Clinical trial NCT03000829: Code Blue Outcomes & Process Improvement Through Leadership Optimization Using Teleintensivists-Simulation
Official title: Code Blue Outcomes & Process Improvement Through Leadership Optimization Using Teleintensivists-Simulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest
Keywords: Code blue
Code team
Crisis team leadership
Cardiopulmonary resuscitation
Telemedicine
Simulation
Mock code
In-hospital cardiac arrest
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
First posted: 2016-12-22
Enrollment: 1001
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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").

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

Primary outcomes:
measure: Fraction of Pulseless Time With no Chest Compressions
timeFrame: From initiation of intervention or placebo control until completion of two complete cycles of CPR (an average of 4 minutes)
Secondary outcomes:
measure: Time From Onset of Shockable Rhythm to Defibrillation
timeFrame: From onset of simulated VF or VT until first defibrillation or end of simulation
measure: Fraction of Chest Compressions With Complete Release
timeFrame: From initiation of intervention or placebo control until completion of two complete cycles of CPR (an average of 4 minutes)
measure: Fraction of Chest Compressions at Target Rate
timeFrame: From initiation of intervention or placebo control until completion of two complete cycles of CPR (an average of 4 minutes)
measure: Time to First Dose of Epinephrine
timeFrame: From initiation of simulation through termination of simulation, an average of 15 minutes
measure: Overall ACLS Protocol Adherence (Using Checklist Adapted From McEvoy ACLS Assessment Tool)
timeFrame: From initiation of simulation through termination of simulation, an average of 15 minutes
measure: ACLS Protocol Errors (Using Checklist Adapted From McEvoy ACLS Assessment Tool)
timeFrame: From initiation of simulation through termination of simulation, an average of 15 minutes
measure: Team Emergency Assessment Measure Score
timeFrame: From initiation of simulation through termination of simulation, an average of 15 minutes
measure: Types of Input by Telemedical Intensivist Copilot
timeFrame: From initiation of simulation through termination of simulation, an average of 15 minutes
measure: Opinions of Study Subjects About Experience Participating in Simulated Cardiac Arrest, Using a Locally-developed and Validated Survey Instrument
timeFrame: Immediately after simulation
measure: Short-form State-Trait Anxiety Inventory Score
timeFrame: Immediately after simulation
measure: Presence of Telemedicine Audiovisual Connection Problems for Intervention Group Simulation Event
timeFrame: From initiation of simulation through termination of simulation, an average of 15 minutes
Other outcomes:
Locations:
city: American Fork
country: United States
facility: American Fork Hospital
state: Utah
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Murray
country: United States
facility: The Orthopedic Specialty Hospital
state: Utah
city: Ogden
country: United States
facility: McKay-Dee Hospital
state: Utah
city: Park City
country: United States
facility: Park City Hospital
state: Utah
city: Riverton
country: United States
facility: Riverton Hospital
state: Utah
city: Salt Lake City
country: United States
facility: LDS Hospital
state: Utah
Study officials:
affiliation: Intermountain Health Care, Inc.
name: Ithan Peltan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spielberger CD, Gorsuch RL, Lushene R, Vagg PR, Jacobs GA. Manual for the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press; 1983.
citation: Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI). Br J Clin Psychol. 1992 Sep;31(3):301-6. doi: 10.1111/j.2044-8260.1992.tb00997.x.
citation: McKay A, Walker ST, Brett SJ, Vincent C, Sevdalis N. Team performance in resuscitation teams: comparison and critique of two recently developed scoring tools. Resuscitation. 2012 Dec;83(12):1478-83. doi: 10.1016/j.resuscitation.2012.04.015. Epub 2012 May 3.
citation: Cooper S, Cant R, Porter J, Sellick K, Somers G, Kinsman L, Nestel D. Rating medical emergency teamwork performance: development of the Team Emergency Assessment Measure (TEAM). Resuscitation. 2010 Apr;81(4):446-52. doi: 10.1016/j.resuscitation.2009.11.027. Epub 2010 Feb 1.
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.
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.