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NCT05141396 Clinical Trial

Telehealth-Enabled, Real-time Audit and Feedback for Clinician AdHerence (TEACH)

Respiration, Artificial Clinical Trial

— TEACH  

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05141396
Other study ID # 1051681
Secondary ID U01HL159878
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date October 15, 2026

Study information
Verified date June 2023
Source Intermountain Health Care, Inc.
Contact Carlos Barbagelata
Phone 8015074607
Email carlos.barbagelata@imail.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 13400
Est. completion date October 15, 2026
Est. primary completion date August 31, 2026
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.
• Usual audit and feedback for SAT/SBT adherence
Usual audit and feedback

Locations
Country Name City State
United States American Fork Hospital American Fork Utah
United States Cedar City Hospital Cedar City Utah
United States Layton Hospital Layton Utah
United States Logan Regional Hospital Logan Utah
United States Intermountain Medical Center Murray Utah
United States Mckay Dee Hospital Ogden Utah
United States Utah Valley Hospital Provo Utah
United States Riverton Hospital Riverton Utah
United States St. George Regional Hospital Saint George Utah
United States LDS Hospital Salt Lake City Utah
United States Alta View Hospital Sandy Utah

Sponsors (3)
Lead Sponsor Collaborator
Intermountain Health Care, Inc. National Heart, Lung, and Blood Institute (NHLBI), University of Utah

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adherence to C-SAT/SBT Fraction of eligible days on which coordinated spontaneous awakening trial and spontaneous breathing trial completed. intubation to extubation - an average of 5 days
Primary Ventilator-free days to day 28 ventilator-free days to day 28 28 days
Secondary 30-day Mortality 30 days
Secondary Hospital Length of Stay Through hospital discharge, an average of 10 days
Secondary 90-day Mortality 90 Days
Secondary New ventilator-associated pneumonia Through hospital discharge, an average of 10 days
Secondary ICU Length of Stay Through hospital discharge, an average of 10 days
Secondary Reintubation intubation to extubation - an average of 5 days
Secondary Unintentional Extubation intubation to extubation - an average of 5 days
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