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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-06

Study Completion Date

2022-09-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparative Effectiveness of Telemedicine in Primary Care

NCT04684836

Asthma Chronic Obstructive Pulmonary Disease (COPD) Congestive Heart Failure +2 more

COMPLETED

AR vs In Person Simulation for Medical Workplace Training

NCT05674188

Augmented Reality

COMPLETED NA

A Pilot Study of Changing Medication Adherence In Hypertensive African-American Patients

NCT00248937

Hypertension

COMPLETED NA

Cardiovascular Intervention Improvement Telemedicine Study

NCT01142908

Cardiovascular Disease Hypertension Diabetes +1 more

COMPLETED NA

Piloting IVR (Interactive Voice Response) for Chronic Pain Treatment

NCT00651924

Chronic Pain

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Physician Stress Levels

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Simulation Intervention

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

Group Type EXPERIMENTAL

Simulation Intervention

Intervention Type BEHAVIORAL

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

Control

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

Group Type ACTIVE_COMPARATOR

Control

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Simulation Intervention

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

Intervention Type BEHAVIORAL

Control

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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