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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Respiration, Artificial

Intervention / Treatment
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* Other: Telehealth- enabled support for SAT/SBT adherence
* Other: Usual audit and feedback for SAT/SBT adherence


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention 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<br>Usual audit and feedback + telehealth-enabled support | Other: Telehealth- enabled support for SAT/SBT adherence<br>* 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.<br>Other: Usual audit and feedback for SAT/SBT adherence<br>* Usual audit and feedback<br>|
| Active Comparator: Control - Usual audit/feedback for SAT/SBT adherence only<br>Usual audit and feedback | Other: Usual audit and feedback for SAT/SBT adherence<br>* Usual audit and feedback<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to C-SAT/SBT | 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 | ventilator-free days to day 28 | 28 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Invasive Mechanical Ventilation, Coordinated Spontaneous Awakening and Breathing Trials