ED Intervention to Reduce Risky Behaviors in Drivers
Primary Purpose
Alcohol Use
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Brief intervention
Sponsored by

About this trial
This is an interventional educational/counseling/training trial for Alcohol Use
Eligibility Criteria
Inclusion Criteria: Screen Positive for a drinking problem in the ED Exclusion Criteria: <18years or >44years old
Sites / Locations
- University of Cincinnati
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00164294
First Posted
September 9, 2005
Last Updated
September 9, 2005
Sponsor
Centers for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT00164294
Brief Title
ED Intervention to Reduce Risky Behaviors in Drivers
Official Title
ED Intervention to Reduce Risky Behaviors in Drivers
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Centers for Disease Control and Prevention
4. Oversight
5. Study Description
Brief Summary
Disability and death from injury remain a persistent problem in the U.S. and risk-taking behaviors are known to contribute to injury. Healthy People 2010 set goals to reduce deaths caused by injury: "Motor vehicle crashes are often predictable and preventable. Increased use of seat belts and reductions in driving while impaired are two of the most effective means to reduce the risk of death and serious injury of occupants in motor vehicle crashes." One preventive strategy is to establish screening and intervention procedures that can be administered in the ED to young adults who have risky driving practices and problem drinking. Goal: The specific aim of this prospective, randomized controlled trial is to test the effectiveness of a brief intervention to limit risky driving behaviors (risky driving practices, lack of seat belt compliance) and problem drinking in drivers during an ED visit. In addition, the trial will result in a benefit-cost analysis from the perspectives of both society as a whole and hospitals in particular. Methods: Young adults 18 to 44 years will be screened for problem drinking and risky driving practices during an ED visit. Subjects who screen positive for problem drinking and risky driving will be randomized to one of three groups: No Contact Control Group (NCG: after informed consent, subjects receive no screening or intervention until 12 months after injury). Contact Control Group (CCG: subjects screened at baseline and every three months for 12 months but no intervention), and a Brief Intervention Group (BIG: subjects receive screening and brief intervention with data collection points every three months for 12 months). A total of 133 subjects per group (N=400) will be enrolled. The intervention will consist of a 20 minute nurse visit in the ED and a booster intervention at 7-10 days after ED discharge. All subjects will be telephoned at 3, 6, 9, and 12 months by interviewers blinded to condition. Outcomes of interest include reported alcohol use, risky driving behaviors, driving citations, adverse health outcomes, and costs (health care utilization, property damage, travel delays, lost work productivity, criminal justice expenses, and monetarized adverse health outcomes). Analysis: Power analysis suggests that 133 subjects in each arm of the trial will have sufficient power to detect a difference of the main outcome variables of interest. A variety of regression techniques, including individual growth curve modeling and event history analysis, will be used to test the proposed hypotheses.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use
7. Study Design
Primary Purpose
Educational/Counseling/Training
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Brief intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Eligibility Criteria
Inclusion Criteria:
Screen Positive for a drinking problem in the ED
Exclusion Criteria:
<18years or >44years old
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marilyn S Sommers, PhD, RN
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24814717
Citation
McDonald CC, Sommers MS, Fargo JD. Risky driving, mental health, and health-compromising behaviours: risk clustering in late adolescents and adults. Inj Prev. 2014 Dec;20(6):365-72. doi: 10.1136/injuryprev-2014-041150. Epub 2014 May 9.
Results Reference
derived
Learn more about this trial
ED Intervention to Reduce Risky Behaviors in Drivers
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