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

NCT04614844 | Completed DMC

• 2 other identifiers: 20000293721R01HS028340-01
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

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

Conditions

Physician Stress Levels

Outcome Measures

Primary Outcomes (3)

• Change in end-of-shift heart rate variability

  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

  Baseline, 5 minutes post-intervention shift

• Change in STAI S-Anxiety

  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.

  Baseline, 5 minutes post-intervention shift

• Change in STAI T-Anxiety

  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.

  Baseline, 1 week

Study Arms (2)

Simulation Intervention

EXPERIMENTAL

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

Behavioral: Simulation Intervention

Control

ACTIVE COMPARATOR

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

Behavioral: Control

Interventions

Simulation Intervention BEHAVIORAL

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

Simulation Intervention

Control BEHAVIORAL

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Currently taking a beta-blocker and/or anti-arrhythmic medication
• Active (uncontrolled) thyroid dysfunction
• Pregnant

Sponsors & Collaborators

• Yale University: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06512, United States

Location

Related Publications (1)

• 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.

  PMID: 35589358 DERIVED

Study Officials

• Leigh Evans, MD

  Associate Professor of Emergency Medicine; Executive Director, Yale Center for Medical Simulation; Director, Resident Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 4, 2020
• Study Start: January 6, 2021
• Primary Completion: September 2, 2022
• Study Completion: September 2, 2022
• Last Updated: October 7, 2022

Record last verified: 2022-10

Locations

US (1)