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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Memorial Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Memorial Medical Center
ClinicalTrials.gov Identifier:
NCT00200135
First received: September 12, 2005
Last updated: February 13, 2009
Last verified: February 2009
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Memorial Medical Center:

Estimated Enrollment: 480
Study Start Date: June 2005
Estimated Study Completion Date: September 2009
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 12, 2005
Last Updated: February 13, 2009
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 16, 2013