Foa_Content_of_RFA-CE-22-007 rev.pdf

Centers for Disease Control and Prevention

NATIONAL CENTER FOR INJURY PREVENTION AND CONTROL

Reduce Health Disparities and Improve Traumatic Brain Injury (TBI) Related Outcomes Through the Implementation of CDC’s Pediatric Mild TBI Guideline

RFA-CE-22-007

02/22/2022

Table of Contents 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

Overview Participating Organization(s) Centers for Disease Control and Prevention Components of Participating Organizations Components of Participating Organizations:

National Center for Injury Prevention and Control Notice of Funding Opportunity (NOFO) Title Reduce Health Disparities and Improve Traumatic Brain Injury (TBI) Related Outcomes Through the Implementation of CDC’s Pediatric Mild TBI Guideline Activity Code Applications in response to this Notice of Funding Opportunity (NOFO) will be funded using the U01 activity code for a research cooperative agreement

Notice of Funding Opportunity Type New Agency Notice of Funding Opportunity Number

RFA-CE-22-007

Assistance Listings Number(s) 93.136 Category of Funding Activity HL - Health NOFO Purpose The Centers for Disease Control and Prevention (CDC) National Center for Injury Prevention and Control (NCIPC) is soliciting investigator-initiated research proposals for an implementation study to promote the adoption and integration of the “Centers for Disease Control and Prevention Guideline on the Diagnosis and Management of Mild Traumatic Brain Injury Among Children,” hereinafter referred to as CDC’s Pediatric mTBI Guideline, in a large health care system to: a) improve mild traumatic brain injury (mTBI) outcomes in children and adolescents, and b) reduce disparities in TBI-related care and outcomes.

Applicants are expected to focus on the following research questions:

1. What type of disparities in mTBI-related processes and outcomes currently exist at baseline in a healthcare system(s) prior to initiation of an intervention to systematically implement CDC’s Pediatric mTBI Guideline?

2. Does an intervention aimed at systematically implementing CDC’s Pediatric mTBI Guideline in a healthcare system(s) result in a reduction of health disparities, relative to baseline, vis a vis improved process and health outcomes? Applicants are encouraged to supplement the mTBI Guideline implementation with added outreach efforts to children experiencing disadvantage, and implementation strategies that address TBI-related care and health disparities identified within the health system.

For the purposes of this NOFO, mTBI-related processes and outcomes include those related to the identification and treatment of an mTBI (e.g., discharge instructions, counseling regarding return to school and return to play, communication with the school about symptoms, recovery, accommodations) as well as health outcomes. An indicator of care might be length of time between injury and diagnosis and treatment of an mTBI or the recovery trajectory of an mTBI.

Disparities (health outcomes seen to a greater or lesser extent between populations) may be related to various factors of the injured child or adolescent, their family or neighborhood, or community, such as race, gender, sexual identity, disability, socioeconomic conditions, or geographic location.

The purpose of Amendment 1 to NOFO RFA-CE-22-007 is to:

Update the NOFO Description shown on the Grants.gov Synopsis page (https://www.grants.gov/web/grants/view-opportunity.html?oppId=336420) to reflect the Purpose section of the NOFO.

Update Section I. Funding Opportunity Description, 1 Background and Purpose, Minority Serving Institutions, to include the title of this section: Minority Serving Institutions.

Update Section I. Funding Opportunity Description, 2 Approach, to describe Responsiveness Criteria related to the primary goals and objectives of the proposed research and prevention approach:

The first paragraph of the Specific Aims section of the application must clearly describe the primary goals and objectives of the proposed research and the prevention approach that will be evaluated. Applications that do not clearly propose to demonstrate the effectiveness of an intervention informed by CDC’s Pediatric mTBI Guideline, to: a) improve mild traumatic brain injury (mTBI) outcomes in children and adolescents, and b) reduce disparities in TBI-related care and outcomes, as evidenced by the Specific Aims section of the application's research plan, will be considered nonresponsive and will not be forwarded for peer review.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=336420

Applications must be responsive to NOFO RFA-CE-22-007 in order to be forwarded for peer review. Additional responsiveness criteria are listed in Section III. Eligibility Information 5. Responsiveness of this NOFO. It is the applicant’s responsibility to ensure that the submitted research proposal meets all responsiveness criteria listed in Section III. Eligibility Information 5. Responsiveness.

Update Section III. Eligibility Information, 5 Responsiveness, to clarify the responsiveness criteria for the following sections:

o Research Objectives:

Corrected the spelling of Objectives, it now reads “Research Objectives” To the criteria, added: “as evidenced by the Specific Aims section of the application”.

o Researcher Expertise:

Clarified the location for including researcher expertise, it now reads “SF-

424 Biographical Sketch”

Update Section V. Application Review Information, 4 Review and Selection Process, to include the section of the application to be reviewed in consideration of each criteria. The updated criteria now read:

o Consideration for meritorious applications that have already identified TBI-related disparities in their implementation facilities and have described how they plan to focus on those disparities through the proposed intervention, as evidenced by the Research Strategy section of the application's research plan.

o Consideration for meritorious applications that propose to extend Return to Play and Return to Learn protocols beyond guidance provided in discharge instructions and incorporate continued engagement between the health and education systems and sports programs, as evidenced by the Research Strategy section of the application's research plan.

o Consideration for meritorious applications that include health systems with integrated emergency departments, examine the intervention in multiple clinical settings (primary care, ED, specialty clinics, urgent care), and allow for multi-site investigations, as evidenced by the Research Strategy section of the application's research plan.

o Consideration for meritorious applications that propose to address inequities in TBI diagnosis and management, including studies that inform or evaluate strategies that address social and structural conditions contributing to these inequities, as evidenced by the Research Strategy section of the application's research plan.

Key Dates Publication Date:

To receive notification of any changes to RFA-CE-22-007, 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:

https://www.grants.gov/

01/10/2022 January 10, 2022

Application Due Date:

02/22/2022 Applications are due on the listed application due date at 5:00PM EST. Please carefully review and follow the instructions in Section IV. Application and Submission Information 9.

Submission Dates and Times in order to ensure timely receipt of your application.

On-time submission requires that electronic applications be error-free and made available to CDC for processing from the NIH eRA system on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov no later than 5:00 PM U.S. Eastern Time.

Applicants will use a system or platform to submit their applications through Grants.gov and eRA Commons to CDC. ASSIST, an institutional system to system (S2S) solution, or Grants.gov Workspace are options. ASSIST is a commonly used platform because it provides a validation of all requirements prior to submission and prevents errors.

For more information on accessing or using ASSIST, you can refer to the ASSIST Online Help Site at: https://era.nih.gov/erahelp/assist. Additional support is available from the NIH eRA Service desk via http://grants.nih.gov/support/index.html.

E-mail: commons@od.nih.gov Phone: 301-402-7469 or (toll-free) 1-866-504-9552.

Hours: Monday - Friday, 7 a.m. to 8 p.m. Eastern Time, excluding Federal holidays.

Note: HHS/CDC grant submission procedures do not provide a grace period beyond the application due date time 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:

06/08/2022 June 8, 2022; estimated

Secondary Review:

07/28/2022 July 28, 2022; estimated

Estimated Start Date:

09/30/2022 September 30, 2022

Expiration Date:

04/05/2022 Required Application Instructions It is critical that applicants follow the instructions in the How to Apply - Application Guide except where instructed to do otherwise in this NOFO. Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-http://grants.nih.gov/support/index.html mailto:commons@od.nih.gov https://grants.nih.gov/grants/how-to-apply-application-guide.html 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 20 pages.

Page Limitations: Pages that exceed the page limits described in this NOFO will be removed and not forwarded for peer review, potentially affecting an application's score.

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

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

Executive Summary Purpose:

The Centers for Disease Control and Prevention (CDC) National Center for Injury Prevention and Control (NCIPC) is soliciting investigator-initiated research proposals for an implementation study to promote the adoption and integration of the “Centers for Disease Control and Prevention Guideline on the Diagnosis and Management of Mild Traumatic Brain Injury Among Children,” hereinafter referred to as CDC’s Pediatric mTBI Guideline, in a large health care system to: a) improve mild traumatic brain injury (mTBI) outcomes in children and adolescents, and b) reduce disparities in TBI-related care and outcomes.

Applicants are expected to focus on the following research questions:

1. What type of disparities in mTBI-related processes and outcomes currently exist at baseline in a healthcare system(s) prior to initiation of an intervention to systematically implement CDC’s Pediatric mTBI Guideline?

2. Does an intervention aimed at systematically implementing CDC’s Pediatric mTBI Guideline in a healthcare system(s) result in a reduction of health disparities, relative to baseline, vis a vis improved process and health outcomes? Applicants are encouraged to supplement the mTBI Guideline implementation with added outreach efforts to children return to school and return to play, communication with the school about symptoms, recovery, accommodations) as well as health outcomes. An indicator of care might be length of time between injury and diagnosis and treatment of an mTBI or the recovery trajectory of an mTBI.

Disparities (health outcomes seen to a greater or lesser extent between populations) may be related to various factors of the injured child or adolescent, their family or neighborhood, or community, such as race, gender, sexual identity, disability, socioeconomic conditions, or geographic location.

Mechanism of Support: The funding mechanism for this Notice of Funding Opportunity (NOFO) will be a research cooperative agreement (U01).

Funds Available and Anticipated Number of Awards: CDC/NCIPC intends to commit up to $550,000 in FY 2022 to fund up to one (1) application. Awards issued under this NOFO are contingent upon availability of funds and a sufficient number of meritorious applications.

Because the nature and scope of the proposed research will vary from application to application, it is also anticipated that the size and duration of each award may also vary. The total amount awarded and the number of awards will depend upon the number, quality, duration and cost of the applications received.

Budget and Project Period:

The maximum award amount will be $550,000 per award for the first 12 month budget period.

This includes both direct and indirect costs. An applicant may request a project period of up to four years. The maximum total project funding amount is $2,200,000 (including both direct and indirect costs) over the expected project period length, with a maximum of $550,000 per award per year. The project period for this award is expected to run from 9/30/2022 to 9/29/2026.

Application Research Strategy Length Page limits for the Research Strategy are clearly specified in Section IV. Application and Submission Information of this announcement.

Eligible Institutions/Organizations Institutions/organizations listed in Section III. Eligibility Information 1. Eligible Applicants are eligible to apply.

Eligible Project Directors/Principal Investigators (PDs/PIs) CDC does not make awards to individuals directly. Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply.

Applications in which the contact Eligible PD/PI meets NIH Early Stage Investigator (ESI) status, as verified via the NIH Determination of Investigator Status process, and whose application has a meritorious peer review score, may be considered for prioritization during the second level of review (see Section V. Application Review Information 4. Review and Selection Process). For the contact PD/PI Determination of Investigator Status:

Prior to application submission, PD/PIs are encouraged to verify and/or enter the date of their terminal research degree or the end date of their post-graduate clinical training in their eRA Commons Profile to ensure the correct identification. NIH systems will automatically calculate the status of each investigator and display it within their eRA Commons personal profile. The ESI status of the PD/PIs on any R01 or R01 equivalent application will be flagged at time of submission. Investigators should make sure their status is correctly marked in their profile. If your status is incorrect, please contact the NIH eRA Service Desk.

Number of PDs/PIs https://grants.nih.gov/policy/early-investigators/index.htm https://grants.nih.gov/policy/early-investigators/index.htm#dis https://grants.nih.gov/support/index.html

An application may name more than one PD/PI; their names must appear on the face page of the application. However:

One (1) principal investigator must be designated as the contact PD/PI for all correspondence related to the application.

All PD/PIs must include their eRA Commons Identification in the Credential Field of the Senior/Key Person Profile Component of the SF-424 (R&R) Application Package.

Institutions/organizations proposing multiple PDs/PIs must visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF-424 (R&R) Application Guide.

Number of Applications Eligible applicant organizations may submit more than one application to this NOFO, provided that each application is scientifically distinct. However, applicant institutions can submit only one application with the same contact PD/PI. Only one application per contact PD/PI will be funded under this announcement. If two or more applications from the same contact PD/PI are received for this NOFO, the only application that will be submitted for review will be the last application received based on the document’s time and date stamp in Grants.gov (http://www.grants.gov). The applicant must ensure that duplicate applications are withdrawn prior to the application review date.

Additionally, applicant institutions submitting applications with essentially the same proposed research to two or more CDC/ATSDR NOFOs will not be funded under more than one NOFO.

Application Type. NEW

Special Date(s) A pre-application teleconference call will not be conducted for this NOFO. Applicant questions to clarify information in the text of this NOFO during the NOFO open period are strongly encouraged. Please contact via email the Scientific/Research Contact, Peer Review Contact, or the Financial/Grants Management Contact listed in Section VII. Agency Contacts with questions.

All applicant questions (personal or application related identifying information redacted) received by December 22, 2021 and NCIPC responses to these questions will be included in an amended NOFO that will be published approximately by January 14, 2022. Please see Section VII. Agency Contacts for specific contact information.

Application Materials. See Section IV.1 for application materials.

Section I. Funding Opportunity Description Statutory Authority Section 301 (a) [42 U.S.C. 241(a)] of the Public Health Service Act, and Section 391 (a)[42 U.S.C. 280b(a)] of the Public Health Service Act, as amended.

1. Background and Purpose The National Center for Injury Prevention and Control (NCIPC) recognizes that injury, like disease, is preventable. NCIPC conducts research to develop and evaluate the effectiveness of strategies to prevent various forms of injury and mitigate the public health impacts of injury.1

As attention to concussion and traumatic brain injury (TBI) has grown in recent years, there has been an increase in the number of pediatric patients with concussion (also known as mild TBI, or mTBI) seen in a variety of healthcare settings.2,3 Many providers, however, have insufficient time and training to systematically assess and manage patients with suspected mTBI,4-6 thus limiting adoption of best practices and increasing risk for patient and public health harm. The consequence of missing an mTBI diagnosis includes the failure to recommend appropriate treatment and management; this may contribute to prolongation of symptoms and increased risk of re-injury. Even when an mTBI diagnosis is made, there are inconsistencies in assessment for prognosis, selection of management protocols, and issuance of discharge instructions. Research is needed to identify the best ways to educate providers and support clinical decision making at the point of care to facilitate pediatric mTBI diagnosis and management and improve patient outcomes.

An additional challenge in addressing the public health burden of TBI is that it is not evenly distributed. Disparities in care and outcomes have been shown for children who have experienced a TBI in relation to race/ethnicity, disability status, sex, income, geography, and insurance status. Previous research has documented a greater TBI burden for rural, American Indian/Alaskan Native, African-American, and Hispanic persons. More specifically:

American Indian/Alaska Native children and adults have higher rates of TBI-related hospitalizations and deaths than other racial or ethnic groups.7-10 Inequities contribute to this disparity and lead to higher rates of motor vehicle crashes, substance use, and suicide as well as difficulties in accessing appropriate healthcare.

In addition to differences in rates of TBI, racial and ethnic minority groups, particularly non-Hispanic Black and Hispanic patients, are less likely to receive follow-up care and rehabilitation following a TBI compared to non-Hispanic white patients.11-16 Racial and ethnic minority groups are also more likely to have poor psychosocial, functional, and employment-related outcomes after sustaining a TBI than non-Hispanic white patients.17-

People living in rural areas have a greater risk of dying from a TBI compared to people living in urban areas.22-26 Some reasons for this disparity include:

More time needed to travel to emergency medical care.27

Less access to a Level I trauma center (the highest level of medical care).28

Difficulty getting services, such as specialized TBI care.29,30

Children living in rural areas are more likely to get a TBI and to die as a result of this injury compared to children living in urban areas.26 Children in rural areas may also be more likely to:

Experience delays in getting TBI-related care.30

Be unnecessarily transferred to another hospital for TBI-related care.30

Children with TBI navigate two systems- health systems and school systems. There are challenges, inconsistencies, and gaps in care for children with TBI, particularly for children who are transitioning to school after acute care.31 Methods used to assess factors associated with TBI diagnosis and prognosis – such as the child’s medical history, current school performance, and family circumstances – are variable. Adequate and consistent assessment of such factors is important to help identify children at risk for long-term effects.31 In addition, communication of medical information to parents and school personnel is inconsistent, which contributes to gaps in care31 and potentially poorer health, education, and social outcomes for children.

Data from a large pediatric healthcare system revealed that the majority of children with mTBI are seen in primary care, compared to emergency departments and specialty clinics.2 This finding highlights the need to provide education and clinical decision support in primary care pediatric clinics in particular. Preliminary data suggest that clinical decision support tools can be effectively implemented in primary care practices to assist with diagnosis, management, and treatment of pediatric TBI.32 For example, tools within the electronic health record (EHR) can alert providers to conduct exams not routinely completed, such as vision exams, and encourage discussion of Return to Learn (RTL) and Return to Play (RTP) protocols with parents and children. One study found that implementation of clinical decision support tools in the EHR, combined with systematic clinician training, increased documentation of recommended protocols for children with an mTBI diagnosis.32

While clinician education and EHR-based clinical decision support has been shown to improve process-related outcomes,32 the effect of these efforts have not yet been tested in relation to patient health, education, and social outcomes. Further work is also needed to understand the best mechanisms for enhancing communication among health and school systems and sports organizations to improve implementation of RTL and RTP protocols.

Evidence-based recommendations have emerged to inform the development of protocols that can assist clinicians in the diagnosis and management of pediatric mTBI. For example, NCIPC researchers, in conjunction with the NCIPC Board of Scientific Counselors, established the Pediatric mTBI Guideline workgroup to systematically review the literature and draft recommendations for providers related to the diagnosis and management of pediatric mTBI.

NCIPC researcers used these evidence-based recommendations to develop CDC’s Guideline for Pediatric mTBI Diagnosis and Management.33 Since its publication in November 2018, this Guideline has been used to help educate and support clinicians in implementing best practices for pediatric mTBI diagnosis and management. The development and systematic implementation of evidence-based guidelines hold promise for increasing the use of state of the art care in a uniform way. The provision of uniform, state of the art care is a potential means to reduce health disparities when implemented in places that serve groups experiencing disadvantage.

As previously mentioned, previous research has noted that the public health burden of TBI includes disparities in care and outcomes for children who have experienced a TBI. Disparities have been identified related to race/ethnicity, disability status, sex, income, geography, and insurance status. The social and structural conditions in which people are born, grow, live, work and age can be shaped by the distribution of resources, which is influenced in part by policy.

These social determinants of health (e.g., concentrated poverty, structural racism, high rates of unemployment and community violence, weak social connectedness, limited access to high-quality education and/or affordable, high-quality childcare) contribute to health inequities, including the differences in health status seen across population groups and communities34.

Research is needed to better address disparities in diagnosis and management of pediatric mTBI.

Purpose:

The Centers for Disease Control and Prevention (CDC) National Center for Injury Prevention and Control (NCIPC) is soliciting investigator-initiated research proposals for an implementation study to promote the adoption and integration of the “Centers for Disease Control and Prevention Guideline on the Diagnosis and Management of Mild Traumatic Brain Injury Among Children,” hereinafter referred to as CDC’s Pediatric mTBI Guideline, in a large health care system to: a) improve mild traumatic brain injury (mTBI) outcomes in children and adolescents, and b) reduce disparities in TBI-related care and outcomes.

Applicants are expected to focus on the following research questions:

1. What type of disparities in mTBI-related processes and outcomes currently exist at baseline in a healthcare system(s) prior to initiation of an intervention to systematically implement CDC’s Pediatric mTBI Guideline?

2. Does an intervention aimed at systematically implementing CDC’s Pediatric mTBI Guideline in a healthcare system(s) result in a reduction of health disparities, relative to baseline, vis a vis improved process and health outcomes? Applicants are encouraged to supplement the mTBI Guideline implementation with added outreach efforts to children return to school and return to play, communication with the school about symptoms, recovery, accommodations) as well as health outcomes. An indicator of care might be length of time between injury and diagnosis and treatment of an mTBI or the recovery trajectory of an mTBI.

Disparities (health outcomes seen to a greater or lesser extent between populations) may be related to various factors of the injured child or adolescent, their family or neighborhood, or community, such as race, gender, sexual identity, disability, socioeconomic conditions, or geographic location.

Funds are available for an implementation study to promote the adoption and integration of the Guideline into routine health care to improve the impact on population health. Implementation should focus on groups for which there are known disparities in TBI-related outcomes. Funds are not available to support TBI-related diagnostics or care activities.

Minority Serving Institutions: This NOFO seeks diversity among applicant institutions, research investigators, and partnering organizations to ensure researcher experience and research outcomes are applicable and beneficial to all segments of our population and social ecology.

Applicants from or collaborating with Minority Serving Educational Institutions (MSIs) representative of and serving the community participating in the evaluation are highly encouraged. For the purpose of this NOFO, MSIs include Hispanic Serving Institutions (HSIs), Historically Black Colleges and Universities (HBCUs), Tribal Colleges and Universities (TCUs), and Alaska Native and Native Hawaiian Serving Institutions, as defined by the U.S. Department of Education. Meritorious applications from eligible MSIs or eligible institutions collaborating with MSIs, as evidenced by MSI inclusion in the SF-424 Senior/Key Personnel form, may be considered during the second level of review to broaden distribution of awards (see Section V.

Application Review Information 4. Review and Selection Process).

Healthy People 2030 and other National Strategic Priorities The proposed research addresses the NCIPC Research Priority of evaluating the effectiveness of strategies for preventing all forms of traumatic brain injury (TBI) and enhance the recognition and management of mild TBI in clinical and community settings1, and is described in the NCIPC's research priorities (https://www.cdc.gov/injury/researchpriorities/index.html).

The proposed research also addresses “Healthy People 2030” goals for injury and violence prevention and improving the health as described in https://www.health.gov/healthypeople.

Specifically, this NOFO supports the following objectives:

Reduce fatal injuries— IVP-01 Reduce emergency department visits for non-fatal injuries — IVP-02 Reduce emergency department visits for non-fatal unintentional injuries — IVP-04 Reduce fatal traumatic brain injuries —IVP-05

Public Health Impact The increase in the number of pediatric patients with mTBI combined with challenges in providing evidence-based diagnosis and management strategies and the uneven use of those strategies across the country are a significant public health problem. The goals of this research funding are to demonstrate the effectiveness of an intervention informed by an evidence-based guideline to: a) improve mTBI outcomes in children and adolescents, and b) reduce disparities in TBI-related care and health outcomes.

Relevant Work CDC’s research and programs work to prevent TBI and help people to better recognize, respond, and minimize the consequences of TBI. Working with states and other partners, CDC supports evidence-based strategies to prevent TBI and promote healthy lifestyles that can improve the quality of life for people living with TBI. Recently, NCIPC developed research priorities to identify effective strategies for enhancing management of mTBI in clinical settings. These activities are outlined in the CDC NCIPC Research Priorities report that can be found at:

http://www.cdc.gov/injury/researchpriorities/index.html.

The CDC NCIPC Board of Scientific Counselors established the Pediatric mTBI Guideline workgroup to systematically review the literature and draft recommendations for providers https://www2.ed.gov/about/offices/list/ocr/edlite-minorityinst-list-tab.html https://www2.ed.gov/about/offices/list/ocr/edlite-minorityinst-list-tab.html http://www.cdc.gov/injury/researchpriorities/index.html) https://www.health.gov/healthypeople http://www.cdc.gov/injury/researchpriorities/index.html related to the diagnosis and management of pediatric mTBI. These evidence-based recommendations were developed into CDC’s Pediatric mTBI Guideline available here:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7006878/ Since its publication, this Guideline has been used to help educate and support clinicians in implementing best practices for pediatric mTBI diagnosis and management. CDC has developed a suite of tools for healthcare providers, patients, and their families to implement the Guideline recommendations. Those tools are available here: https://www.cdc.gov/traumaticbraininjury/PediatricmTBIGuideline.html

For over a decade, the Injury Center’s HEADS UP campaign has played a prominent role in the public health response to concussion. HEADS UP is a series of educational initiatives that all have a common goal: Protect kids and teens by raising awareness and informing action to improve prevention, recognition, and response to concussion and other serious brain injuries.

HEADS UP educational materials are designed to help support individuals and organizations with their concussion reduction efforts and are available in a variety of formats. CDC has created practical, easy-to-use clinical information and tools for health care providers and their patients, including free online training that offers free continuing education credits, available at https://www.cdc.gov/headsup/providers/index.html.

References:

1. Centers for Disease Control and Prevention. National Center for Injury Prevention and Control. Our Approach. Available at: https://www.cdc.gov/injury/about/approach.html.

Accessed 5/22/2021.

2. Arbogast, KB, Curry, PhD, AB, Pfeiffer, MR, Zonfrillo,MR, Haarbauer-Krupa, J, Breiding, MJ. Coronado, VG, & Master, CL., Point of health care entry for youth with concussion within a large pediatric care network. JAMA Pediatrics. 2016; e160294-e160294.

3. Upchurch C, Morgan C, Umfress A, Yang G, Riederer, M. (2014). Discharge instructions for youth sports-related concussions in the emergency department, 2004 to 2012. Clinical Journal of Sports Medicine. 2014; 25(3), 297-299

4. Zonfrillo MR, Master CL, Grady MF, Winston FK, Callahan JM, Arbogast KB. Pediatric providers’ self-reported knowledge, practices, and attitudes about concussion. Pediatrics.

2012;130(6):1120-1125.

5. Kaye AJ, Gallagher R, Callahan JM, Nance ML. Mild traumatic brain injury in the pediatric population: the role of the pediatrician in routine follow-up. J Trauma.

2010;68(6):1396-1400.

6. Carl RL, Kinsella SB. Pediatricians’ knowledge of current sports concussion legislation and guidelines and comfort with sports concussion management: a cross-sectional study.

Clinical Pediatrics. 2014;53(7):689-697.

7. Daugherty J, Waltzman D, Sarmiento K, Xu L. Traumatic brain injury–related deaths by race/ethnicity, sex, intent, and mechanism of injury — United States, 2000–2017. MMWR Morbidity and Mortality Weekly Report. 2019;68(46):1050-1056.

8. Rutland-Brown W, Wallace L, Faul M, Langlois J. Traumatic brain injury hospitalizations among American Indians/Alaska Natives. Journal of Head Trauma Rehabilitation. 2005;20(3):205-214.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7006878/ https://www.cdc.gov/traumaticbraininjury/PediatricmTBIGuideline.html https://www.cdc.gov/headsup/providers/index.html https://www.cdc.gov/injury/about/approach.html

9. Langlois J, Kegler S, Butler J, et al. Traumatic brain injury-related hospital discharges:

Results from a 14-state surveillance system, 1997. MMWR Surveillance Summary.

2003;52(4):1-20.

10. Peterson AB, Sarmiento K, Xu L, Haileyesus T. Traumatic brain injury-related hospitalizations and deaths among American Indians and Alaska natives – United States, 2008-2014. Journal of Safety Research. 2019;71:315-318.

11. Dismuke C, Gebregziabher M, Egede L. Racial/Ethnic disparities in VA services utilization as a partial pathway to mortality differentials among Veterans diagnosed with TBI. Global Journal of Health Science. 2015;8(2):260-272.

12. Jimenez N, Quistberg A, Vavilala M, Jaffe K, Rivara F. Utilization of mental health services after mild pediatric traumatic brain injury. Pediatrics 2017;139(3):e20162462.

13. Jimenez N, Symons RG, Wang J, et al. Outpatient rehabilitation for Medicaid-insured children hospitalized with traumatic brain injury. Pediatrics 2016;137(6):e20153500.

14. Meagher A, Beadles C, Doorey J, Charles A. Racial and ethnic disparities in discharge to rehabilitation following traumatic brain injury. Journal of Neurosurgery. 2015;122(3):595-601.

15. Schiraldi M, Patil C, Mukherjee D, et al. Effect of insurance and racial disparities on outcomes in traumatic brain injury. Journal of Neurological Surgery. 2015;76(3):224- 232.

16. Asemota A, George B, Cumpsty-Fowler C, Haider A, Schneider E. Race and insurance disparities in discharge to rehabilitation for patients with traumatic brain injury. Journal of Neurotrauma. 2013;30(24):2057-2065.

17. Arango-Lasprilla J, Ketchum J, Gary K, et al. Race/ethnicity differences in satisfaction with life among persons with traumatic brain injury. NeuroRehabilitation. 2009;24(1):5- 14.

18. Arango-Lasprilla J, Ketchum J, Lewis A, Krch D, Gary K, Dodd B. Racial and ethnic disparities in employment outcomes for persons with traumatic brain injury: A longitudinal investigation 1-5 years after injury. PM & R. 2011;3(12):1083-1091.

19. Arango-Lasprilla J, Kreutzer J. Racial and ethnic disparities in functional, psychosocial, and neurobehavioral outcomes after brain injury. Journal of Head Trauma Rehabilitation. 2010;25(2):128-136.

20. Arango-Lasprilla J, Rosenthal M, Deluca J, et al. Traumatic brain injury and functional outcomes: does minority status matter? Brain Injury. 2007;21(7):701-708.

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https://www.who.int/social_determinants/publications/9789241500852/en/. Retrieved on July 7, 2020.

2. Approach For NOFO RFA-CE-22-007, applicants are expected to propose a rigorous study design (e.g., randomized controlled trial, quasi-experiment) to evaluate the implementation of CDC’s Pediatric mTBI Guideline. The applicant is expected to implement all facets of the Guideline including clinician education, electronic clinical decision support, and customized discharge instructions. Applicants should also employ enhanced outreach to children experiencing disadvantage and their families/schools/community organizations, and consider enhanced connections to schools to improve a child’s adjustment upon their return to school. Applicants are expected to first assess and analyze mTBI-related processes and outcomes to delineate existing disparities (that is, establish a baseline) prior to implementation of the Guideline, and to implement the Guideline in a manner that seeks to reduce disparities. Applicants who can articulate already-identified TBI-related disparities in their applications, then indicate how they plan to subsequently focus on those disparities through the proposed intervention, are preferred.

Applicants are expected to clearly justify their choice of health-care system. Applicants are expected to demonstrate the ability to measure both changes in mTBI outcomes and changes in health disparities. Applicants are also expected to describe the potential generalizability of their https://www.who.int/social_determinants/publications/9789241500852/en/ results to other health-care systems.

Applicants are expected to study adoption, integration, and patient outcomes of an intervention focused on improving personalized diagnosis, management, and treatment of pediatric mTBI based largely on evidence-based recommendations outlined in CDC’s Pediatric mTBI Guideline.33 For the purpose of this NOFO the ‘intervention’ consists of clinician education, electronic clinical decision support, customized discharge instructions, enhanced outreach to children experiencing disadvantage and their families/schools/community organizations, and enhanced connections to schools to improve a child’s adjustment upon their return to school.

Discharge instructions are expected to include protocols outlining parent-friendly instructions describing best practices for the management of symptoms at home and at school, including Return to Learn (RTL) and Return to Play (RTP) protocols. The education, support, and discharge instructions are expected to be designed for implementation in primary care and/or emergency department settings, but could also include specialty care (e.g., sports medicine, and clinics that serve children with mTBI) and urgent care. Projects that extend RTL and RTP protocols beyond guidance provided in discharge instructions and incorporate continued engagement between the health and education systems and sports programs, are preferred.

Applicants should take care to ensure appropriateness of the control/comparison group, and analytic plans should anticipate and evaluate the effects of threats to the internal and external validity of the research design, including adjusting for history effects (e.g., changes in health system, state, or federal policies or guidelines specifying protocols of care over time). Applicants should include research plans that describe the research questions, study design, hypotheses, sample to be studied, recruitment strategies, data collection measures, sources, time points, procedures, analytic strategy, and estimated sample size and power for each proposed hypothesis. Applicants are expected to identify key outcomes for each research question to determine whether the intervention improves clinical care and health outcomes and reduces health disparities. Examples of primary outcomes include reductions in length of time between injury diagnosis and treatment and symptom resolution time, improved recovery trajectories, reduction in concussion-related complications (e.g., educational difficulties), greater adherence to RTL and RTP recommendations, better academic performance, and increased utilization of needed accommodations and services. Examples of secondary outcomes include: improvement in the sensitivity and specificity of TBI diagnosis, utilization of best practices in diagnosis (e.g., visual-oculomotor screening, use of validated symptom inventories) and management (e.g., provision of RTL and RTP instructions; increased communication with coaches, teachers, parents), increase in follow-up by patients and their caregivers (e.g. follow-up medical appointments when needed, monitoring of symptoms by patients and their caregivers).

Applicants should attend to methods for outcome measurement that reduce bias (e.g., inclusion of multiple forms of measurement, such as through electronic health record documentation as well as patient interviews/surveys). Research plans that include health systems with integrated emergency departments, examine the intervention in multiple clinical settings (primary care, ED, specialty clinics, urgent care), and allow for multi-site investigations are preferred.

It is anticipated that before implementation of the intervention applicants will propose to obtain information on disparities within their healthcare system for TBI patients, and then use that information to inform intervention implementation.

Funds are available for an implementation study to promote the adoption and integration of the Guideline into routine health care to improve the impact on population health. Implementation should focus on groups for which there are known disparities in TBI-related outcomes. Funds are not available to support TBI-related diagnostics or care activities.

The first paragraph of the Specific Aims section of the application must clearly describe the primary goals and objectives of the proposed research and the prevention approach that will be evaluated. Applications that do not clearly propose to demonstrate the effectiveness of an intervention informed by CDC’s Pediatric mTBI Guideline, to: a) improve mild traumatic brain injury (mTBI) outcomes in children and adolescents, and b) reduce disparities in TBI-related care and outcomes, as evidenced by the Specific Aims section of the application's research plan, will be considered nonresponsive and will not be forwarded for peer review.

Applications must be responsive to NOFO RFA-CE-22-007 in order to be forwarded for peer review. Additional responsiveness criteria are listed in Section III. Eligibility Information 5.

Responsiveness of this NOFO. It is the applicant’s responsibility to ensure that the submitted research proposal meets all responsiveness criteria listed in Section III. Eligibility Information 5.

Responsiveness.

Objectives/Outcomes The primary objective of this research is to demonstrate improved mTBI outcomes in children (health, educational, and social) and a reduction in disparities in outcomes between identified subpopulations.

Primary Outcomes Examples of specific primary outcomes include reductions in length of time between injury diagnosis and treatment and symptom resolution time, improved recovery trajectories, reduction in concussion-related complications (e.g., educational difficulties), greater adherence to RTL and RTP recommendations, better academic performance, and increased utilization of needed accommodations and services. Other primary outcomes should include any disparities in health or educational outcomes identified through the pre-intervention assessment. Other primary outcomes should include any disparities in processes identified through the pre-intervention assessment.

Secondary Outcomes Examples of secondary outcomes include: improvement in the sensitivity and specificity of TBI diagnosis, utilization of best practices in diagnosis (e.g., visual-oculomotor screening, use of validated symptom inventories) and management (e.g., provision of RTL and RTP instructions;

increased communication with coaches, teachers, parents), increase in follow-up by patients and their caregivers (e.g. follow-up medical appointments when needed, monitoring of symptoms by patients and their caregivers). Applicants should attend to methods for outcome measurement that reduce bias (e.g., inclusion of multiple forms of measurement, such as through electronic health record documentation as well as patient interviews/surveys).

Rigorous evaluation designs. Evaluations must use rigorous experimental or quasi-experimental designs that are able to demonstrate the impact of the approach on the proposed outcomes of interest. For the purposes of this research opportunity, rigorous evaluation designs include those that utilize experimental designs (randomized controlled trials) or rigorous quasi-experimental designs (e.g., comparative interrupted time series design, difference-in- differences, instrumental variable methods, regression discontinuity, regression point displacement, stepped wedge, propensity-score matching, matched comparison groups).

Data collection, acquisition, and analysis. Applicants must identify and describe appropriate data sources and provide evidence of their ability to acquire and/or collect data of sufficient quantity and quality to conduct a rigorous evaluation. Applications should clearly describe and justify the proposed sampling methods, sample size, power estimates, and data collection methods for the proposed outcome(s). The timeline for data acquisition (requests for extant data and or primary data collection) must be specified.

Protection of Human Subjects and Personally Identifiable Information The Research Strategy section of the application is expected to clearly describe the type, source, access to, and protections of the data and human subjects participating in the study. Access to non-publicly available, previously collected data must be clearly described in the Research Strategy and documented with a signed Data Sharing Agreement or Letter of Support. Access to publicly available, previously collected data must be clearly described in the Research Strategy.

Protection of previously collected data includes, but is not limited to, protection of personally identifiable information from loss and/or misuse.

The application is expected to identify each performance site…