Clinical trial NCT05141396: Telehealth-Enabled, Real-time Audit and Feedback for Clinician AdHerence (TEACH)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Respiration, Artificial
Keywords: Invasive Mechanical Ventilation
Coordinated Spontaneous Awakening and Breathing Trials
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
Collaborators: name: University of Utah
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-12-02
Enrollment: 13400
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adherence to C-SAT/SBT
timeFrame: intubation to extubation - an average of 5 days
measure: Ventilator-free days to day 28
timeFrame: 28 days
Secondary outcomes:
measure: 30-day Mortality
timeFrame: 30 days
measure: Hospital Length of Stay
timeFrame: Through hospital discharge, an average of 10 days
measure: 90-day Mortality
timeFrame: 90 Days
measure: New ventilator-associated pneumonia
timeFrame: Through hospital discharge, an average of 10 days
measure: ICU Length of Stay
timeFrame: Through hospital discharge, an average of 10 days
measure: Reintubation
timeFrame: intubation to extubation - an average of 5 days
measure: Unintentional Extubation
timeFrame: intubation to extubation - an average of 5 days
Other outcomes:
Locations:
city: American Fork
country: United States
facility: American Fork Hospital
state: Utah
city: Cedar City
country: United States
facility: Cedar City Hospital
state: Utah
city: Layton
country: United States
facility: Layton Hospital
state: Utah
city: Logan
country: United States
facility: Logan Regional Hospital
state: Utah
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Ogden
country: United States
facility: Mckay Dee Hospital
state: Utah
city: Provo
country: United States
facility: Utah Valley Hospital
state: Utah
city: Riverton
country: United States
facility: Riverton Hospital
state: Utah
city: Saint George
country: United States
facility: St. George Regional Hospital
state: Utah
city: Salt Lake City
country: United States
facility: LDS Hospital
state: Utah
city: Sandy
country: United States
facility: Alta View Hospital
state: Utah
Study officials:
affiliation: Intermountain Health Care, Inc.
name: Colin Grissom, MD
role: PRINCIPAL_INVESTIGATOR
References: