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

Sponsor
Intermountain Health Care, Inc. (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05141396
Collaborator
University of Utah (Other), National Heart, Lung, and Blood Institute (NHLBI) (NIH)
13,400
11
2
33.4
1218.2
36.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Telehealth- enabled support for SAT/SBT adherence
  • Other: Usual audit and feedback for SAT/SBT adherence
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
13400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
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
Anticipated Study Start Date :
Jan 1, 2024
Anticipated Primary Completion Date :
Aug 31, 2026
Anticipated Study Completion Date :
Oct 15, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Adherence to C-SAT/SBT [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 [28 days]

    ventilator-free days to day 28

Secondary Outcome Measures

  1. 30-day Mortality [30 days]

  2. Hospital Length of Stay [Through hospital discharge, an average of 10 days]

  3. 90-day Mortality [90 Days]

  4. New ventilator-associated pneumonia [Through hospital discharge, an average of 10 days]

  5. ICU Length of Stay [Through hospital discharge, an average of 10 days]

  6. Reintubation [intubation to extubation - an average of 5 days]

  7. Unintentional Extubation [intubation to extubation - an average of 5 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 American Fork Hospital American Fork Utah United States 84003
2 Cedar City Hospital Cedar City Utah United States 84721
3 Layton Hospital Layton Utah United States 84041
4 Logan Regional Hospital Logan Utah United States 84341
5 Intermountain Medical Center Murray Utah United States 84107
6 Mckay Dee Hospital Ogden Utah United States 84403
7 Utah Valley Hospital Provo Utah United States 84604
8 Riverton Hospital Riverton Utah United States 84065
9 St. George Regional Hospital Saint George Utah United States 84790
10 LDS Hospital Salt Lake City Utah United States 84143
11 Alta View Hospital Sandy Utah United States 84094

Sponsors and Collaborators

  • Intermountain Health Care, Inc.
  • University of Utah
  • National Heart, Lung, and Blood Institute (NHLBI)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier:
NCT05141396
Other Study ID Numbers:
  • 1051681
  • U01HL159878
First Posted:
Dec 2, 2021
Last Update Posted:
Aug 2, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Intermountain Health Care, Inc.

Study Results

No Results Posted as of Aug 2, 2022