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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03000829
Other study ID # COPILOT-SIMULATION
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2016
Est. completion date December 2018

Study information

Verified date December 2021
Source Intermountain Health Care, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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").


Recruitment information / eligibility

Status Completed
Enrollment 1001
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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
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.

Locations

Country Name City State
United States American Fork Hospital American Fork Utah
United States Intermountain Medical Center Murray Utah
United States The Orthopedic Specialty Hospital Murray Utah
United States McKay-Dee Hospital Ogden Utah
United States Park City Hospital Park City Utah
United States Riverton Hospital Riverton Utah
United States LDS Hospital Salt Lake City Utah

Sponsors (1)

Lead Sponsor Collaborator
Intermountain Health Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Time from onset of shockable rhythm to defibrillation From onset of simulated VF or VT until first defibrillation or end of simulation
Secondary 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)
Secondary 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)
Secondary Time to first dose of epinephrine From initiation of simulation through termination of simulation, an average of 15 minutes
Secondary 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
Secondary ACLS protocol errors (using checklist adapted from McEvoy ACLS assessment tool) From initiation of simulation through termination of simulation, an average of 15 minutes
Secondary Team Emergency Assessment Measure score From initiation of simulation through termination of simulation, an average of 15 minutes
Secondary Types of input by telemedical intensivist copilot From initiation of simulation through termination of simulation, an average of 15 minutes
Secondary 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 Immediately after simulation
Secondary Short form State-Trait Anxiety Inventory score Immediately after simulation
Secondary Presence of telemedicine audiovisual connection problems per intervention group simulation event From initiation of simulation through termination of simulation, an average of 15 minutes
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