QAs_CE22-007_TBI_Final.pdf

RFA-CE-22-007; Reduce Health Disparities and Improve Traumatic Brain Injury (TBI) Related Outcomes Through the Implementation of CDC’s Pediatric Mild TBI Guideline

Questions and Answers received from December 8 to January 10, 2022.

Q1. Are applicants expected to evaluate the CDC pediatric mTBI guidelines for concussion only within the primary care/pediatric environment or would a proposal that focused on pediatric presentation to the ED and Urgent Care be responsive to the RFA?

A1. As stated in Section I. Funding Opportunity Description, 2. Approach, “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.” The intervention is “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.”

Q2. The RFA indicates a preference for studying a health system with integrated points of care. Is there an expectation that multiple systems will be studied (i.e., with randomization), or would a single system (i.e., with pre-post data collection) be acceptable?

A2. As stated in Section I. Funding Opportunity Description, 2. Approach, this NOFO seeks applications that propose rigorous study designs to evaluate the implementation of CDC’s Pediatric mTBI Guideline. For the purposes of this NOFO, 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).

The study design may include multiple health-care systems or just one health-care system.

Applicants are expected to:

• Justify their choice of health-care system,

• Demonstrate the ability to measure both changes in mTBI outcomes and changes in health disparities, and

• Describe the potential generalizability of their results to other health-care systems.

Q3. Within a given system, is the expectation/preference that all points of care be equally emphasized, or would it be acceptable to predominantly focus intervention efforts on a single high impact point (i.e., emergency department)

A3. As stated in Section I. Funding Opportunity Description, 2. Approach, applicants are expected to:

• Implement all facets of the Guideline including clinician education, electronic clinical decision support, and customized discharge instructions;

• 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; and

• Implement the Guideline in a manner that seeks to reduce disparities; and

• Assess and analyze mTBI-related processes and outcomes to delineate existing disparities (that is, establish a baseline) prior to implementing the Guideline.

It will be incumbent on the applicant to clearly describe intervention and implementation, and demonstrate how the they would lead to improvements in mTBI outcomes and reductions in health disparities.

Q4. In terms of the timeline of up to 4 years, is there a preference for intervention duration?

For example, would it be acceptable to have an initial formative/organizational/baseline year, two intervention years, and a final data analysis dissemination year?

A4. This NOFO does not require or specify the period of time expected for the intervention to be in use. It will be incumbent on the applicant to clearly describe all facets of the proposed study and demonstrate the ability to evaluate the intervention for improvements in mTBI outcomes and reductions in health disparities.