Purpose

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

Eligibility

Eligible Ages
Over 16 Years
Eligible Sex
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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Health Services Research
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

American Fork Hospital
American Fork, Utah 84003
Contact:
David Guidry, MD

Cedar City Hospital
Cedar City, Utah 84721
Contact:
David Guidry, MD

Layton Hospital
Layton, Utah 84041
Contact:
David Guidry, MD

Logan Regional Hospital
Logan, Utah 84341
Contact:
David Guidry, MD

Intermountain Medical Center
Murray, Utah 84107
Contact:
Andrew Knighton
801-507-8714
Andrew.Knighton@imail.org

Mckay Dee Hospital
Ogden, Utah 84403
Contact:
Colin Grissom, MD

Utah Valley Hospital
Provo, Utah 84604
Contact:
Colin Grissom, MD

Riverton Hospital
Riverton, Utah 84065
Contact:
David Guidry, MD

LDS Hospital
Salt Lake City, Utah 84143
Contact:
Colin Grissom, MD

Alta View Hospital
Sandy City, Utah 84094
Contact:
David Guidry, MD

St. George Regional Hospital
St. George, Utah 84790
Contact:
Colin Grissom, MD

More Details

NCT ID
NCT05141396
Status
Recruiting
Sponsor
Intermountain Health Care, Inc.

Study Contact

Carlos Barbagelata
8015074607
carlos.barbagelata@imail.org

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.