Clinical trial NCT04614844: COVID-19 Responsive Intervention: Systems Improvement Simulations (CRI:SIS)
Official title: COVID-19 Responsive Intervention: Systems Improvement Simulations (CRI:SIS) Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physician Stress Levels
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2020-11-04
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Change in end-of-shift heart rate variability
timeFrame: Baseline, 5 minutes post-intervention shift
measure: Change in STAI S-Anxiety
timeFrame: Baseline, 5 minutes post-intervention shift
measure: Change in STAI T-Anxiety
timeFrame: Baseline, 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Associate Professor of Emergency Medicine; Executive Director, Yale Center for Medical Simulation; Director, Resident Research
name: Leigh Evans, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Evans LV, Ray JM, Bonz JW, Joseph M, Gerwin JN, Dziura JD, Venkatesh AK, Wong AH. Improving patient and clinician safety during COVID-19 through rapidly adaptive simulation and a randomised controlled trial: a study protocol. BMJ Open. 2022 May 19;12(5):e058980. doi: 10.1136/bmjopen-2021-058980.