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NCT Number: NCT05141396

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

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.

Recruiting

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

American Fork Hospital, American Fork, Utah, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telehealth- enabled support for SAT/SBT adherence

Other

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

Other

Usual audit and feedback

Primary outcomes

  1. 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.

  2. Ventilator-free days to day 28

    Time frame: 28 days

    ventilator-free days to day 28

Secondary outcomes

  1. 30-day Mortality

    Time frame: 30 days

  2. Hospital Length of Stay

    Time frame: Through hospital discharge, an average of 10 days

  3. 90-day Mortality

    Time frame: 90 Days

  4. New ventilator-associated pneumonia

    Time frame: Through hospital discharge, an average of 10 days

  5. ICU Length of Stay

    Time frame: Through hospital discharge, an average of 10 days

  6. Reintubation

    Time frame: intubation to extubation - an average of 5 days

  7. Unintentional Extubation

    Time frame: intubation to extubation - an average of 5 days

Study contacts

Contact information is provided by the study sponsor or research team.

Carlos Barbagelata

CONTACT

[email protected]

8015074607

Colin Grissom, MD

CONTACT

[email protected]

801-507-6554

Sponsors and collaborators

Lead sponsor

Intermountain Health Care, Inc.

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • University of Utah

Registry information

Official study 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

Acronym: TEACH

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Dec 2, 2021
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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