Kathleen R. Bell, MD
University of Washington
1959 NE Pacific Street
Box 356490
Seattle, WA 98195-6490
Phone: 206-685-0935
Fax: 206-685-3244
E-mail:
krbell@u.washington.edu
Project Title: The Effect of Telephone Follow-up on
Outcome in Mild TBI
Project Period: 09/01/03 – 08/31/06
Description: Mild traumatic brain injury (MTBI) occurs
in more than 1 million persons per year in the United
States. This number is likely to be an underestimation
because of the problems in identifying MTBI cases.
Although spontaneous improvement is expected, recovery
can be prolonged, and 15% or more persons with MTBI
still have symptoms at 6 months. But few interventions
have been studied in this population. This project will
use a randomized, controlled study to compare the
efficacy of two methods of preventive MTBI management to
improve the rate of recovery, prevent persistent
symptoms, and improve function. Effective early
treatment and interventions aimed at preventing
complications after MTBI may shorten morbidity and
reduce costs associated with persistent symptoms or
disability.
Aim 1 will compare the effect of scheduled telephone
contacts or a toll-free information line with the effect
of usual care on the persistence of symptoms in persons
with MTBI. Researchers will recruit and assess subjects
in the emergency department (ED) of a Level 1 trauma
center and will randomize them into one of three groups:
usual care, usual care and toll-free number for
information, and usual care, toll-free number, and
scheduled telephone follow-up. All three groups will be
assessed at 6 months by telephone for presence and
duration of symptoms.
Aim 2 will examine the effect of scheduled telephone
contacts or a toll-free information line, compared with
usual care, on function after MTBI by measuring in all
three groups health and emotional states, daily
scheduled activities, employment, and satisfaction with
life at 6 months.
Aim 3 will examine effects by gender or race. The study
will determine the effect on persons with MTBI of two
low-cost, easily implemented techniques and compare
their outcomes with regard to symptom persistence and
function.
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Jeanne E. Dise-Lewis, PhD
University of Colorado Health Sciences Center
The Children’s Hospital
1056 East 19th Avenue, B285
Denver, CO 80218
Phone: 303-861-6642
Fax: 303-764-8048
E-mail:
Jeanne.diselewis@tchden.org
Project Title: An Investigation of Outcomes
Associated with Pediatric TBI
Project Period: 08/01/04 – 07/31/07
Description: Traumatic Brain Injury (TBI) is the leading
cause of both death and disability for children and
youth in the United States. Half of the estimated 5.3
million persons in the United States who have TBI are
under age 18. Each year, approximately 3,000 children
die from TBI and 29,000 of them survive injuries in the
moderate to severe range. Approximately 30,000 children
are permanently disabled annually as a result of TBI,
which significantly impacts their physical, cognitive,
and psychosocial competencies. An estimated additional
900,000 children have "mild" TBIs each year; the impact
of these injuries on development and learning is largely
unknown, but potentially significant.
The University of Colorado Health Sciences Center (UCHSC)
and The Children's Hospital, Denver will conduct a
comprehensive, longitudinal study of the course of mild,
moderate, or severe TBI, from initial injury through
long-term community reintegration. Researchers will also
conduct a randomized, controlled comparison of four
interventions to assess the impact on long-range
psychosocial outcomes. This study will establish a
comprehensive database of variables related to
psychosocial TBI outcomes in children and youth and
establish interventions that may improve these outcomes.
The UCHSC will work closely with the Colorado Department
of Health's Programs for Children with Special
Healthcare Needs.
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Dawn Ehde, PhD
University of Washington
325 9th Avenue, Box 359740
Seattle, WA 98104
Phone: 206-731-2811
Fax: 206-731-8580
E-mail:
ehde@u.washington.edu
Project Title: Chronic Pain Prevention after Spinal
Cord Injury (SCI) and Limb Loss
Project Period: 8/01/04 – 07/31/07
DESCRIPTION: The broad, long-term objective of this
project is to reduce the occurrence and associated
suffering of chronic pain secondary to either spinal
cord injury (SCI) or limb loss (LL). This research aims
to accomplish the following:
- Compare how two in -hospital provided self-management
interventions for pain management (either a hypnotic
analgesia treatment or a cognitive treatment) and a
control education treatment affect pain intensity, pain
interference with activities, psychological distress,
and quality of life among persons with a new SCI or LL
who are at risk for chronic pain;
- Test possible biopsychosocial variables that can help
determine who might benefit most from future
interventions and assist researchers in further
developing interventions to maximize efficacy;
- Result in treatment manuals to facilitate replication
(in future research) and dissemination (among
clinicians).
These aims will be accomplished by a two-phase study:
Phase I is a surveillance study in which individuals
with a new onset of SCI or LL will be followed
longitudinally from the acute care setting through 6
months post-injury (the time by which chronic pain
develops). Biopsychosocial predictor variables will be
collected within 1 week after SCI or LL injury to
develop a protocol for identifying participants who
develop acute pain and associated risk factors.
Phase II will be a randomized clinical trial in which
persons who are identified as having severe acute pain
following their injury will be assigned to one of three
pain treatment conditions: a cognitive restructuring
intervention, a hypnotic analgesia intervention, or an
education control intervention. All of the eight-session
interventions of individual therapy are adapted from
currently practiced and empirically supported
interventions for chronic pain where pain is the primary
complaint. This study is unique in that these
interventions have not been evaluated for their
effectiveness in the prevention of chronic pain and
related disability, nor have they been tested in the SCI
or LL populations using a randomized clinical trial
design. Measures of pain intensity, psychological
functioning, pain interference with activities,
participation, medical services use, and costs will be
collected at pre- and post-treatment and at 3- and
6-month follow up.
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Jess Kraus, MPH, PhD
Regents of the University of California
10920 Wilshire Boulevard, Suite 1200
Los Angeles, CA 90024
Phone: 310-794-2706
Fax: 310-794-0787
E-mail:
jfkraus@ucla.edu
Project Title: Epidemiology and Costs of Mild
Traumatic Brain Injury in Nonhospitalized Patient
Populations
Project Period: 9/30/02 – 9/29/05
Description: This research examines the incidence,
costs, and long-term consequences of mild traumatic
brain injury (MTBI) among population-based patient
groups presenting to two trauma centers and three
non-trauma-designated hospitals in San Diego County,
California. The following specific aims will accomplish
this objective:
- Estimate by patient demographics and mechanism of
injury the rate of MTBI occurring in two trauma center
catchment areas and three non-trauma-designated
emergency department service areas.
- Estimate the medical expenditures associated with
MTBI and the indirect costs of lost work and household
production time;
- Describe the 3- and 6-month outcomes experienced by
MTBI patients, compared with patients with an injury not
sustained to the head, controlling for patient
demographics and pre-morbid conditions.
This research will describe the natural course of MTBI
in non-hospitalized patient groups where little research
has been concentrated. A prospective cohort study design
will be used to identify, enroll, and follow
non-hospitalized MTBI patients who present to the
participating facilities. The target populations of
interest will be patients diagnosed with MTBI who are
not admitted to the hospital and patients with an injury
to a body region other than the head who are not
admitted to the hospital. Posttraumatic outcomes of MTBI
will focus on both personal disabilities and those that
affect how the MTBI patient interacts and functions in
the environment. Researchers will use hospital records,
emergency medical service reports, and patient
interviews to obtain information about the medical and
rehabilitative services received by each enrolled
patient and the pre-injury factors, costs, and
post-injury outcomes needed to document the natural
course of MTBI. Both tabular analysis and longitudinal
regression modeling will be used to compare outcomes
across the target population groups.
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Harvey S. Levin,
PhD
Baylor College of Medicine
One Baylor Plaza
Houston, TX 77030
Phone: 713-798-7566
Fax: 713-798-6898
E-mail:
hlevin@bcm.tmc.edu
Project Title: Community-based Case Management of
Mild to Moderate Traumatic Brain Injury
Project Period: 9/30/01–9/29/05
Description: Patients with mild to moderate traumatic
brain injury (TBI) often develop secondary conditions
including major depressive disorder (MDD), post
concussive disorder (PCD), or post traumatic stress
disorder (PTSD) within 6 months after injury. This study
determines if case management of TBI patients during the
first 3 months after injury can decrease the occurrence
of secondary conditions. Year 1 of the study identifies
and assesses TBI patients at risk for developing
secondary conditions. Years 2 and 3 of the study
randomize TBI patients at risk for developing secondary
conditions into case management and standard care
management groups. Outcome measures include the
Structured Clinical Interview for DSM-IV, the CES-D, the
Visual Analog Scale of Depression, a post concussion
symptom checklist, the PTSD Checklist, a series of
cognitive tests, the extended Glasgow Outcome Scale,
Community Integration Questionnaire, and the SF-36.
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Ellen J. MacKenzie, PhD
The Johns Hopkins University
Bloomberg School of Public Health
Health Policy and Management
624 N. Broadway
Hampton House Room 554
Baltimore, MD 21205
Phone: 410-614-4025
Fax: 410-614-2797
E-mail:
emackenz@jhsph.edu
Project Title: Health-related Quality of Life in
Trauma: A Supplement to NSCOT
Project Period: 09/30/03–09/29/04
DESCRIPTION: Increasingly, generic health status
measures are being used to quantify the non-economic
burden of illness and injury and to measure the impact
of interventions at both clinical and policy levels. But
most of these generic measures are undefined for people
who die. This study will examine two approaches for
incorporating deaths into an analysis of trauma outcomes
and will use these approaches for estimating the burden
of injury in years of healthy life lost (YHLL). The
first approach uses measures that incorporate a value
for death together with preference-based assessments of
health. The second approach transforms well-known,
non-preference-based descriptive measures of health into
probabilities that a person will be "healthy" in the
future. The study will supplement the ongoing National
Study on the Costs and Outcomes of Trauma Care (NSCOT).
The aims of the study follow:
- Develop methods for transforming non-preference-based
measures of health status (e.g., EVGGFP, ADL/IADL,
SF-36) into new measures that include a defensible value
for death;
- Examine the distributional properties and validity of
the measures developed together with published
preference-based measures of function and quality of
life that can be derived from the NSCOT study, to
include the SF-6D, the Health and Activity Limitations
Score (HALEX score), the Functional Capacity Index
(FCI), and modified versions of both the HUI-3 and the
EQ 5-D;
- Combine information on the incidence and outcome of
major trauma with estimated life expectancy from life
tables to derive population-based estimates of the
burden of major trauma overall and for specific
subgroups of the major trauma population (i.e.,
traumatic brain injury or motor vehicle-related trauma).
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Ronald F. Maio, DO, MS
Michigan Public Health Institute
Department of Emergency Medicine
University of Michigan Health System
300 NIB 2D06, Box 0437
Ann Arbor, MI 48109-0437
Phone: 734-936-1724
Fax: 734-936-2706
E-mail:
ronmaio@med.umich.edu
Project Title: Nonhospitalized TBI: Michigan
Incidence Impact and Cost
Project Period: 10/01/03–9/30/06
Description: Approximately 1.5 million Americans each
year are involved in motor vehicle crashes, falls,
recreation activities, and violence-related events that
result in a traumatic brain injury (TBI). Each year
nationwide, more than 50,000 people die because of TBI
and 5.3 million (2% of the population) live with a
disability resulting from TBI. Despite the increasing
rate of hospitalization for TBI, there are very few
emergency department (ED) based studies of TBI. Mild TBI
(MTBI) is recognized as an important health problem, but
there is inadequate data to determine accurately the
extent of MTBI among non-hospitalized injuries and the
outcomes associated with MTBI among non-hospitalized
patients.
This research will determine the incidence of, and
outcomes associated with, non-hospitalized mild TBI
(MTBI). The study will use three sources of information:
a unique statewide ED injury surveillance database,
statewide claims data, and an ED-based prospective
cohort study of minor-injury patients.
Primary aims:
- Determine the prevalence and characteristics of
non-hospitalized MTBI patients;
- Determine the outcomes associated with
non-hospitalized MTBI, in particular post-concussive
syndrome (PCS);
- Compare the level of agreement between case
identification of non-hospitalized MTBI using
surveillance ICD-9-CM criteria and case identification
protocols in the ED cohort study.
Secondary aims:
- Determine the costs and services associated with
non-hospitalized MTBI;
- Compare hospitalized and non-hospitalized TBI cases
on demographic variables and the nature and severity of
injuries.
The project will be conducted using two broad study
designs: (1) analysis of secondary data using Michigan
ED data and Medicaid and private insurers’ data systems
to determine the incidence, nature, and causes of MTBI,
costs incurred, and services used by non-hospitalized
TBI individuals; and (2) a panel study of a sample of
adults treated for TBI at an ED, subsequently
discharged, and surveyed four times within a period of 1
year after their injury event. Self-reported survey
measures will include demographics, health status, PCS
and cognitive symptoms, and an alcohol-related
assessment.
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Melissa McCarthy, ScD
The Johns Hopkins University
Department of Emergency Medicine
1830 East Monument Street, Suite 6-100
Baltimore, MD 21205
Phone: 410-502-8877
Fax: 410-502-8881
E-mail: mmccarth@jhmi.edu
Project Title: Measuring Children’s Health Posttraumatic
Brain Injury
Project Period: 9/30/01–9/29/04
Description: Traumatic brain injury (TBI) can significantly
affect a child’s health and future development. The health
of children following TBI needs to be monitored by using a
standardized instrument. This study evaluates the Pediatric
Quality of Life Inventory (PedsQL) as a surveillance
instrument for monitoring the physical and psychosocial
health outcomes of children after TBI. The PedsQL cognitive
function subscale is compared with the Behavioral Rating
Inventory of Executive Function (BRIEF). Children ages 5 to
15 admitted to one of three pediatric trauma centers for
treatment of TBI or an extremity fracture are eligible for
participation. The health status of the child is measured
through a telephone interview within 2 weeks of the injury
(baseline) and at 3 and 12 months after the injury. The
validity of the PedsQL scales and BRIEF are examined by
comparing scores attained by groups of children with varying
severity of head injury and children with and without TBI.
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Michael J. Mello, MD, MPH
Rhode Island Hospital
Injury Prevention Center
Room 334 593 Eddy Street
Providence, RI 02903
Phone: 401-444-2685
Fax: 401-444-2249
E-mail:
mjmello@lifespan.org
Project Title: Phone Intervention for Hazardous Ethanol
Use in Emergency Department (ED) Motor Vehicle Crash
Patients
Project Period: 09/01/03–08/31/06
Description: Injury is the leading cause of death into the
third decade of life, and alcohol is an enormous risk factor
for injury. Alcohol is involved in 40% of fatal motor
vehicle crashes (MVC). The long-term goal of this research
program is to reduce alcohol-related injuries and other
negative alcohol-related consequences among patients injured
in a MVC who present for treatment in a hospital ED. An ED
visit provides an ideal teachable moment in which to
intervene for an alcohol-use problem. A prior study by
researchers at this institution has shown that a brief
motivational intervention administered in the ED, followed
by a booster session, reduces alcohol-related injuries and
other negative consequences at a 12-month follow-up for
sub-critically injured, harmful/hazardous drinkers. The
researchers will study whether such an intervention given by
telephone will be effective. Contrary to the generally held
notion that counseling requires face-to-face interaction,
research finds that telephone counseling and intervention
can effectively treat a range of health and mental health
conditions. Telephone intervention is also likely to be more
cost-effective.
The study’s primary aim is to test whether a brief
motivational intervention given by telephone to
harmful/hazardous drinkers injured in a MVC will reduce
alcohol-related injuries and other negative alcohol-related
consequences. Researchers will randomly assign 286 hazardous
drinkers injured in a MVC and treated in the ED to telephone
brief motivational intervention or standard care.
Re-assessment will be at 3 and 12 months to measure changes
in reducing alcohol-related injuries and other
alcohol-related negative consequences. A secondary aim is to
test for patient characteristics that may moderate
effectiveness of the intervention. The study will examine if
effect is dependent on the extent of hazardous drinking; or
on attribution of injury to alcohol; or on the subject's
self assessment of the pros and cons of alcohol use at the
time of their injury.
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Richard Mullins, MD
Oregon Health Sciences University
Department of Surgery
3181 SW Sam Jackson Park Road
Mail Code L223A
Portland, OR 97201 3098
Phone: 503 494 5300
Fax: 503 494 8884
E-mail: mullinsr@ohsu.edu
Project Title: Measuring Quality of Care Delivered in a
Trauma System
Project Period: 09/01/01–8/31/04
Description: Oregon’s statewide trauma system needs provider
decision rules for the acutely injured—specifically, for
elderly patients and brain-injured patients in rural
communities. The functional recovery of older injured
patients needs to be assessed and the processes of care need
to be identified. This project will develop a provider
decision rule for patient transfer in an established trauma
system, assess initial treatment, and identify process of
care. A provider decision rule will be developed that
identifies brain-injured patients in Level 3 and Level 4
trauma centers who would benefit from immediate transfer to
a higher level of care. Researchers will assess the
functional recovery of older injured patients, identify
processes of care interventions, and measure providers’
compliance with a transfer decision. Researchers will use an
SF-36 survey to measure older injured patients, and they
will also identify processes of provider care decisions.
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Marilyn S. Sommers, RN, PhD, FAAN
University of Cincinnati
P.O. Box 210038
Cincinnati, OH 45521-0038
Phone: 513-558-5268
Fax: 513-558-5647
E-mail: sommers@uc.edu
Project Title: Emergency Department (ED) Intervention
to Reduce Risky Behaviors
Project Period: 09/01/03–08/31/06
Description: Disability and death from injury remain a
persistent problem in the United States, and risk-taking
behaviors are known to contribute to injury. Healthy
People 2010 set goals to reduce deaths caused by injury,
including motor vehicle crash-related injuries: "Motor
vehicle crashes are often predictable and preventable.
Increased use of seat belts and reductions in driving
while impaired are two of the most effective means to
reduce the risk of death and serious injury of occupants
in motor vehicle crashes." One preventive strategy to
reduce this risk is to establish screening and
intervention procedures that can be administered in the
emergency department (ED) to young adults who have risky
driving practices and alcohol-use problems.
The specific aim of this prospective, randomized
controlled trial is to test the effectiveness of
administering brief intervention in the ED to limit
risky driving behaviors (i.e., risky driving practices,
lack of seat belt use) and problem drinking in drivers.
In addition, the trial will result in a cost-benefit
analysis from the perspectives of both society as a
whole and hospitals in particular.
Young adults ages 18 to 44 will be screened during an ED
visit for problem drinking and risky driving practices.
Subjects who screen positive for problem drinking and
risky driving will be randomized to one of three groups:
No Contact Control Group (after informed consent,
subjects receive no screening or intervention until 12
months after injury); Contact Control Group (subjects
screened at baseline and every 3 months for 12 months,
but receive no intervention); and a Brief Intervention
Group (subjects receive screening and brief intervention
with data collection points every 3 months for 12
months). In each group, 133 subjects will be enrolled
(N=400). The intervention will consist of a 20-minute
nurse visit in the ED and a booster intervention at 7 to
10 days after ED discharge. All subjects will be
telephoned at 3, 6, 9 and 6 months by interviewers
blinded to condition.
Outcomes of interest include reported alcohol use, risky
driving behaviors, driving citations, adverse health
outcomes, and costs (i.e., health care use, property
damage, travel delays, lost work productivity, criminal
justice expenses, and monetarized adverse health
outcomes).
Power analysis suggests that 133 subjects in each arm of
the trial will have sufficient power to detect a
difference in the main outcome variables of interest. A
variety of regression techniques, including individual
growth curve modeling and event history analysis, will
be used to test the hypotheses.
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Shari L. Wade, PhD
Cincinnati Children’s Hospital Medical Center
Division of Pediatric Rehabilitation
3333 Burnet Avenue
Cincinnati, OH 45229-3039
Phone: 513-636-7480
Fax: 513-636-7360
E-mail:
Shari.wade@cchmc.org
Project Title: A Trial of Two Online Interventions
for Child Brain Injury
Project Period: 09/30/03–09/29/06
Description: Moderate to severe traumatic brain injury
(TBI) in children is a significant family stressor and
results in increased caregiver burden, impaired
psychological adjustment among caregivers, and
deteriorating family functioning. Empirically based
interventions to address family needs following TBI are
limited, and access to skilled therapists can be
restricted by distance and finances. This project seeks
to address these needs by testing the efficacy of two
contrasting models of online intervention for families
of children with moderate to severe TBI: individualized
online Family Problem Solving Therapy (FPS) and online
Case Management and Multi-Family support group (CM).
Although both aim to reduce caregiver stress and burden,
the treatments have different primary targets (FPS uses
cognitive appraisals and problem solving; CM provides
information and support). Treatments also differ in
intensity of therapeutic contact and cost of
implementation.
This study will examine the efficacy of these two online
treatments in a randomized trial comparing the effects
of FPS and CM to the effects of standard care (SC).
Primary outcomes include problem-solving skills,
injury-related stress and burden, caregiver depression
and anxiety, and parenting stress. Participants will
include the families of children ages 5 to 16 who have
experienced a moderate to severe TBI between 1 and 12
months before study participation. Families will be
randomly assigned to one of three conditions: FPS, CM,
or SC. Group differences will be examined using a
multi-variety approach to analysis of covariance,
controlling for injury severity, child's age,
sociodemographic status, and time since injury. It is
hypothesized that there will be less injury-related
stress, lower levels of anxiety and depression, and less
parenting stress in the two intervention groups than in
the standard care group and that FPS will be associated
with better outcomes than will CM in families with high
levels of child-related stress and family dysfunction at
baseline. The overarching goal is to identify effective
treatments for reducing psychological distress in
caregivers, enabling the family to optimally support the
child's recovery from TBI.
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Connie Jean Potter
National Foundation for Trauma Care
230 Commerce, Suite 210
Irvine, CA 92602
Email:
connie@traumacare.com
Project Title: The Study of the Impact of a Terrorist
Attack on Individual Trauma Centers
Project Period: 9/01/05–8/31/06
Description: Trauma Centers have historically functioned
as critical medical resources and communication hubs for
both natural and human-caused catastrophes. They were
organized so that injured patients are rapidly triaged,
assessed, and treated, as tested in the 1993 and 2001
World Trade Center terrorist attacks, the attack on the
Oklahoma City Murrah Building, and natural disasters of
all types nationwide. This capability will vary where
trauma systems are not developed or fully implemented,
or where trauma centers are economically threatened or
have few resources. Despite their role in
disaster/terror response, a 2004 NFTC survey of
EMS/trauma systems identified only two states (FL, NC)
that had provided any direct fiscal support for trauma
system preparedness for terror attacks, and those
amounts allocated were meager. There has been no
national evaluation of the effect of a terrorist blast
attack on a trauma center. Therefore, they lack
practical examples to help them prepare for the
resultant mass casualties and will benefit from
information from highly performing trauma systems that
can be adapted to any trauma center’s unique
circumstances.
This project addresses the “Healthy People 2010” focus
area(s) of Injury and Violence Prevention and will occur
in two phases. During Phase I, researchers will develop
and conduct a survey of all known verified, designated,
or functional level I and II trauma centers to identify
the degree to which they meet key characteristics of a
well prepared trauma center in the event of a blast-type
terror attack, including one with the potential for
biological, chemical, nuclear agents and other hazards.
Researchers will visit selected trauma centers, that
will provide appropriate documents, and participate in a
summary review of their preparation for a blast-type
terror attack as defined in the grant as part of Phase
II. Trauma centers need templates from highly performing
trauma centers and best practices for preparedness to
meet the needs of the public in the event of a
blast-type terror attack.
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Kassam-Adams, Nancy
Joseph Stokes, Jr. Research Institute
3615 Civic Center Boulevard
Philadelphia, PA 19104-4318
Email:
nlkaphd@mail.med.upenn.edu
Project Title: Stepped Preventive Care to Reduce the
Impact of Acute Pediatric Injury
Project Period: 9/1/2006 – 8/31/2010
Importance: 1 in 6 children with unintentional injuries
develop persistent, impairing symptoms of post-traumatic
stress disorder (PTSD) but most go undiagnosed and
untreated. PTSD and other sequelae can have significant
impact on health and functional outcomes, yet medical
providers' awareness of injury related traumatic stress
is limited. Hospital trauma programs offer unique
opportunities for secondary prevention of persistent
psychosocial distress and promotion of optimal health
outcomes for injured children. Expert consensus
recommendations for PTSD prevention call for stepped
care incorporating screening, follow-up with those at
risk, and evidence-based interventions that are matched
to individual need. Despite the documented impact of
pediatric injury-related PTSD, no such program has been
evaluated for injured children.
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Objectives: We propose a randomized effectiveness trial
to address the following specific aims:
- Evaluate the impact of the intervention on
psychosocial outcomes (PTSD and depression symptoms);
- Evaluate its impact on health outcomes (adherence to
discharge instructions, health-related quality of life);
- Provide preliminary data to inform cost-effectiveness
analyses: describe the costs of providing the
intervention and describe its impact on subsequent
health service utilization. We hypothesize that at-risk
children receiving the intervention will have lower PTSD
and depression scores, better health outcomes, and more
appropriate use of post-injury health services.
Study Design: Randomized controlled trial comparing
Stepped Preventive Care intervention to usual care, with
baseline, 6 week, and 6 month assessments.
Setting: Urban Level I Pediatric Trauma Center.
Participants: 270 children age 8 to 17 admitted for
unintentional injury.
Interventions: Stepped Preventive Care intervention for
at-risk injured children.
Outcome Measures: Assessments 6 weeks and 6 months
post-injury will evaluate PTSD and depression symptoms
in children and parents, adherence, and health-related
quality of life. Health record data will gauge adherence
with discharge instructions and health service
utilization over the 6 months post-injury.
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MacKenzie,Ellen J.
Bloomberg School of Public Health
615 N. Wolfe Street
Baltimore, MD 21205
Email:
emackenz@jhsph.edu
Project Title: Improving Trauma Outcomes: A Patient
Centered Approach
Project Period: 9/1/2006 – 8/31/2010
Importance: Despite substantial improvements over the
last two decades in the organization and delivery of
trauma care, severe injuries often result in poor long
term functional outcomes for working age individuals.
Several studies have highlighted the limits of medical
treatment alone and demonstrated that larger
Improvements in outcome will only be possible through
interventions that also address the psychosocial needs
of patients and assist them in self-managing the
multi-factorial consequences of their injury.
Intervention: It is in this context that the American
Trauma Society developed the Trauma Survivor's Network (TSN)
Program, a patient centered intervention designed to
fill critical gaps in the care and rehabilitation of
trauma survivors. The TSN program consists of four
integrated components - health care provider training,
efficient access to information and referral, a peer
support program, and a self management course – linked
together through a customized Information Technology
application.
Objectives: The purpose of this study is to evaluate the
TSN. We will: (1) determine the use and satisfaction
with services made available through
The TSN Program; and, (2) evaluate the effectiveness of
the TSN Program in improving primary, secondary and
intermediary outcomes for trauma patients.
Study Design and Participants: The prospective clinical
trial will use a pretest-post-test lagged-control design
to evaluate the TSN. A total of 324 patients will be
enrolled prior to implementation of the TSN at two Level
I trauma centers. These individuals will serve as the
control group and their outcomes assessed at 9 months
post-injury. Following implementation of the TSN at both
trauma centers, a second cohort of 540 patients will be
enrolled and followed at 9 months post-injury. These
individuals will serve as the intervention group.
Outcomes: Primary measures of effectiveness will
include: self-reported pain, anxiety, PTSD, depressed
mood, and positive mood. Secondary outcome measures
include: function, return to usual major activity and
quality of life. Improvements in primary and secondary
outcomes will result through the impact of the
intervention on self efficacy, patient activation and
knowledge, catastrophizing and social support. If shown
to be effective, the TSN will provide an additional
critical component to the care now available in trauma
centers throughout the country and ensure comprehensive
patient centered trauma management to improve long-term
outcomes and quality of life.
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Holmes, James Frederick
Office of the Vice Chancellor for Research
Sponsored Programs, 118 Everson Hall
One Shields Avenue
Davis, CA 95616
Email:
jfholmes@ucdavis.edu
Project Title: Clinical Decision Rule to Identify
Children with Intra-abdominal Injuries
Project Period: 9/1/2006 – 8/31/2009
Importance: Trauma is the leading cause of death in
children and intra-abdominal injuries (IAI) are a
frequent cause of morbidity and mortality due to trauma.
Some IAIs are difficult to identify and failure to
identify these injuries results in preventable morbidity
and mortality. Abdominal computerized tomography (CT) is
the reference standard for the diagnosis of IAl. CT
scanning, however, has important risks, primarily the
risk of development of radiation-induced malignancy. For
every 1,500 children undergoing abdominal CT scanning,
approximately one child will die from a malignancy
induced by the radiation and up to three additional
children will develop non-fatal malignancies from this
exposure. Only ~10% of abdominal CT scans currently
performed on children with trauma demonstrate IAIs, thus
CT scanning is used inefficiently.
Objectives: The objective of this study is to develop
highly sensitive, specific and generalizable decision
rules for the evaluation of children seen in emergency
departments (EDs) with blunt abdominal trauma. These
decision rules may then serve to generate
evidence-driven guidelines for the evaluation of these
children, and when implemented will result in more
efficient use of CT scans.
Study Design: This will be a prospective, multi-center,
observational study of children with blunt abdominal
trauma.
Setting: Children with blunt abdominal trauma seen at
one of 17 hospitals in the Pediatric Emergency Care
Applied Research Network (PECARN) will be enrolled over
a two year period. The EDs of the PECARN evaluate more
than 900,000 children of diverse geographic and
racial/ethnic background annually.
Participants: We will enroll ~ 9,774 children with
significant blunt torso trauma, including 900 children
with IAl.
Outcome Measures: The primary outcome for this study
will be IAI in need of acute intervention (IAI resulting
in death, or an IAI in need of any of the following:
laparotomy, blood transfusion, angiographic embolization,
or IV hydration).
Interventions/Data analysis: The patients' history,
physical examination findings and laboratory results at
ED evaluation will be analyzed using recursive
partitioning to generate a clinical decision rule(s) for
the identification of children at high risk and
near-zero risk of IAI in need of acute intervention. The
decision rule(s) will lead to more efficient use of
abdominal CT in those children at risk for IAIs, and a
decrease in use in those at near-zero risk of IAI,
ultimately resulting in more efficient, safe and
effective care of injured children.
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Lerner, E. Brooke
University of Rochester
601 Elmwood Ave.
Box 655
Rochester, NY 14642
Email:
e.lerner@rochester.edu
Project Title: Evaluation of the Mechanism of Injury
Components of the Trauma Triage Criteria
Project Period: 9/1/2006 – 8/31/2009
Transporting patients with severe trauma to trauma
centers can reduce their risk of death. Emergency
Medical Service (EMS) providers must appropriately
identify which patients will benefit from the special
resources of a trauma center. This requires them to have
evidence based trauma triage tools. This study examines
the most commonly used tool, the American College of
Surgeon's Field Triage Criteria. Specifically, we will
evaluate the mechanism of injury component of the
Criteria to determine which of the listed conditions are
predictive of trauma center need. The specific aims are:
(1) to determine which patients with traumatic injuries,
who meet any of the conditions under the mechanism of
injury component of the Criteria need a trauma center;
(2) to identify thresholds for the measurable conditions
under the mechanism of injury component that are the
best predictors of trauma center need; and, (3) to
determine the accuracy of field provider estimates of
the measurable conditions at motor vehicle crashes (MVC).
This will be accomplished by gathering data at three
trauma centers. Data will be gathered on all patients
transported by EMS for an injury related to an MVC,
motorcycle crash, fall, pedestrian or bicycle struck.
This will include patients of all severity levels.
Patient enrollers will interview EMS to determine which
of the criteria the patient met. The patient will then
be followed to determine their outcome. Two measures
will be used as a proxy for trauma center need: Injury
Severity Score greater than 15; and, (2) a composite
measure of admission to the intensive care unit,
emergent non-orthopedic surgery, and death. The
sensitivity and specificity of the current conditions
under the mechanism of injury component of the criteria
will be calculated. In addition, for the measurable
conditions Receiver Operator Curves will be generated to
determine the ideal cut point. Finally, professional
crash investigators will be sent to a sub-set of MVC to
determine if EMS estimates are accurate. The public will
benefit from this research because we will have
validated the individual conditions under the mechanism
of injury component of the Field Triage Criteria. This
information will advance clinical practice by providing
the scientific evidence needed to modify the current
Field Triage Criteria. This modification would minimize
under and over triage of injured patients so as to
decrease morbidity and mortality and allow both the EMS
and trauma system to be more efficient for the treatment
of all patients.
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Frederick P. Rivara
Harborview Injury Prevention & Research Center
325 9th Ave.
Box 359960
Seattle, WA 98104
E-mail: fpr@u.washington.ed
Project Title: Disability from Pediatric Traumatic Brain Injury
Project Period: 9/1/2006 – 8/31/2011
Importance: Population based studies have estimated the incidence of TBI but have not provided population based estimates of subsequent disability. This population-based information is important for the appropriate planning and delivery of services to children disabled by TBI.
Objectives: (1) Determine the incidence of mild, moderate, and severe TBI in children and adolescents 0-18 years of age; (2) Determine the disability from different severities of TBI in children of different age groups; (3) Determine how this disability changes overtime after injury; and (4) Identify risk and protective factors for disability from TBI.
Study Design: In this project, we will conduct a population-based surveillance of children and adolescents with TBI. From this surveillance, we will identify a sample of pediatric patients with TBI who will be recruited and enrolled in the study. This sample will be stratified by severity and age to allow adequate numbers of individuals at each severity level and each age group for study. Initial and baseline measurements will be obtained, and patients will be followed overtime to determine outcomes from TBI.
Setting: Subjects will be identified in Emergency Departments, Hospitals and Medical Examiners in King County, Washington, and Philadelphia County, Pennsylvania.
Participants: 1000 patients 0-18 years of age with mild, moderate or severe TBI.
Outcome Measures: We will examine patient and family disability pre-injury and at 3, 12, 24, and 36 months post-TBl. This will include quality of life, social, emotional, behavioral and academic disability inpatients and family functioning and parenting stress.
Implications: This study will address many of these unanswered questions surrounding pediatric TBI. It will provide population-based rates of the incidence and disability from TBI, including mild, moderate and severe based on medical record and interview data. It will follow patients and their families for three years after injury, examining the degree to which recovery plateaus in the months following TBI. It will examine factors which interact with the injury to produce disability, be they positive or negative influences on outcomes. The Study team represents an interdisciplinary group of very
experienced investigators to carry out a rigorous study to provide information to inform future research, care and policy.
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Charles DiMaggio, PhD, MPH
Director, Program for Healthcare System Preparedness
Columbia University, New York
722 West 168 Street, Room 1040
New York, NY 10032
Phone: 212-342-4131
Fax: 212-342-5160
Email: cjd11@columbia.edu
Project Title: Behavioral Health Effects of September 11, 2001
Project Period: 9/30/04–9/29/07
Description: The goal of this project is to identify opportunities
for primary and secondary prevention of terrorist- and disaster-related
behavioral health disturbances by assessing the effects of the September
11, 2001, terrorist attacks on the health of New York City's
communities. The study will determine whether there was an increase
among vulnerable populations in emergency department and outpatient
visits for stress-related conditions. The study will also examine
whether such increases are associated with an adverse affect on the
overall health of the community.
The research plan includes the following components:
- Documenting past patterns of post-disaster
medical visits in developed nations;
- Conducting an epidemiologic study of demographic,
clinical, diagnostic, and socioeconomic variables associated with
outpatient and emergency department use;
- Creating a geographic information system to
compare observed versus expected base population rates of outpatient
and emergency department visits for stress-related conditions;
- Testing the hypothesis that the post-impact
period is an independent risk factor for the occurrence of
anxiety-related outpatient and emergency visits among vulnerable
populations by using epidemiologic surveillance-related statistical
tools to calculate correlations and regression analyses; and
- Identifying spatial or temporal associations
between the events of 2001 and deleterious effects on overall
community health, as indexed by public, medical, social, and mental
health indicators (such as the occurrence of intimate partner
violence).
Research findings will aid practitioners in responding
to post-disaster behavioral health needs, public health agencies in
establishing baselines for surveillance and planning for surge capacity
demands, and emergency management policy makers in educating and
mobilizing their communities.
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Judith Holt, PhD
Utah State University
Center for Persons with Disabilities
6800 Old Main Hill
Logan, Utah 84322-6800
Phone: 435-797-7157
Fax: 435-797-7219
Email: Judith@cpd2.usu.edu
Project Title: Bottom-up Modeling of Evacuation Methodologies
Project Period: 9/30/04–9/29/07
Description: The purpose of this research project is to improve
protection of the workforce from urgent nonoccupational infectious,
environmental, or terrorist threats by identifying effective methods for
evacuating individuals, specifically those with disabilities, from
buildings and other settings in response to such threats. To accomplish
this objective, an innovative and cost-effective methodology,
agent-based modeling, will be developed for application by a unique
interdisciplinary research collaborative. This approach will be used to
examine the effect of evacuation methodologies on the dynamics of mass
pedestrian flows (MPFs) during health-safety events in the built
environment. It will also be used to assess the effectiveness of
evacuation methodologies when applied to individuals with disabilities.
The effectiveness of evacuation methodologies during health-safety
events has not been adequately studied due to the difficulty and expense
of designing valid studies with high potential for application to
diverse physical settings and contexts. Adequate provision for the safe
evacuation of individuals with disabilities adds layers of complexity to
an already-daunting task. Agent-based modeling is a powerful technology
with enormous promise for improving evacuation methodologies used in
health-safety events. Research findings will contribute greatly to the
current body of knowledge by providing a better understanding of
emergent population behaviors and MPFs resulting from evacuation
methodologies, the effects of such methodologies on the emergency egress
of individuals with disabilities, and the evaluation of current
built-environment health- and safety-event evacuation practices. By
addressing critical and fundamental gaps in knowledge, this research
will ultimately improve the effectiveness of planning for the emergency
egress of individuals of all abilities from the built environment during
health-safety events and will decrease evacuation-related injuries and
deaths in the workforce.
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Research Cooperative Agreements
Pamela Diamond, Ph.D.
University of Texas at Houston
School of Public Health
7000 Fannin, suite 2614
Houston TX 77030
Phone: 713-500-9979
Fax: 713-500-9602
pdiamond@sph.uth.tmc.edu
Barbara A. Gabella
Colorado Dept of Public Health & Environment
PSD-IE-A4
4300 Cherry Creek Dr., South
Denver, CO 80246-1530
Phone: (303) 692-3003
Fax: (303) 691-7901
Barbara.Gabella@state.co.us
Project Title: Studies to Determine the Prevalence of a History
of Traumatic Brain Injury (TBI) in an Institutionalized Population
Project Period: 09/01/04- 08/31/05
Description: The purpose of this program is to fund a
cooperative agreement to conduct pilot studies to investigate
methods for determining the prevalence of a history of traumatic
brain injury (TBI) in an institutionalized population. For purposes
of this project, “institutionalized” refers to persons who are
either incarcerated or residing in a nursing home.
Anecdotal reports suggest that a very large proportion of the prison
population may have experienced one or more TBIs, with many of them
occurring prior to incarceration. The cognitive deficits that can
result from traumatic brain injuries often are not visible, and
behavioral and emotional problems associated with TBI may be
attributed to other causes. Thus, prisoners with TBI as well as
prison officials may not be aware of the signs, symptoms, and
long-term problems resulting from TBI, and therefore may not seek or
provide appropriate treatment or other interventions. Better methods
for identifying incarcerated persons with a history of TBI and
related problems could lead to improved management of TBI in this
population.
An estimated 20 to 30 percent of persons hospitalized with moderate
to severe TBI are discharged to nursing homes, including those for
long-term care. Not all of the persons with TBI who are discharged
to nursing homes are elderly, but little is known about the age
distribution and other characteristics of this population. Of note,
research on a small number of persons with TBI residing in long-term
nursing facilities found that, with the proper rehabilitation, they
recovered sufficient function to return home or live in a supported
community living environment. Better information on the number and
characteristics of persons with TBI living in nursing homes,
including their functional levels, would inform the development of
policies to ensure that they receive appropriate rehabilitation
services that can help them return to the community.
Two projects, one at the University of Texas at Houston, and one at
the Colorado Department of Public Health and the Environment, are
currently funded from this Program Announcement.
University of Texas at Houston
As prison populations across the country grow, there is a need for
greater understanding of the health needs of this diverse
population. Prison inmates often come from poverty situations where
health care options are limited. They are likely to have abused both
legal and illegal substances, and they engage in activities that put
them at risk of both unintentional and intentional injury. These
factors combine to place this population at high risk of
experiencing Traumatic Brain Injury (TBI), which may be medically
under-treated and exacerbated by subsequent substance use. TBI often
results in behavioral symptoms, which, if untreated, can lead to
difficulties in adjustment to prison life and may make successful
reintegration into the community upon release less likely. There is
little research available on the prevalence of TBI history among
prison inmates. This study will begin to address a gap in the
literature by developing and validating a brief interview instrument
to assess history of TBI among prison inmates.
The availability of a reliable, valid and efficient assessment
instrument will make it possible in the future for prison services
personnel to screen for head injury as a part of standard
operations, thus facilitating earlier identification of TBI in this
population and allowing for more appropriated assignment to
treatment and rehabilitation during incarceration. This research
builds upon an ongoing study of the prevalence of mental heath
problems among the federal prison population (The Mental Health
Prevalence Study: MHPS) that has collected both self-report and
archival data from over 2000 inmates from 13 prison units across the
country.
The specific aims of the study are: 1) To develop an efficient
interview based instrument for assessing a history of TBI in a
civilian prison population, and 2) To develop a feasible
plan/proposal for assessing the prevalence of TBI among the federal
prison inmate population using the validated instrument and related
measures of cognitive, behavioral and psychological function.
Colorado Department of Health and Environment
The federal Centers for Medicare and Medicaid Services (CMS)
requires all nursing homes utilizing Medicare or Medicaid
reimbursement to assess their residents at admission, quarterly,
annually, and whenever there is a significant change in the
resident’s status. CMS requires nursing homes to use the
standardized Minimum Data Set (MDS) for reporting. This assessment
tool provides comprehensive information on the resident, including
cognitive and physical function, activities of daily living, disease
and injury diagnoses, discharge potential and psychosocial status.
Though several items on the MDS have been validated, history of
having had a traumatic brain injury (TBI) has not.
Jointly, two divisions at the Colorado state health department
propose validating the TBI idem and TBI-related ICD-9 codes on the
MDS. This validation could streamline the eligibility process for
the new Colorado TBI trust fund, potentially leading to additional
services being available to nursing home residents with TBI.
The Colorado pilot study will have similar important implications
for nursing home residents in other states, since and estimated 95%
of the nursing homes in the U.S. must use the MDS and since 14 other
states have TBI trust funds that pay for services. If the aims of
the research prove successful, other states could partner with CMS
and replicate the methods to validate the TBI diagnosis for their
MDS and determine the prevalence of TBI in nursing homes in their
own states.
The specific aims of this project are: 1) to validate the
diagnosis of TBI on the Resident Assessment Instrument's Minimum
Data Set (MDS) Tool, a federally-mandated data system used by
all nursing homes in the United States; 2) to identify cases of
TBI missed by the MDS; 3) to use the MDS, if valid, to determine
the prevalence of TBI in nursing home residents in Colorado; and
4) to describe functional status as measured by the activities
of daily living and demographic characteristics of nursing home
residents with TBI in Colorado. Investigators will seek approval
from the Centers for Medicare and Medicaid Services (CMS) to use
part of the MDS data for this project, by completing the CMS
process to obtain a data use agreement. For a random sample of
nursing home residents with an ICD-9-CM code for TBI or a
diagnosis of TBI on the MDS, investigators will verify the TBI
using three sources of medical information: medical records at
the nursing homes, inpatient medical records, and data from the
Colorado TBI surveillance system. If a medical diagnosis of TBI
or the clinical criteria for TBI as defined by CDC is documented
in any of the three sources, then the TBI on the MDS will be
considered accurate. To quantify the accuracy of TBI on the MDS
for the sample of residents, the investigators will calculate
the positive predictive value. Under the provisions of a data
use agreement with CMS, investigators will analyze the
demographic characteristics and activities of daily living for
residents with TBI.
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Gerard Gioia PhD
Children’s Research Institute
111 Michigan Ave
Washington, DC 20010
Phone: 202-745-5006
Fax: 202-745-5586
E-mail: ggioia@cnmc.org
Project Title: Outcome Measurement of MTBI Among Children and
Adolescents
Project Period: 9/30/03-9/29/07
Description: The Children’s Research Institute proposes to
develop and validate a test battery for measuring the neurocognitive
and behavioral outcomes of children ages 6-18 who sustain a mild
traumatic brain injury (MTBI).
Researchers will first adapt and pilot the test battery on 90
children (60 healthy children and 30 with cognitive conditions
including MTBI). Second, they will collect normative data on 800
children without documented disabilities and 120 children with
developmental disabilities. Third, they will test the computerized
battery on 40 children who sustain an MTBI and present to the
emergency department. Finally, researchers will implement the test
battery in three different settings: an urban hospital emergency
room, a rural hospital emergency room, and a sports recreation
program.
Goals of this research are to develop a computerized test battery
for MTBI with ImPACT, the BRIEF, and N-back test; to develop
normative data for this battery; to examine the validity of the test
battery; and to implement the battery in several emergency
departments and sports/recreational settings.
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Marilyn J. Heine
Pennsylvania Chapter of American College of Emergency Physicians
777 East Park Drive
PO Box 8820
NEED CITY, STATE, AND ZIP CODE
Email: MHeine@paacep.org
Project Title: The Future of Emergency Medicine in Pennsylvania
Project Period: 8/01/05–7/31/06
Description: This program conducted by the Pennsylvania Chapter of the American College of Emergency Physicians (PaACEP) will study the role of Pennsylvania’s emergency physicians (EPs) as safety net providers. This program addresses the performance goal of the National Center for Injury Prevention and Control to increase the capacity of injury prevention and control programs, and the prevention of injuries and violence, a “Healthy People 2010” focus area; and supports the CDC research goal of enhancing health. The program’s four aims are to: 1) identify and describe injury prevention and
control programs used in Pennsylvania’s Emergency Departments (PaEDs), describe measurable outcomes of success and barriers to implementation, and suggest methods to overcome these barriers; 2) develop, implement in a PaED, and measure the outcomes of a program aimed at reducing youth violence, domestic abuse, or preventable childhood injuries; 3) describe the current workforce of Pennsylvania’s EPs and project future workforce trends and needs; and
4) describe information and data management systems aimed at improving patient safety used in PaEDs and measure their effectiveness and identify areas for improvement.
PaACEP will request proposals from academic centers and other institutions in Pennsylvania to answer these four objectives. PaACEP will review these proposals, selecting recipients, monitor the activities of the recipients, and will determine a timeline for project completion. PaACEP will review each completed project, independently analyzing study data when applicable, reviewing the investigator’s conclusions, and approving the completed project. PaACEP will prepare interim progress reports, analyzing each of the final reports for completed objective, and will prepare final financial and
performance reports. This program is relevant to the public health of the citizens of Pennsylvania because of the vital role that emergency physicians play in the health care safety net. Continued access to safe, high quality EPs who can provide excellent care while enhancing injury prevention will help to improve the health of Pennsylvania’s citizens.
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