted to the Trauma Center, and conducting BIs for all who screen positive; Collecting formative qualitative data regarding participants' perceptions of benefits of drunken states, their individual risks, and perceived healthier alternatives; 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; Collecting follow-up data by telephone on self-reported alcohol use and trauma recidivism, using an interviewer-administered assessment; Collecting data on trauma recidivism from ED data, publicly available records, and patient self-report at 6-month telephone follow-up; Surveying trauma staff and physicians at three intervals regarding the process of implementing the new ACS policy, any perceived difficulties, and the perceived impact

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism
Keywords
Trauma, Alcohol, Brief Intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
333 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Arm number 1 focuses on the traditional quantity frequency model.
Arm Title
2
Arm Type
Experimental
Arm Description
Arm number 2 targets subjective drunkenness.
Intervention Type
Behavioral
Intervention Name(s)
Quantity Frequency Model
Intervention Description
The quantitative intervention involves emphasis on tracking and measuring the number of drinks on a weekly basis.
Intervention Type
Behavioral
Intervention Name(s)
Targets Subjective Drunkenness
Intervention Description
Explores factors leading to drunkenness and alternative coping strategies for healthier function.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Claire O'Brien, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

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

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