Financial and Clinical Impact of Repeal of the Pennsylvania Motorcycle Helmet Law - Tabular View

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

February 13, 2009

Start Date ^ICMJE

June 2005

Estimated Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00200135 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Financial and Clinical Impact of Repeal of the Pennsylvania Motorcycle Helmet Law

Official Title ^ICMJE

Financial and Clinical Impact of Repeal of the Pennsylvania Helmet Law: A Multi-Center Prospective Study Comparing Helmeted and Non-Helmeted Motorcycle Accident Victims

Brief Summary

The purpose of this study is to find out how many helmeted versus non-helmeted motorcycle accident victims (MCA) sustain head and/or face injuries. Also, we will find out how much it costs to get medical care for head and face injuries in helmeted versus non-helmeted motorcycle victims. Finally, we will compare how long it takes helmeted versus non-helmeted motorcycle victims with face and head injuries to return to work.

Detailed Description

This is a prospective, quasi-experimental research study that will compare clinical outcomes of helmeted versus non-helmeted motorcycle victims admitted to trauma centers, as well as victims treated and released from emergency departments.

The primary objective of this study is:

To determine if the financial charges and ratio of cost to charges (RCC), including acute hospitalization, rehabilitation or skilled care, outpatient care, and time to return to work (implying lost wages) is different between helmeted versus non-helmeted motorcyclists with head or face injuries

Secondary objectives include:

To determine if inpatient mean total acute care and downstream charges and RCC are higher for non-helmeted versus helmeted motorcycle victims admitted to three Pennsylvania trauma centers with head and face injuries
To determine the mean time of return to full duty work (at previous level of employment) is shorter for helmeted or non-helmeted motorcycle victims admitted to three Pennsylvania trauma centers with head and face injuries
To determine if non-helmeted or helmeted motorcycle victims admitted to three Pennsylvania trauma centers have increased incidence and severity of head and face injuries
To determine the incidence and severity of non-helmeted motorcycle accident victims is higher than helmeted counterparts treated and released from emergency departments for face and head injuries
To determine if non-helmeted motorcycle victims die at scene or in emergency departments (from head and face injuries) more often than helmeted motorcycle victims
To determine if more helmeted or non-helmeted motorcycle accident victims require no immediate medical care for head and face injuries

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Case Control, Prospective

Condition ^ICMJE

Craniocerebral Trauma
Facial Injuries

Intervention ^ICMJE

Study Arms / Comparison Groups

Treated and released from ED (minor injuries)
Trauma, admitted to the hospital (injured)
Fatalities reported by the coroner (deaths)
Reported by the police (No medical treatment)

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

480

Estimated Completion Date

September 2009

Estimated Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

All English speaking drivers/passengers of motorcycle accidents, 18 years or older, with head or face injuries served by participating study trauma centers, emergency departments or coroners.
All English speaking drivers/passengers of motorcycle accidents, 18 years of age or older, served by Pennsylvania police but did not require acute medical services.

Exclusion Criteria:

Non-English speaking
Served by trauma center, emergency department or coroner, but without haed or face injury
Less than 18 years of age
Moped accidents
Motorized bicycle accidents
Parked motorcycle accidents
Off road motorcycle accidents, not on a public street or highway
Dirtbike or motorcross accidents, involving vehicles not licensed for highway use

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00200135

Responsible Party

Stephen L Miller, MD,FACS/ Director, Trauma Services, Memorial Medical Center

Study ID Numbers ^ICMJE

MMC 04-18

Study Sponsor ^ICMJE

Memorial Medical Center

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Stephen L Miller, MD, FACS

Memorial Medical Center

Information Provided By

Memorial Medical Center

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP