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COVID-19 Responsive Intervention: Systems Improvement Simulations (CRI:SIS)

NCT04614844 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2022-10-07

No results posted yet for this study

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

Conditions

  • Physician Stress Levels

Interventions

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.

Sponsors & Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

    collaborator FED

  • Yale University

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-06
Primary Completion
2022-09-02
Completion
2022-09-02

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04614844 on ClinicalTrials.gov