We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00200135
First Posted: September 20, 2005
Last Update Posted: July 3, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Memorial Medical Center
  Purpose
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.

Condition
Craniocerebral Trauma Facial Injuries

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Financial and Clinical Impact of Repeal of the Pennsylvania Helmet Law: A Multi-Center Prospective Study Comparing Helmeted and Non-Helmeted Motorcycle Accident Victims

Resource links provided by NLM:


Further study details as provided by Memorial Medical Center:

Estimated Enrollment: 480
Study Start Date: June 2005
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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)

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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
60 helmeted and 60 unhelmeted motorcycle riders in each cohort
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00200135


Locations
United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Memorial Medical Center
Johnstown, Pennsylvania, United States, 15905
Sponsors and Collaborators
Memorial Medical Center
Investigators
Principal Investigator: Stephen L Miller, MD, FACS Memorial Medical Center
  More Information

Responsible Party: Stephen L Miller, MD,FACS/ Director, Trauma Services, Memorial Medical Center
ClinicalTrials.gov Identifier: NCT00200135     History of Changes
Other Study ID Numbers: MMC 04-18
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: July 3, 2013
Last Verified: July 2013

Keywords provided by Memorial Medical Center:
motorcycle accident
helmet
traumatic brain injury
financial burden

Additional relevant MeSH terms:
Craniocerebral Trauma
Facial Injuries
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries