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Trial record 8 of 61 for:    TEACH | mechanical ventilation
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Telehealth-Enabled, Real-time Audit and Feedback for Clinician AdHerence (TEACH) (TEACH)

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ClinicalTrials.gov Identifier: NCT05141396
Recruitment Status : Recruiting
First Posted : December 2, 2021
Last Update Posted : July 3, 2023
Sponsor:
Collaborators:
University of Utah
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Intermountain Health Care, Inc.

Tracking Information
First Submitted Date  ICMJE November 19, 2021
First Posted Date  ICMJE December 2, 2021
Last Update Posted Date July 3, 2023
Actual Study Start Date  ICMJE September 1, 2022
Estimated Primary Completion Date August 31, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2021)
  • Adherence to C-SAT/SBT [ Time Frame: intubation to extubation - an average of 5 days ]
    Fraction of eligible days on which coordinated spontaneous awakening trial and spontaneous breathing trial completed.
  • Ventilator-free days to day 28 [ Time Frame: 28 days ]
    ventilator-free days to day 28
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2021)
  • 30-day Mortality [ Time Frame: 30 days ]
  • Hospital Length of Stay [ Time Frame: Through hospital discharge, an average of 10 days ]
  • 90-day Mortality [ Time Frame: 90 Days ]
  • New ventilator-associated pneumonia [ Time Frame: Through hospital discharge, an average of 10 days ]
  • ICU Length of Stay [ Time Frame: Through hospital discharge, an average of 10 days ]
  • Reintubation [ Time Frame: intubation to extubation - an average of 5 days ]
  • Unintentional Extubation [ Time Frame: intubation to extubation - an average of 5 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Telehealth-Enabled, Real-time Audit and Feedback for Clinician AdHerence (TEACH)
Official Title  ICMJE Implementation of Coordinated Spontaneous Awakening and Breathing Trials Using Telehealth-Enabled, Real-Time Audit and Feedback for Clinician Adherence: A Type II Hybrid Effectiveness-Implementation
Brief Summary The purpose of this trial is to evaluate if augmenting a usual audit and feedback implementation approach with telehealth-enabled support improves coordinated spontaneous awakening/breathing trials and patient outcomes for mechanically ventilated patients.
Detailed Description Sedation and analgesia are utilized with invasive mechanical ventilation (IMV) to improve patient comfort and synchrony with the mechanical ventilator. Prolonged sedation, however, may result in increased time on IMV and increased risk for ventilator associated pneumonia, delirium, and poor long-term cognitive outcomes. Daily interruptions in sedation [spontaneous awakening trials (SAT)] coordinated with daily spontaneous breathing trials (SBT) reduce mortality, increase ventilator free days, decrease intensive care unit (ICU) length of stay, and reduces ventilator-associated events. Coordination of spontaneous awakening and breathing trials (C-SAT/SBT), however, are underutilized due to significant barriers to implementation and adherence. This cluster-randomized hybrid implementation/effectiveness trial will compare C-SAT/SBT adherence and clinical outcomes in the presence of traditional audit and feedback implementation strategies alone or augmented with a novel Telehealth-Enabled, real-time Audit and feedback for Clinician adHerence ("TEACH") implementation strategy.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Respiration, Artificial
Intervention  ICMJE
  • Other: Telehealth- enabled support for SAT/SBT adherence
    Telehealth-enabled support over and above usual audit and feedback includes identifying candidates for spontaneous awakening and breathing trials, prompting bedside providers and guiding execution of the coordinated spontaneous awakening and breathing trials as needed.
  • Other: Usual audit and feedback for SAT/SBT adherence
    Usual audit and feedback
Study Arms  ICMJE
  • Experimental: Intervention - Telehealth- enabled support plus usual audit and feedback for SAT/SBT adherence
    Usual audit and feedback + telehealth-enabled support
    Interventions:
    • Other: Telehealth- enabled support for SAT/SBT adherence
    • Other: Usual audit and feedback for SAT/SBT adherence
  • Active Comparator: Control - Usual audit/feedback for SAT/SBT adherence only
    Usual audit and feedback
    Intervention: Other: Usual audit and feedback for SAT/SBT adherence
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 19, 2021)		 13400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 15, 2026
Estimated Primary Completion Date August 31, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Patient age >=16 years admitted to study hospital ICU
  • Intubated and mechanically ventilated

Exclusion criteria:

  • Patient with pre-existing brain death admitted to study hospital for organ donation
  • Died within 24 hours of intubation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Carlos Barbagelata 8015074607 carlos.barbagelata@imail.org
Contact: Colin Grissom, MD 801-507-6554 colin.grissom@imail.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05141396
Other Study ID Numbers  ICMJE 1051681
U01HL159878 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: In order to protect patient privacy and comply with relevant regulations, identified data will be unavailable. Requests for deidentified data from qualified researchers with appropriate ethics board approvals and relevant data use agreements will be processed by the Intermountain Office of Research, officeofresearch@imail.org.
Current Responsible Party Intermountain Health Care, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Intermountain Health Care, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • University of Utah
  • National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Colin Grissom, MD Intermountain Health Care, Inc.
PRS Account Intermountain Health Care, Inc.
Verification Date June 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP