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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Intermountain Health Care, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)
University of Utah

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 2, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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