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Code Blue Outcomes & Process Improvement Through Leadership Optimization Using Teleintensivists-Simulation (COPILOT-Sim)

Primary Purpose

Cardiac Arrest

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tele-intensivist consultation
Simulated "observation" by ICU physician
Sponsored by
Intermountain Health Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cardiac Arrest focused on measuring Code blue, Code team, Crisis team leadership, Cardiopulmonary resuscitation, Telemedicine, Simulation, Mock code, In-hospital cardiac arrest

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria (on-site cardiac arrest team):

  • Are 18 years of age or older

Inclusion criteria (teleintensivist cardiac arrest team copilot):

  • Are 18 years of age or older
  • Are a board-certified or board-eligible critical care physician
  • Provide clinical care through the Intermountain Healthcare Telecritical Care program

Exclusion criteria (both groups):

  • Are under 18 years of age
  • Are a member of the study research team

Sites / Locations

  • American Fork Hospital
  • Intermountain Medical Center
  • The Orthopedic Specialty Hospital
  • McKay-Dee Hospital
  • Park City Hospital
  • Riverton Hospital
  • LDS Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tele-intensivist consultation

Control

Arm Description

Standardized consultation to on-site cardiac arrest response team by off-site intensivist via two-way audiovisual link using a mobile telemedicine cart

Simulated "observation" by ICU physician by displaying a silent, pre-recorded, non-interactive videotape of an ICU physician. The on-site participants will be told that an intensive care physician is observing the mock code.

Outcomes

Primary Outcome Measures

Fraction of pulseless time with no chest compressions

Secondary Outcome Measures

Time from onset of shockable rhythm to defibrillation
Fraction of chest compressions with complete release
Fraction of chest compressions at target rate
Time to first dose of epinephrine
Overall ACLS protocol adherence (using checklist adapted from McEvoy ACLS assessment tool)
ACLS protocol errors (using checklist adapted from McEvoy ACLS assessment tool)
Team Emergency Assessment Measure score
Types of input by telemedical intensivist copilot
Opinions of study subjects about experience participating in simulated cardiac arrest, using a locally-developed and validated survey instrument
Measured domains: understanding of telemedicine intensivist copilot's role, beliefs about telemedicine intensivist copilot's ability to integrate with on site team, ability to influence on-site team performance, comfort with telemedicine intensivist copilot's role, and function of telemedicine interface
Short form State-Trait Anxiety Inventory score
Presence of telemedicine audiovisual connection problems per intervention group simulation event

Full Information

First Posted
September 14, 2016
Last Updated
December 13, 2021
Sponsor
Intermountain Health Care, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03000829
Brief Title
Code Blue Outcomes & Process Improvement Through Leadership Optimization Using Teleintensivists-Simulation
Acronym
COPILOT-Sim
Official Title
Code Blue Outcomes & Process Improvement Through Leadership Optimization Using Teleintensivists-Simulation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intermountain Health Care, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This multicenter randomized trial will employ in-situ cardiac arrest simulations ("mock codes") to test whether using telemedicine technology to add an intensive care physician as the "copilot" for cardiac arrest resuscitation teams influences chest compression quality, resuscitation protocol adherence, team function, and provider experience.
Detailed Description
Only 15-30% of patients who suffer in-hospital cardiac arrest (IHCA) survive to hospital discharge. Factors associated with lower mortality and improved function include provision of high-quality, minimally-interrupted chest compressions and swift defibrillation of eligible arrhythmias. Unfortunately, resuscitation teams provide suboptimal care to 25-40% of IHCA victims. A dedicated IHCA team "copilot" may improve resuscitation team performance by providing the team leader with parallel analysis, situational awareness augmentation, action checking, protocol verification, and error correction. Critical care physician involvement via a telemedicine link could allow experienced specialists to fill the "copilot" role in a cost and resource-efficient manner, particularly in smaller hospitals with fewer available physicians. The current study will evaluate how consultation by an off-site intensive care physician via a telemedicine link influences local IHCA teams' quality of care, team function and provider experience during simulated cardiac arrest events ("mock codes").

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
Keywords
Code blue, Code team, Crisis team leadership, Cardiopulmonary resuscitation, Telemedicine, Simulation, Mock code, In-hospital cardiac arrest

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1001 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tele-intensivist consultation
Arm Type
Experimental
Arm Description
Standardized consultation to on-site cardiac arrest response team by off-site intensivist via two-way audiovisual link using a mobile telemedicine cart
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Simulated "observation" by ICU physician by displaying a silent, pre-recorded, non-interactive videotape of an ICU physician. The on-site participants will be told that an intensive care physician is observing the mock code.
Intervention Type
Other
Intervention Name(s)
Tele-intensivist consultation
Intervention Description
Standardized consultation to on-site cardiac arrest team by off-site intensivist via two-way audiovisual link using a mobile telemedicine cart
Intervention Type
Other
Intervention Name(s)
Simulated "observation" by ICU physician
Intervention Description
Display of silent, pre-recorded, non-interactive videotape of an ICU physician. The on-site cardiac arrest team will be told that an intensive care physician is observing the mock code.
Primary Outcome Measure Information:
Title
Fraction of pulseless time with no chest compressions
Time Frame
From initiation of intervention or placebo control until completion of two complete cycles of CPR (an average of 4 minutes)
Secondary Outcome Measure Information:
Title
Time from onset of shockable rhythm to defibrillation
Time Frame
From onset of simulated VF or VT until first defibrillation or end of simulation
Title
Fraction of chest compressions with complete release
Time Frame
From initiation of intervention or placebo control until completion of two complete cycles of CPR (an average of 4 minutes)
Title
Fraction of chest compressions at target rate
Time Frame
From initiation of intervention or placebo control until completion of two complete cycles of CPR (an average of 4 minutes)
Title
Time to first dose of epinephrine
Time Frame
From initiation of simulation through termination of simulation, an average of 15 minutes
Title
Overall ACLS protocol adherence (using checklist adapted from McEvoy ACLS assessment tool)
Time Frame
From initiation of simulation through termination of simulation, an average of 15 minutes
Title
ACLS protocol errors (using checklist adapted from McEvoy ACLS assessment tool)
Time Frame
From initiation of simulation through termination of simulation, an average of 15 minutes
Title
Team Emergency Assessment Measure score
Time Frame
From initiation of simulation through termination of simulation, an average of 15 minutes
Title
Types of input by telemedical intensivist copilot
Time Frame
From initiation of simulation through termination of simulation, an average of 15 minutes
Title
Opinions of study subjects about experience participating in simulated cardiac arrest, using a locally-developed and validated survey instrument
Description
Measured domains: understanding of telemedicine intensivist copilot's role, beliefs about telemedicine intensivist copilot's ability to integrate with on site team, ability to influence on-site team performance, comfort with telemedicine intensivist copilot's role, and function of telemedicine interface
Time Frame
Immediately after simulation
Title
Short form State-Trait Anxiety Inventory score
Time Frame
Immediately after simulation
Title
Presence of telemedicine audiovisual connection problems per intervention group simulation event
Time Frame
From initiation of simulation through termination of simulation, an average of 15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria (on-site cardiac arrest team): Are 18 years of age or older Inclusion criteria (teleintensivist cardiac arrest team copilot): Are 18 years of age or older Are a board-certified or board-eligible critical care physician Provide clinical care through the Intermountain Healthcare Telecritical Care program Exclusion criteria (both groups): Are under 18 years of age Are a member of the study research team
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ithan Peltan, MD
Organizational Affiliation
Intermountain Health Care, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
American Fork Hospital
City
American Fork
State/Province
Utah
ZIP/Postal Code
84003
Country
United States
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
The Orthopedic Specialty Hospital
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
McKay-Dee Hospital
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Park City Hospital
City
Park City
State/Province
Utah
ZIP/Postal Code
84060
Country
United States
Facility Name
Riverton Hospital
City
Riverton
State/Province
Utah
ZIP/Postal Code
84065
Country
United States
Facility Name
LDS Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized data will be available, after relevant IRB approval, by application to the principal investigator and Intermountain Office of Research.
Citations:
PubMed Identifier
36214207
Citation
Silva JAM, Mininel VA, Fernandes Agreli H, Peduzzi M, Harrison R, Xyrichis A. Collective leadership to improve professional practice, healthcare outcomes and staff well-being. Cochrane Database Syst Rev. 2022 Oct 10;10(10):CD013850. doi: 10.1002/14651858.CD013850.pub2.
Results Reference
derived
PubMed Identifier
35063451
Citation
Peltan ID, Guidry D, Brown K, Kumar N, Beninati W, Brown SM. Telemedical Intensivist Consultation During In-Hospital Cardiac Arrest Resuscitation: A Simulation-Based, Randomized Controlled Trial. Chest. 2022 Jul;162(1):111-119. doi: 10.1016/j.chest.2022.01.017. Epub 2022 Jan 19.
Results Reference
derived

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Code Blue Outcomes & Process Improvement Through Leadership Optimization Using Teleintensivists-Simulation

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