NCT00300859

Brief Summary

DESCRIPTION (adapted from applicant's abstract): Injury control experts suggest that consistent SBU is the most effective means for motorists to reduce1he risk of death or serious injury in a crash. Sadly, the SBU prevalence among Massachusetts' residents is among the lowest in the nation. In accord with Healthy People 2010, Objective 15-19, and the CDC's Injury Research Agenda, the investigator will test the utility of a brief intervention to increase SBU among ED patients with self-reported SBU that IS less than "always". A secondary aim is to determine if the brief intervention is more effective among persons being treated for a motor vehicle crash (MVC)-related injury during a "teachable moment" than other non-injured ED patients receiving the same intervention. The research staff will systematically sample ED patients, screening for SBU among eligible participants during a 3-month period. Upon obtaining verbal consent, researchers will ask participants to complete a self-administered screening form on health and safety issues, including SBU. Patients that screen positive, (i.e., give an answer of less than "always use" safety belts) on a SBU screening question will be asked to participate in an intervention to promote health and safety among ED patients. Participants will be reimbursed for their time, and asked to do the following: to give written informed consent via IRB-approved forms and a HIPAA release form; complete an intake form, and agree to a follow-up phone interview at 3 and 6 months post-enrollment. Participants will be randomized into one of two groups: an Intervention Group that will receive a brief intervention designed to increase SBU, and a Control Group that will receive only standard care. Research staff will contact participants for a follow-up phone survey at 3 and 6 months to test the hypothesis that individuals randomized to the Intervention Group will have a higher self-reported SBU than those in the Control Group that received only standard care. Likewise, for the secondary (exploratory) analysis, the hypothesis is that among those treated for MVC-related trauma--and randomized to the intervention group--will have a higher self-reported SBU than others with non MVC-related trauma due to a greater receptivity to brief intervention techniques during the ED visit (i.e. the "teachable moment").

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2006

Shorter than P25 for phase_4

Status
withdrawn

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

Study Start

First participant enrolled

February 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 8, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 10, 2006

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

April 17, 2025

Status Verified

April 1, 2025

First QC Date

March 8, 2006

Last Update Submit

April 14, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • seat belt use

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ED patients greater than 18 years old, speak English, normal mental status, can give free and autonomous consent,

You may not qualify if:

  • patient does not have a telephone or is homeless, altered mental status, is a prisoner, under psychiatric evaluation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • William Fernandez, MD

    Boston University School of Medicine Dept. of Emergency Medicine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

March 8, 2006

First Posted

March 10, 2006

Study Start

February 1, 2006

Study Completion

October 1, 2006

Last Updated

April 17, 2025

Record last verified: 2025-04