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

NCT ID: NCT03000829

Last Updated: 2024-05-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1001 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-12-31

Brief Summary

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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

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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").

Conditions

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Cardiac Arrest

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Tele-intensivist consultation

Intervention Type OTHER

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

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.

Group Type PLACEBO_COMPARATOR

Simulated "observation" by ICU physician

Intervention Type OTHER

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.

Interventions

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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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Are 18 years of age or older


* 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

* Are under 18 years of age
* Are a member of the study research team
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Intermountain Health Care, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ithan Peltan, MD

Role: PRINCIPAL_INVESTIGATOR

Intermountain Health Care, Inc.

Locations

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American Fork Hospital

American Fork, Utah, United States

Site Status

Intermountain Medical Center

Murray, Utah, United States

Site Status

The Orthopedic Specialty Hospital

Murray, Utah, United States

Site Status

McKay-Dee Hospital

Ogden, Utah, United States

Site Status

Park City Hospital

Park City, Utah, United States

Site Status

Riverton Hospital

Riverton, Utah, United States

Site Status

LDS Hospital

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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Spielberger CD, Gorsuch RL, Lushene R, Vagg PR, Jacobs GA. Manual for the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press; 1983.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 1393159 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22561464 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20117874 (View on PubMed)

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.

Reference Type RESULT
PMID: 35063451 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36214207 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1050317

Identifier Type: OTHER

Identifier Source: secondary_id

COPILOT-SIMULATION

Identifier Type: -

Identifier Source: org_study_id

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