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

Sponsor

Intermountain Health Care, Inc. (Other)

Overall Status

Completed

CT.gov ID

NCT03000829

Collaborator

(none)

1,001

Enrollment

Locations

Arms

Duration (Months)

143

Patients Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Arrest	Other: Tele-intensivist consultation Other: Simulated "observation" by ICU physician	N/A

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").

Study Design

Study Type:

Interventional

Actual Enrollment :

1001 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Study Start Date :

Dec 1, 2016

Actual Primary Completion Date :

Dec 1, 2018

Actual Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tele-intensivist consultation Standardized consultation to on-site cardiac arrest response team by off-site intensivist via two-way audiovisual link using a mobile telemedicine cart	Other: Tele-intensivist consultation Standardized consultation to on-site cardiac arrest team by off-site intensivist via two-way audiovisual link using a mobile telemedicine cart
Placebo Comparator: Control 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.	Other: Simulated "observation" by ICU physician 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.

Arm

Intervention/Treatment

Experimental: Tele-intensivist consultation

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

Other: Tele-intensivist consultation

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

Placebo Comparator: Control

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.

Other: Simulated "observation" by ICU physician

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.

Outcome Measures

Primary Outcome Measures

Fraction of pulseless time with no chest compressions [From initiation of intervention or placebo control until completion of two complete cycles of CPR (an average of 4 minutes)]

Secondary Outcome Measures

Time from onset of shockable rhythm to defibrillation [From onset of simulated VF or VT until first defibrillation or end of simulation]
Fraction of chest compressions with complete release [From initiation of intervention or placebo control until completion of two complete cycles of CPR (an average of 4 minutes)]
Fraction of chest compressions at target rate [From initiation of intervention or placebo control until completion of two complete cycles of CPR (an average of 4 minutes)]
Time to first dose of epinephrine [From initiation of simulation through termination of simulation, an average of 15 minutes]
Overall ACLS protocol adherence (using checklist adapted from McEvoy ACLS assessment tool) [From initiation of simulation through termination of simulation, an average of 15 minutes]
ACLS protocol errors (using checklist adapted from McEvoy ACLS assessment tool) [From initiation of simulation through termination of simulation, an average of 15 minutes]
Team Emergency Assessment Measure score [From initiation of simulation through termination of simulation, an average of 15 minutes]
Types of input by telemedical intensivist copilot [From initiation of simulation through termination of simulation, an average of 15 minutes]
Opinions of study subjects about experience participating in simulated cardiac arrest, using a locally-developed and validated survey instrument [Immediately after simulation]
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 [Immediately after simulation]
Presence of telemedicine audiovisual connection problems per intervention group simulation event [From initiation of simulation through termination of simulation, an average of 15 minutes]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	American Fork Hospital	American Fork	Utah	United States	84003
2	Intermountain Medical Center	Murray	Utah	United States	84107
3	The Orthopedic Specialty Hospital	Murray	Utah	United States	84107
4	McKay-Dee Hospital	Ogden	Utah	United States	84403
5	Park City Hospital	Park City	Utah	United States	84060
6	Riverton Hospital	Riverton	Utah	United States	84065
7	LDS Hospital	Salt Lake City	Utah	United States	84143