Official Title
COVID-19 Responsive Intervention: Systems Improvement Simulations (CRI:SIS) Randomized Control Trial
Brief Summary

This will be a randomized control trial assessing the impact of CRI:SIS as a simulation-based preparedness intervention on physician stress levels through changes to heart rate variability (HRV) on shift while caring for COVID-19 patients and post-shift anxiety as measured by the State-Trait Anxiety Inventory (STAI). The aim is to test CRI:SIS to determine its effect on mitigating physician stress on shift and anxiety post-shift related to provision of COVID-19 care

Detailed Description

The overall goal of this study is to develop and test the COVID-19 Responsive Intervention:
Systems Improvement Simulations (CRI:SIS), a simulation-based training and quality
improvement intervention that will minimize physician stress and improve system
responsiveness. To accomplish this goal, the investigators will conduct a two-site randomized
clinical trial to test the efficacy of CRI:SIS as a simulation-based preparedness
intervention on decreasing emergency physician stress and anxiety during the care of COVID-19
patients in the ED through on-shift measurements of heart rate variability as a physiologic
marker of stress and responses to the State-Trait Anxiety Inventory post-shift. The
investigators will rapidly disseminate CRI:SIS as two simulation interventions, one on
clinician preparedness and the other on system improvement, through interactive virtual
tele-simulations, webinars, and virtual workshops providing mentorship and shared learning
for other institutions facing similar challenges. If proven successful, the simulation-based
CRI:SIS intervention to rapidly prepare clinicians and improve system responsiveness can be
widely disseminated to other institutions to combat the anticipated lengthy response to
COVID-19 safety challenges.

Participants randomized to the intervention arm will receive CRI:SIS as a three-hour
simulation session. This session will include three scenarios focused on three critical areas
of COVID-19 patient care:

1. airway management procedures in patients with COVID-19 given increased risk of viral
transmission to personnel and rapid respiratory deterioration in infected patients

2. new presenting symptoms and associated complications of COVID-19 (e.g.,
hypercoagulability, cardiovascular morbidity), making accurate diagnosis and treatment
of patients with suspected infection difficult

3. caring for patients presenting with severe illness and poor prognosis adding emotional
and cognitive strain to physicians as they initiate palliative care, discuss goals of
care, or withdraw care in the ED.

In addition, all three scenarios will address negative effects on team performance during
COVID-19 care from social distancing and personal protective equipment (PPE) requirements
through interactions with nursing and ancillary staff confederates during each scenario. Each
participant will complete all three scenarios within a three-hour block between one to five
days prior to a clinical shift.

Participants randomized to the control arm will participate in four shift data collections,
with no additional intervention. These participants will have access to the routinely
distributed COVID-19 Task Force updates, guidelines, weekly town hall meetings, and any
in-service support that would routinely be available to all clinical staff as per standard
operational practice in our local departments. Once enrollment for Aim 2 is complete, all
participants randomized to the control arm will be offered the opportunity to complete the
simulation intervention.

Completed
Physician Stress Levels

Behavioral: Simulation Intervention

Participants randomized to the intervention arm will receive CRI:SIS as a three-hour simulation session.

Behavioral: Control

Participants randomized to the control arm will participate in four shift data collections, with no additional intervention.

Eligibility Criteria

Inclusion Criteria:

- Resident or Attending Physician working at Yale New Haven Hospital York Street or
Saint Raphael Emergency Departments

- Currently treating patients with COVID-19 or suspected COVID-19

Exclusion Criteria:

- Currently taking a beta-blocker and/or anti-arrhythmic medication

- Active (uncontrolled) thyroid dysfunction

- Pregnant

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

Yale New Haven Hospital
New Haven, Connecticut, United States

Leigh Evans, MD, Principal Investigator
Associate Professor of Emergency Medicine; Executive Director, Yale Center for Medical Simulation; Director, Resident Research

Agency for Healthcare Research and Quality (AHRQ)
NCT Number