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

June 29, 2023 updated by: Intermountain Health Care, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

13400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Utah
      • American Fork, Utah, United States, 84003
        • Recruiting
        • American Fork Hospital
        • Contact:
          • David Guidry, MD
        • Principal Investigator:
          • David Guidry, MD
      • Cedar City, Utah, United States, 84721
        • Recruiting
        • Cedar City Hospital
        • Contact:
          • David Guidry, MD
        • Principal Investigator:
          • David Guidry, MD
      • Layton, Utah, United States, 84041
        • Recruiting
        • Layton Hospital
        • Contact:
          • David Guidry, MD
        • Principal Investigator:
          • David Guidry, MD
      • Logan, Utah, United States, 84341
        • Recruiting
        • Logan Regional Hospital
        • Contact:
          • David Guidry, MD
        • Principal Investigator:
          • David Guidry, MD
      • Murray, Utah, United States, 84107
        • Recruiting
        • Intermountain Medical Center
        • Sub-Investigator:
          • Ithan Peltan, MD
        • Contact:
        • Principal Investigator:
          • Colin Grissom, MD
        • Sub-Investigator:
          • Samuel Brown, MD
        • Sub-Investigator:
          • Perry Gee, MD
        • Sub-Investigator:
          • David Guidry
        • Sub-Investigator:
          • Andrew Knighton
        • Sub-Investigator:
          • Lindsay Leither, DO
        • Sub-Investigator:
          • Pallavi Ranade
        • Sub-Investigator:
          • Rajendu Srivastava
      • Ogden, Utah, United States, 84403
        • Recruiting
        • Mckay Dee Hospital
        • Principal Investigator:
          • Colin Grissom, MD
        • Contact:
          • Colin Grissom, MD
      • Provo, Utah, United States, 84604
        • Recruiting
        • Utah Valley Hospital
        • Principal Investigator:
          • Colin Grissom, MD
        • Contact:
          • Colin Grissom, MD
      • Riverton, Utah, United States, 84065
        • Recruiting
        • Riverton Hospital
        • Contact:
          • David Guidry, MD
        • Principal Investigator:
          • David Guidry, MD
      • Saint George, Utah, United States, 84790
        • Recruiting
        • St. George Regional Hospital
        • Principal Investigator:
          • Colin Grissom, MD
        • Contact:
          • Colin Grissom, MD
      • Salt Lake City, Utah, United States, 84143
        • Recruiting
        • LDS Hospital
        • Principal Investigator:
          • Colin Grissom, MD
        • Contact:
          • Colin Grissom, MD
      • Sandy, Utah, United States, 84094
        • Recruiting
        • Alta View Hospital
        • Contact:
          • David Guidry, MD
        • Principal Investigator:
          • David Guidry, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention - Telehealth- enabled support plus usual audit and feedback for SAT/SBT adherence
Usual audit and feedback + telehealth-enabled support
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
Active Comparator: Control - Usual audit/feedback for SAT/SBT adherence only
Usual audit and feedback
Other: Usual audit and feedback for SAT/SBT adherence
Usual audit and feedback

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
intubation to extubation - an average of 5 days
Ventilator-free days to day 28
Time Frame: 28 days
ventilator-free days to day 28
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
30-day Mortality
Time Frame: 30 days
30 days
Hospital Length of Stay
Time Frame: Through hospital discharge, an average of 10 days
Through hospital discharge, an average of 10 days
90-day Mortality
Time Frame: 90 Days
90 Days
New ventilator-associated pneumonia
Time Frame: Through hospital discharge, an average of 10 days
Through hospital discharge, an average of 10 days
ICU Length of Stay
Time Frame: Through hospital discharge, an average of 10 days
Through hospital discharge, an average of 10 days
Reintubation
Time Frame: intubation to extubation - an average of 5 days
intubation to extubation - an average of 5 days
Unintentional Extubation
Time Frame: intubation to extubation - an average of 5 days
intubation to extubation - an average of 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intermountain Health Care, Inc.

Collaborators

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

Investigators

  • Principal Investigator: Colin Grissom, MD, Intermountain Health Care, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

October 15, 2026

Study Registration Dates

First Submitted

November 19, 2021

First Submitted That Met QC Criteria

November 19, 2021

First Posted (Actual)

December 2, 2021

Study Record Updates

Last Update Posted (Actual)

July 3, 2023

Last Update Submitted That Met QC Criteria

June 29, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1051681
  • U01HL159878 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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