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

This study has been completed.
Sponsor:
Information provided by:
Memorial Medical Center
ClinicalTrials.gov Identifier:
NCT00200135
First received: September 12, 2005
Last updated: July 2, 2013
Last verified: July 2013

September 12, 2005
July 2, 2013
June 2005
September 2009   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00200135 on ClinicalTrials.gov Archive Site
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Financial and Clinical Impact of Repeal of the Pennsylvania Motorcycle Helmet Law
Financial and Clinical Impact of Repeal of the Pennsylvania Helmet Law: A Multi-Center Prospective Study Comparing Helmeted and Non-Helmeted Motorcycle Accident Victims

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.

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
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
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Non-Probability Sample

60 helmeted and 60 unhelmeted motorcycle riders in each cohort

  • Craniocerebral Trauma
  • Facial Injuries
Not Provided
  • 1
    Treated and released from ED (minor injuries)
  • 2
    Trauma, admitted to the hospital (injured)
  • 3
    Fatalities reported by the coroner (deaths)
  • 4
    Reported by the police (No medical treatment)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
480
September 2009
September 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00200135
MMC 04-18
No
Stephen L Miller, MD,FACS/ Director, Trauma Services, Memorial Medical Center
Memorial Medical Center
Not Provided
Principal Investigator: Stephen L Miller, MD, FACS Memorial Medical Center
Memorial Medical Center
July 2013

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