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

July 2, 2013 updated by: Memorial Medical Center

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Anticipated)

480

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • Johnstown, Pennsylvania, United States, 15905
        • Memorial Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

60 helmeted and 60 unhelmeted motorcycle riders in each cohort

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Medical Center

Investigators

  • Principal Investigator: Stephen L Miller, MD, FACS, Memorial Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 19, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

July 3, 2013

Last Update Submitted That Met QC Criteria

July 2, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMC 04-18

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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