NIH – Medical Simulators for Practicing Patient Care Providers Skill Acquisition, Outcomes Assessment and Technology Development (R01 Clinical Trial Not Allowed)

November 27, 2018 by School of Medicine Webmaster

Simulation applications for gastrointestinal endoscopy and laparoscopic surgery were introduced in the early 1990s and followed the development of simulation-based methods for anesthesia care, team training, and crisis management. With the development of simple “box trainers” surgical skill acquisition for basic laparoscopic procedures was possible on a wide-spread and economical basis, and the development of virtual reality trainers for advanced laparoscopic and catheter-based procedures prompted an expanded role of simulation in the graduate medical education domain. The impact of simulation adoption on the quality of healthcare delivered by practicing clinicians has received little attention, however, and this deficiency was recently explored in a workshop jointly sponsored by The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the National Institute of Biomedical Imaging and Bioengineering (NIBIB).

The acquisition of “expert” levels of proficiency for academic trainees through the use of simulation-based methods has been shown to reduce intraoperative errors, reduce intra- and post-operative complications, and reduce patient length-of-stay when applied to resident learning experiences , but similar studies that examine the role of simulation on reducing errors or improving outcomes for practicing clinicians are lacking. Similarly, a pre-operative “warm up” with a simulator has been shown to result in a significant improvement in resident performance , but no similar study has examined the possible benefit of a pre-operative simulation-based skill rehearsal on the performance of practicing clinicians. Simulation applications have been developed for specific procedure-related skill acquisition with on-site mentorship of trainees, but the benefit of simulation-based skills training for the recognition and management of rare adverse events by practicing clinicians has been largely unexplored. More fundamentally, it is unknown whether the same schedule and frequency of simulation training used by trainees are associated with maximum or best skill acquisition and maintenance by experienced clinicians.

It is assumed that maximum safety and outcomes achievable in the procedure-related specialties correlates with the degree of procedural mastery possessed by the clinicians. Procedural mastery is a combination of technical mastery and expert judgment, and methods to improve the performance of experienced clinicians toward the goal of procedural mastery may benefit from simulated scenarios which support the acquisition and maintenance of both technical skills and judgmental skills.   The development, evaluation and validation of simulation applications which support judgmental skill acquisition have largely been unexplored.

The importance of simulation-based training and the role of simulation in the enhancement of clinical safety and outcomes have been recognized increasingly over the past few years. There are now 96 accredited advanced education centers which provide access to simulation models and methods, and this follows the ubiquitous development of simulation centers and laboratories at virtually all teaching hospitals in this country.

With the awareness that medical error contributes significantly to the morbidity, mortality and costs of healthcare, and the demonstration that some practicing clinicians demonstrate below-average levels of clinical skills, there is increased interest to explore simulation-based training as a means of improving the quality of healthcare.

Research Objectives 

The purpose of the Funding Opportunity Announcement (FOA) is to develop, evaluate and validate methods by which simulation technologies can be used by practicing clinicians for the purpose of acquiring, maintaining, and improving skills which are critical for optimal safety, outcomes and benefits of care delivered to patients.
The three focus areas of this FOA are:

  1. Skill Acquisition – Applications which address the processes of skill acquisition, skill maintenance, and skill enhancement for practicing clinicians and healthcare providers. Applications to evaluate simulation-based approaches to procedural error analysis and error prevention are sought, as are applications to establish the most effective methods for the acquisition and maintenance of skills by experienced clinicians. Studies which assess the method and time course of skill acquisition and maintenance by experienced clinicians through the use of simulation devices and/or applications are appropriate for this FOA. Before-and-after trials of simulation-based training on measurable effects of healthcare delivery are considered clinical trials and are not accepted by this FOA .  Applications which propose clinical trials of interest to NIDDK must be directed to PA-18-330: Investigator-Initiated Clinical Trials Targeting Diseases within the Mission of NIDDK (R01 Clinical Trial Required), as described under the NIDDK Interest Statement below.
  2. Outcomes Assessment – Applications which assess the skills of experienced clinicians and correlate the simulation-based assessment of skill levels with the quality of care experienced by patients treated by these care-givers, including factors such as safety (e.g., morbidity and mortality), outcomes (e.g., being free of disease/condition, recovery and rehabilitation from interventions) and costs (e.g., length of hospital stay, cost of treatment). Studies which compare clinical skill measurement by simulation methods with the outcomes of patients treated by those practitioners whose skills have been assessed are appropriate for this FOA.  Randomized controlled trials on measurable effects of healthcare delivery are considered clinical trials and are not accepted by this FOA. Applications which propose clinical trials of interest to NIDDK must be directed to PA-18-330, as described under the NIDDK Interest Statement below.
  3. Technology development – Projects to develop “virtual coaches” by incorporating intelligent methods into existing simulators to provide adaptive, cognitive assistance to coach experienced practitioners in retaining, retraining and improving performance levels in the context of the user environment. Technological solutions that incorporate artificial intelligence with theory-driven, physics-based, physiologically realistic models are strongly encouraged.  Simulators should replicate “real life” work flows, including planning, warm-up exercises, and rehearsal leading up to the actual procedure.  The resulting technology outcome is a “virtual coach” based on physiologically realistic models that operate in real-time, capable of seamless integration in a variety of provider environments; including rural and low-resource settings.  Applications should incorporate end users as part of the technology development team.

Existing simulation methods may include mannequins, standardized patients, task trainers, and procedure-specific trainers of either the virtual (computer assisted) or actual type (cadavers). Applications which propose to use endoscopic, videoscopic (laparoscopic), and robotic simulation techniques are welcome, as are standardized patients, and the depiction or portrayal of rare adverse events or specific procedures. NIH encourages a variety of simulation projects from across the healthcare spectrum which impact diverse patient populations, including priority populations, provider groups and clinical settings. Priority populations include: low income groups, minority groups, women and children, the elderly, and individuals with special healthcare needs. Diverse settings of care might include but are not limited to hospitals, ambulatory surgical and endoscopy centers, primary care clinics, medical centers, healthcare provider organizations, healthcare systems, professional health organizations and societies, as well as quality and safety improvement organizations.

Applications which are directed at team training, crisis management, or communication skills are not considered appropriate for this funding announcement. Improvement of technical skills, and the application of procedure-related simulation, are the primary focus of this FOA.

Specific Interests

The following section briefly describes the specific interests of the participating funding components of this FOA. All interests are examples and are not limited to these cases.  Applicants are strongly encouraged to contact the funding components.

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is interested in applications targeted to focus areas 1 and 2, concentrating on abdominal, gastroenterological, and urological diseases and conditions.  Studies which quantify or otherwise assess skills of practicing clinicians by the use of a task simulator and compare those skill assessments to the measured outcomes (e.g., morbidity, mortality or cost) of those patients treated by the clinicians are of interest.  These studies constitute an observational study (and not constitute a clinical trial) and would be of interest to NIDDK for this FOA.

NIDDK Clinical Trial Guidance.  Applications which propose clinical trials related to the diagnosis and treatment of diseases or conditions of interest to NIDDK (abdominal, gastrointestinal, and urologic diseases and conditions) and which are related to this announcement must be directed to PA-18-330 (Investigator-initiated Clinical Trials Targeting Diseases Within the Mission of NIDDK). A guideline for defining a clinical trial is available at https://grants.nih.gov/policy/clinical-trials/case-studies.htm. The study elements which qualify for designation as a clinical trial include the following:

  1. An intervention is employed in human subjects (which might include patients or healthcare providers)
  2. The subjects are prospectively assigned to the intervention(s)
  3. The study is designed to assess the effects of the intervention on the subjects
  4. The effects of the intervention are assessed as health-related outcomes.

Therefore, applications which propose to develop, evaluate and validate simulation-based methods for the acquisition, improvement and maintenance of skills by practicing clinicians may be considered clinical trials if an intervention is employed, and the effects of that intervention on health-related outcomes are assessed.

Applications which seek to improve the acquisition, or maintenance of clinically relevant skills of practicing clinicians through a comparison of methods (interventions) or before-and-after assessments of clinical outcomes after instituting a proficiency-based program of skill attainment on a task simulator would be designated as clinical trials, by the guidelines for clinical trials referred to above, and must be directed to PA-18-330 for applications of interest to NIDDK.

Applications which are directed to PA-18-330 should reference this funding announcement in the rationale and significance portions of the application
Applications which seek support for pilot studies for clinical trials according to the definition above should be directed to Pilot and Feasibility Clinical and Translational Research Studies in Digestive Diseases and Nutrition (R21 Clinical Trial Optional).

The National Institute of Biomedical Imaging and Bioengineering (NIBIB) is interested in supporting applications targeted to focus area 3, enhancing medical simulation technologies using multiple disease or conditions as testbeds for the technology development. Complicated or rare procedures, relevant to skilled practitioners in rural and low-resource settings are especially encouraged.

The NIBIB is interested in promoting the development of medical simulation technologies that have broad diagnostic, therapeutic and interventional applications in diseases or health conditions. Areas of interest include medical simulation technologies to complement technology development in all other program areas of the NIBIB, https://www.nibib.nih.gov/research-funding.

NIBIB will support applications that develop novel medical simulation technology solutions that can broadly apply to multiple disease and conditions.  NIBIB will support an application focused on a single disease or condition if it is clear that the single disease or condition is an initial test bed for a medical simulation technology that could be applied to other diseases or conditions. NIBIB will not support any applications that are solely using and not developing enhanced medical simulation technologies. NIBIB will not support any applications targeted for focus areas 1 and 2.

Deadlines:  standard dates apply

URL:  https://grants.nih.gov/grants/guide/pa-files/PA-19-065.html

Filed Under: Funding Opportunities