Accidents, TrafficPhase 4NCT00300859
Brief Intervention to Increase Safety Belt Use Among ED Patients
A Phase 4 study testing brief motivational intervention in people with Accidents, Traffic, run by Centers for Disease Control and Prevention.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Accidents, Traffic
- What is being tested?
- brief motivational intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2006to Oct 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ED patients greater than 18 years old, speak English, normal mental status, can give free and autonomous consent,
Who cannot join
- patient does not have a telephone or is homeless, altered mental status, is a prisoner, under psychiatric evaluation
About this study
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").
- Conditions
- Accidents, Traffic
- Being tested
- brief motivational intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brief motivational interventionBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
seat belt use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2006 (estimated)
- Study startFeb 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidents, TrafficStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Investigators
- William Fernandez, MD, Principal investigator, Boston University School of Medicine Dept. of Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00300859
- Sponsor's protocol ID
- CDC-NCIPC-0681
- Other IDs
- 1R49CE000681-01
- Status last verified
- Apr 2025
- First submitted
- 8 Mar 2006
- Last updated
- 17 Apr 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Intervention to Increase Safety Belt Use Among ED Patients
- ClinicalTrials.gov ID
- NCT00300859
- Acronym / sponsor ID
- CDC-NCIPC-0681
- Conditions
- Accidents, Traffic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Study start
- Feb 2006
- Study completion
- Oct 2006 (actual)
- First posted
- 10 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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").
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ED patients greater than 18 years old, speak English, normal mental status, can give free and autonomous consent,
Key exclusion criteria (1 listed)
- patient does not have a telephone or is homeless, altered mental status, is a prisoner, under psychiatric evaluation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| brief motivational intervention | Behavioural | – |
Primary outcome
seat belt use
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Fernandez, MD principal investigator
Boston University School of Medicine Dept. of Emergency Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing brief motivational intervention in people with Accidents, Traffic, run by Centers for Disease Control and Prevention.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
seat belt use. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.