Clinical trial NCT00200135: Financial and Clinical Impact of Repeal of the Pennsylvania Motorcycle Helmet Law
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Craniocerebral Trauma
Facial Injuries
Keywords: motorcycle accident
helmet
traumatic brain injury
financial burden
Lead sponsor: Memorial Medical Center
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 60 helmeted and 60 unhelmeted motorcycle riders in each cohort

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

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Johnstown
country: United States
facility: Memorial Medical Center
state: Pennsylvania
Study officials:
affiliation: Memorial Medical Center
name: Stephen L Miller, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References: