NCT00164294

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
Last Updated

September 14, 2005

Status Verified

September 1, 2005

First QC Date

September 9, 2005

Last Update Submit

September 9, 2005

Conditions

Interventions

Eligibility Criteria

Age18 Years - 44 Years
Sexall
Age GroupsAdult (18-64)

You may qualify if:

  • Screen Positive for a drinking problem in the ED

You may not qualify if:

  • \<18years or \>44years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Marilyn S Sommers, PhD, RN

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
ECT
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Last Updated

September 14, 2005

Record last verified: 2005-09

Locations