Completed

NCT Number: NCT04614844

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

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

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Key information

Conditions

Physician Stress Levels

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale New Haven Hospital

New Haven, Connecticut, 06512, United States

About this study

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:

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Simulation Intervention

Behavioral

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

Control

Behavioral

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

Primary outcomes

Change in end-of-shift heart rate variability

Time frame: Baseline, 5 minutes post-intervention shift

The change in physician end-of-shift heart rate variability will be measured using the Hexoskin Smart Shirt.

Changes in HRV will be averaged over the two post-intervention shift data collections to control for an anticipated shift-to-shift and patient-to-patient variability in stress response due to patient acuity and workload
Change in STAI S-Anxiety

Time frame: Baseline, 5 minutes post-intervention shift

The change in physician end-of-shift anxiety measured by the State-Trait Anxiety Inventory (STAI) for physicians exposed to the simulation based training preparation compared to standard guideline update delivery. Each STAI item is given a weighted score of 1 to 4. A rating of 4 indicates the presence of a high level of anxiety for items (e.g., "I feel frightened," "I feel upset"). To obtain scores for the S-Anxiety, simply add the weighted scores for the twenty items that make up the scale, taking into account the fact that the scores are reversed for specific items. Scores for the S-Anxiety scale can vary from a minimum of 20 to a maximum of 80.
Change in STAI T-Anxiety

Time frame: Baseline, 1 week

The secondary outcome of interest is change in anxiety between the intervention and control conditions as measured by the State-Trait Anxiety Inventory (STAI). The T-Anxiety scale (STAI Form Y-2) consists of twenty statements that assess how people generally feel. The scoring weights for the anxiety-present items are the same as the chosen numbers on the print inventory form. To obtain scores for the T-Anxiety scale, simply add the weighted scores for the twenty items that make up the scale, taking into account the fact that the scores are reversed for specific items. Scores for the T- Anxiety scales can vary from a minimum of 20 to a maximum of 80.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

Agency for Healthcare Research and Quality (AHRQ)

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Nov 4, 2020
Registry last updated: Oct 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.