Medical Simulators for Practicing Patient Care Providers Skill Acquisition, Outcomes Assessment and Technology Development (R01 Clinical Trial Not Allowed) | PA 19 065

FAQs: NIH PA-19-065 (R01) Medical Simulation Research for Practicing Clinicians (Clinical Trial Not Allowed)

1) What is PA-19-065 trying to fund?

PA-19-065 is an NIH funding opportunity that supports R01 research projects focused on medical simulation for practicing patient care providers. The central purpose is to strengthen patient safety and real-world healthcare outcomes by improving how simulation technologies help experienced clinicians learn, maintain, assess, and refresh complex clinical skills over time.

2) Who is the intended participant group for the simulation research?

The focus is on experienced clinicians and practicing patient care providers, not students or trainees. Projects should be designed around the realities of seasoned providers, such as sustaining proficiency in rarely performed but high-risk procedures, learning updated techniques, and maintaining performance under stress and time pressure.

3) What funding mechanism is used for this opportunity?

The opportunity uses the NIH R01 mechanism (research project grant).

4) Which agency sponsors this funding opportunity?

The sponsoring agency is the National Institutes of Health (NIH).

5) What does "Clinical Trial Not Allowed" mean for this FOA?

It means applicants must propose research that does not meet NIH's definition of a clinical trial. The proposal should avoid study designs that would be considered clinical trials under NIH rules, such as assigning people to different training conditions and evaluating health-related outcomes.

6) What types of studies are suggested as potentially appropriate under "Clinical Trial Not Allowed"?

Examples described as potentially fitting include technology development, validation studies, and observational studies linking simulator performance to clinical care quality. The key is that the research does not meet NIH's definition of a clinical trial.

7) What types of studies might be problematic under this FOA because they could be considered a clinical trial?

Interventional studies that assign participants to different training conditions and then evaluate health-related outcomes may meet NIH's definition of a clinical trial and therefore may not be allowable under this announcement.

8) What are the main research tracks in this FOA?

The FOA is organized around three major tracks: (1) Skill Acquisition, (2) Outcomes Assessment, and (3) Technology Development (with special interest in virtual coaches).

9) What kinds of projects fit the Skill Acquisition track?

This track emphasizes developing and testing simulation-based strategies, training protocols, and practice schedules that help experienced clinicians acquire new skills or prevent skill decay in established skills. It centers on how to support long-term retention and reliable execution in actual clinical settings.

10) What training and practice variables are highlighted in the Skill Acquisition track?

The FOA points to questions such as which types of simulation practice best support long-term retention, including distributed practice, deliberate practice, refresher intervals, feedback style, and scenario design.

11) Why does the FOA emphasize the "unique needs" of seasoned providers?

Because practicing clinicians often need to maintain proficiency in procedures that are rare but high risk, adapt to updated techniques, and sustain performance under real-world pressures like stress and time constraints. The FOA is aimed at research that addresses those realities directly.

12) What is the focus of the Outcomes Assessment track?

Outcomes Assessment is about measuring clinician competence using simulators in a way that is meaningful, reliable, and connected to the quality of care delivered. A major theme is understanding whether simulator-based assessment results predict or correlate with real clinical performance and clinically relevant indicators.

13) What real-world indicators does the FOA mention for linking simulation performance to clinical care?

The FOA mentions indicators such as patient care quality, safety events, procedural success, adherence to best practices, and other clinically relevant measures.

14) What kinds of measurement improvements are encouraged under Outcomes Assessment?

The FOA encourages strengthening validity evidence, improving scoring rubrics, developing more sensitive performance metrics, reducing measurement noise, improving inter-rater reliability, and developing assessment strategies that better reflect real-world complexity.

15) What does "real-world complexity" include in this context?

The FOA explicitly notes elements like teamwork, decision-making, situational awareness, and management of complications as important aspects that assessment strategies may need to capture.

16) What is the Technology Development track about?

This track supports enhancements to simulation platforms by integrating intelligent or adaptive technologies that can guide experienced users during practice. The aim is to move beyond passive simulation and toward systems that provide tailored, context-aware coaching and cognitive assistance.

17) What are "virtual coaches" as described in this FOA?

"Virtual coaches" refer to intelligent or adaptive features embedded into simulation systems that provide tailored guidance. Examples include adaptive feedback that changes based on a clinician's demonstrated weaknesses and embedded tutoring that responds to decisions in real time.

18) What is the practical goal of virtual coach-style technology development?

The goal is practical performance support: tools that help clinicians retain competence, regain proficiency after time away, and improve performance efficiently without needing constant human instructor time.

19) Does the FOA require that simulation-based improvements translate to patient safety or healthcare outcomes?

The stated core aim is to strengthen patient safety and real-world healthcare outcomes, and the tracks (especially Outcomes Assessment) emphasize connecting simulator performance and assessment to clinical performance and care quality indicators.

20) Who is eligible to apply?

Eligibility is broad and includes many U.S. applicant types: state, county, and local governments; special districts; independent school districts; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities; nonprofits (501(c)(3) and non-501(c)(3)); for-profit organizations (other than small businesses) and small businesses; and other organizations.

21) Are minority-serving institutions and community-based organizations included in eligibility?

Yes. The announcement explicitly highlights eligible categories such as HBCUs, Hispanic-serving institutions, AANAPISISs, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.

22) Can non-U.S. organizations apply as the primary applicant?

No. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as applicants under this FOA.

23) Can a U.S.-based organization include a non-U.S. site or activity?

Non-domestic components of U.S. organizations are not eligible. However, "foreign components" are allowed under NIH policy, meaning a U.S.-based applicant may include certain well-justified international elements if they meet NIH definitions and requirements.

24) What CFDA numbers are associated with this opportunity?

The opportunity is listed under CFDA numbers 93.286 and 93.847.

25) What is the posted closing date and why should applicants double-check it?

The closing date shown is January 7, 2022. Applicants should confirm whether the FOA is still active, reissued, or replaced by a newer announcement, since NIH opportunities are often updated or superseded.

26) When was the opportunity record created?

The record creation date shown is November 13, 2018.

27) What is the overarching theme across all three tracks?

Across Skill Acquisition, Outcomes Assessment, and Technology Development, the theme is rigorous, non-clinical-trial research that improves simulation for experienced clinicians, strengthens measurement and its connection to real clinical care quality, and advances simulation technology toward intelligent, adaptive coaching that supports sustained high performance and reduces patient risk.