NCT03000829

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,001

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 22, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
5.5 years until next milestone

Results Posted

Study results publicly available

May 31, 2024

Completed
Last Updated

May 31, 2024

Status Verified

December 1, 2023

Enrollment Period

2 years

First QC Date

September 14, 2016

Results QC Date

January 27, 2022

Last Update Submit

December 14, 2023

Conditions

Cardiac Arrest

Keywords

Code blueCode teamCrisis team leadershipCardiopulmonary resuscitationTelemedicineSimulationMock codeIn-hospital cardiac arrest

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • 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

  • +6 more secondary outcomes

Study Arms (2)

Tele-intensivist consultation

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

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

Interventions

Tele-intensivist consultationOTHER

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

Tele-intensivist consultation
Simulated "observation" by ICU physicianOTHER

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.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

American Fork Hospital

American Fork, Utah, 84003, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

The Orthopedic Specialty Hospital

Murray, Utah, 84107, United States

Location

McKay-Dee Hospital

Ogden, Utah, 84403, United States

Location

Park City Hospital

Park City, Utah, 84060, United States

Location

Riverton Hospital

Riverton, Utah, 84065, United States

Location

LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

Related Publications (6)

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

    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.

    PMID: 1393159BACKGROUND

  • 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.

    PMID: 22561464BACKGROUND

  • 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.

    PMID: 20117874BACKGROUND

  • 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.

    PMID: 35063451RESULT

  • 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.

    PMID: 36214207DERIVED

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Dr. Ithan Peltan
Organization
Intermountain Health
ithan.peltan@imail.org
801-507-6556

Study Officials

  • Ithan Peltan, MD

    Intermountain Health Care, Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2016

First Posted

December 22, 2016

Study Start

December 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

May 31, 2024

Results First Posted

May 31, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will share

Anonymized data will be available, after relevant IRB approval, by application to the principal investigator and Intermountain Office of Research.

Locations

US(7)