Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 1. Overview Information

Participating Organization(s)
/ Centers for Disease Control and Prevention (CDC)
Components of Participating Organizations
/ National Center for Injury Prevention and Control (NCIPC)
Funding Opportunity Title
/ Field Triage of Traumatic Brain Injury (TBI) in Older Adults Taking Anticoagulants or Platelet Inhibitors
Mechanism of Support
/ U01 Research Project Cooperative Agreements
Announcement Type
/ New
Funding Opportunity Announcement (FOA) Number
/ RFA-CE-12-005
Catalog of Federal Domestics Assistance (CFDA) Number(s)
/ 93.136, Injury Prevention and Control Research and State and Community Based Programs
Category of Funding Activity
/ Health
FOA Purpose
/ The purpose of this research is to design and evaluate strategies for the appropriate triage of older adults with potential traumatic brain injury who are taking anticoagulants and platelet inhibitors. The first stage will be to assess the burden (e.g., death, disability, hospitalization, required procedures) of TBI among older adults taking anticoagulants and platelet inhibitors. The next stage will be the development of tools to improve triage of these high risk patients by an EMT (emergency medical technician), including an appropriate medication history and performing novel field-based neurologic screening, beyond the current Glasgow Coma Score (GCS) standard.The overall goal is to ensure that these potentially high risk patients (taking anticoagulants/platelet inhibitors and screening positive during the field-based neurologic examination) who are suspected of a TBI are taken to a center with 24 hour neurosurgical and neurologic intensive care capability (e.g. a Level I/II Trauma Center).This research addresses the “Healthy People 2020” focus area(s) of Injury and Violence Prevention.

Key Dates

Publication Date
/ To receive notification of any changes to RFA-CE-12-005,
return to the synopsis page of this announcement at www.grants.gov and click on the “Send Me Change Notification Emails” link An email address is needed for this service.
Letter of Intent Due Date
/ March 30, 2012
Application Due Date
/ April 30, 2012, by 5:00 PM U.S. Eastern Time.
On-time submission requires that electronic applications be error-free and made available to CDC for processing from eRA Commons on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov/eRA Commons no later than 5:00 PM U.S. Eastern Time. Note: HHS/CDC grant submission procedures do not provide a period of time beyond the application due date to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e., error correction window).
Scientific Merit Review
/ May 2012
Secondary Review
/ May – June, 2012
Start Date
/ September 2012

Expiration Date

/ May 1, 2012

Due Dates for E.O. 12372

/ Executive Order 12372 does not apply to this program.

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Note: The Research Strategy component of the Research Plan is limited to 25 pages.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348

Part 2. Full Text

Section I. Funding Opportunity Description

Statutory Authority

This program is authorized under Section 393A [42 U.S.C. Section 280b-1b] of the Public Health Service Act, as amended; and Public Law 104–166 Prevention of Traumatic Brain Injury.

Background

Traumatic brain injury (TBI) among older adults represents an increasing proportion of trauma seen by hospitals, largely due to same-level falls (1), a major risk factor for intracranial injury and in-hospital mortality (2, 3). Anticoagulants and platelet inhibitors, most notably warfarin (Coumadin), but also aspirin (5), clopidogrel (6), and low-molecular-weight heparin, are associated with intracranial hemorrhage resulting in longer hospitalizations, intensive care unit stays, post-traumatic disability, and death. These medications are frequently taken to prevent embolic strokes in middle-aged and older adults with cardiac arrhythmias or artificial valves, and also to prevent embolization of cardiac stents and treatment for deep venous thrombosis (DVT), pulmonary emboli (PE), or other coagulation disorders. Furthermore, older adults are less likely to be taken to trauma centers than their younger counterparts for similar injuries (7, 8). Anticoagulated TBI patients at risk for intracranial hemorrhage require a rapid head CT scan and reversal of anticoagulation if the CT scan is positive. Intracranial hemorrhage may also require emergent surgical intervention, in addition to observation in an intensive care unit. Ensuring these patients are adequately triaged to a capable facility, led to the addition of “patients with head injury are at high risk for rapid deterioration” in the Anticoagulants and Bleeding Disorders section, of the 2012 Guidelines for Field Triage of Injured Patients (9,10).

Purpose

The purpose of this research is to design and evaluate strategies for the appropriate triage of older adults with potential traumatic brain injury who are taking anticoagulants and platelet inhibitors. The first stage will be to assess the burden (e.g., death, disability, hospitalization, required procedures) of TBI among older adults taking anticoagulants and platelet inhibitors. The next stage will be the development of tools to improve triage of these high risk patients by an EMT (emergency medical technician), including an appropriate medication history and performing novel field-based neurologic screening, beyond the current Glasgow Coma Score (GCS) standard.The overall goal is to ensure that these potentially high risk patients (taking anticoagulants/platelet inhibitors and screening positive during the field-based neurologic examination) who are suspected of a TBI are taken to a center with 24 hour neurosurgical and neurologic intensive care capability (e.g. a Level I/II Trauma Center).This research addresses the “Healthy People 2020” focus area(s) of Injury and Violence Prevention.

Research Objectives

This research will evaluate strategies for the appropriate triage of older adults taking anticoagulants after a trauma to the head in a statistically adequate and representative sample of individuals with TBI (consistent with the CDC definition of TBI; page 21 of the 1999 Traumatic Brain Injury. A Report to Congress, located at: http://www.cdc.gov/traumaticbraininjury/factsheets_reports.html) who were admitted to United States emergency departments or hospital wards (including trauma centers). To address these issues, this announcement solicits research projects to achieve these goals during the 3-year project period.

Primary Objectives

·  Evaluate the current prehospital triage of TBI in older adults (>55 years) taking anticoagulants or platelet inhibitors in a large county-wide or city-wide sample, utilizing multiple EMS agencies with large call volumes serving a large population of older adults. The county or city should have a Level I or II trauma center as well as non-trauma centers.

o  Describe the triage algorithm used by EMTs to identify patients with TBI

o  Describe standardized questions asked by EMTs to identify patients taking anticoagulants or platelet inhibitors

o  Link prehospital EMS data to emergency department (ED) and inpatient records to determine patient outcomes (death and disability) based on triage destination and level of anticoagulation/platelet inhibitor use. Linkage should allow the identification of patients seen and then transferred to other facilities, even if outside of the county or city. This is essential to prevent the duplication of patients seen at one or more facilities for the same TBI and determine the ultimate outcome based on the initial field triage decision.

·  Evaluate novel triage algorithms for field triage of TBI in older adults (>55 years) taking anticoagulants or platelet inhibitors. The algorithm should include testing various neurologic scales in older adults with applicability in the prehospital environment that could better identify high risk TBI, such as AVPU, simplified motor score (SMS), simplified verbal score (SVS), pupil size and reactivity, and GCS-motor component. The algorithm should also test the most appropriate methods for obtaining anticoagulant and platelet inhibitor medication histories from patients, including: direct questioning, medication bracelets or cards, and discussion with family.

·  On the basis of these results, provide recommendations for the most effective algorithm for field triage of TBI in older adults (>55 years) taking anticoagulants or platelet inhibitors.

Contributing factors to be evaluated

·  Demonstrate the current clinical management and outcomes of TBI among anticoagulated older adult patients (age >55 years) seen in Level I-IV trauma centers and non-trauma centers.

o  Describe the degree of anticoagulation: post-injury anticoagulation level measured prior to reversal therapy in the ED (e.g., international normalized ratio [INR] for patients on coumadin, PTT [partial thromboplastin time] for patients on heparin, and Anti-factor Xa for patients on enoxaparin).

o  Describe the use and timing of reversal agents (e.g., Vitamin K and FFP for Coumadin and protamine for enoxaparin and heparin), neurosurgical interventions (e.g., craniectomy), and neurologic monitoring (e.g., intracranial pressure monitoring and elevating the head of the bed).

·  Analyze the interfacility transfer of these patients after being diagnosed with an intracranial hemorrhage, paying particular attention to their treatment in the original facility and during ambulance transport.

·  Assess the compliance with the Brain Trauma Foundation (BTF) Guidelines for the Pre-hospital Management of Severe Traumatic Brain Injury during ambulance transport and compliance with the BTF Guidelines for the Management of Severe Traumatic Brain Injury by trauma center level and among non-trauma centers (11, 12).

https://www.braintrauma.org/pdf/Prehospital_Guidelines_2nd_Edition.pdf

References:

1. Chisholm KM, Harruff RC. Elderly deaths due to ground-level falls. Am J Forensic Med Pathol 2010; 31(4):350-4.

2. Spaniolas K, Cheng JD, Gestring ML, Sangosanya A, Stassen NA, Bankey PE. Ground level falls are associated with significant mortality in elderly patients. J Trauma 2010; 69(4):821-5.

3. Sarani B, Temple-Lykens B, Kim P, Sonnad S, Bergey M, Pascual JL, Sims C, Schwab CW, Reilly P. Factors associated with mortality and brain injury after falls from the standing position. J Trauma 2009 Nov; 67(5):954-8.

4. Howard JL 2nd, Cipolle MD, Horvat SA, Sabella VM, Reed JF 3rd, Fulda G, et al. Preinjury warfarin worsens outcome in elderly patients who fall from standing. J Trauma 2009; 66(6):1518-22; discussion 1523-4.

5. Tauber M, Koller H, Moroder P, Hitzl W, Resch H. Secondary intracranial hemorrhage after mild head injury in patients with low-dose acetylsalicylate acid prophylaxis. J Trauma 2009; 67(3):521-5; discussion 525.

6. Wong DK, Lurie F, Wong LL. The effects of clopidogrel on elderly traumatic brain injured patients. J Trauma 2008; 65(6):1303-8.

7. Chang DC, Bass RR, Cornwell EE, Mackenzie EJ. Undertriage of elderly trauma patients to state-designated trauma centers. Arch Surg 2008; 143(8):776-81; discussion 782.

8. Lehmann R, Beekley A, Casey L, Salim A, Martin M. The impact of advanced age on trauma triage decisions and outcomes: a statewide analysis. Am J Surg 2009; 197(5):571- 4.

9. Sasser SM, Hunt RC, Sullivent EE, et al; National Expert Panel on Field Triage, Centers for Disease Control and Prevention (CDC). Guidelines for field triage of injured patients. Recommendations of the National Expert Panel on Field Triage. MMWR Recomm Rep. 2009 Jan 23; 58(RR-1):1-35.

10. Sasser SM, Hunt RC, Faul M, et al; Guidelines for Field Triage of Injured Patients Recommendations of the National Expert Panel on Field Triage, 2011 (CDC, in press).

11. Brain Trauma Foundation and American Association of Neurological Surgeons. Guidelines for Prehospital Management of Traumatic Brain Injury. [BTF Web site]. Available at: https://www.braintrauma.org/coma-guidelines/. Accessed September 13, 2011.

12. Brain Trauma Foundation and American Association of Neurological Surgeons. Management and prognosis of severe traumatic brain injury. [BTF Web site]. Available at: https://www.braintrauma.org/coma-guidelines/. Accessed September 13, 2011.

Section II. Award Information

Funding Instrument

/ Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

/ New
The NIH OER Glossary (http://grants.nih.gov/grants/glossary.htm)
and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

/ NCIPC intends to commit approximately $500,000 in FY2012 to fund up to 2 awards.
Awards issued under this FOA are contingent on the availability of funds and submission of a sufficient number of meritorious applications.

Ceiling and Floor of Individual Award Range

/ The maximum award amount will be $250,000 for the first 12-month budget period. The maximum total project funding amount includes direct and indirect costs.
There is no minimum award

Project Period Length

/ 3 years
Throughout the project period, CDC's commitment to continuation of awards will be conditional on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the Federal government.

HHS/CDC grants policies as described in the HHS Grants Policy Statement (http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html) will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions:

·  Public/State Controlled Institutions of Higher Education

·  Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for CDC support as Public or Private Institutions of Higher Education:

·  Hispanic-serving Institutions

·  Historically Black Colleges and Universities (HBCUs)

·  Tribally Controlled Colleges and Universities (TCCUs)

·  Alaska Native and Native Hawaiian Serving Institutions