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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00300859
Other study ID # CDC-NCIPC-0681
Secondary ID 1R49CE000681-01
Status Not yet recruiting
Phase Phase 4
First received March 8, 2006
Last updated March 9, 2006
Start date February 2006
Est. completion date October 2006

Study information

Verified date March 2006
Source Centers for Disease Control and Prevention
Contact William Fernandez, MD
Phone 617-414-4927
Email william.fernandez@bmc.org
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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").


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 0
Est. completion date October 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training


Related Conditions & MeSH terms


Intervention

Behavioral:
brief motivational intervention


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Centers for Disease Control and Prevention

Outcome

Type Measure Description Time frame Safety issue
Primary seat belt use
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