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Randomized Controlled Trial
. 2023 Sep 21;18(1):45.
doi: 10.1186/s13012-023-01303-1.

Implementation of coordinated spontaneous awakening and breathing trials using telehealth-enabled, real-time audit and feedback for clinician adherence (TEACH): a type II hybrid effectiveness-implementation cluster-randomized trial

Colin K Grissom  1   2   3 , Richard Holubkov  4 , Lori Carpenter  5 , Bridgett Hanna  6 , Jason R Jacobs  7 , Christopher Jones  8 , Andrew J Knighton  6 , Lindsay Leither  7 , Dee Lisonbee  6 , Ithan D Peltan  7   9 , Carrie Winberg  5 , Doug Wolfe  6 , Rajendu Srivastava  6   10
Affiliations
Randomized Controlled Trial

Implementation of coordinated spontaneous awakening and breathing trials using telehealth-enabled, real-time audit and feedback for clinician adherence (TEACH): a type II hybrid effectiveness-implementation cluster-randomized trial

Colin K Grissom et al. Implement Sci. .

Abstract

Background: Intensive care unit (ICU) patients on mechanical ventilation often require sedation and analgesia to improve comfort and decrease pain. Prolonged sedation and analgesia, however, may increase time on mechanical ventilation, risk for ventilator associated pneumonia, and delirium. Coordinated interruptions in sedation [spontaneous awakening trials (SATs)] and spontaneous breathing trials (SBTs) increase ventilator-free days and improve mortality. Coordination of SATs and SBTs is difficult with substantial implementation barriers due to difficult-to-execute sequencing between nurses and respiratory therapists. Telehealth-enabled remote care has the potential to overcome these barriers and improve coordinated SAT and SBT adherence by enabling proactive high-risk patient monitoring, surveillance, and real-time assistance to frontline ICU teams.

Methods: The telehealth-enabled, real-time audit and feedback for clinician adherence (TEACH) study will determine whether adding a telehealth augmented real-time audit and feedback to a usual supervisor-led audit and feedback intervention will yield higher coordinated SAT and SBT adherence and more ventilator-free days in mechanically ventilated patients than a usual supervisor-led audit and feedback intervention alone in a type II hybrid effectiveness-implementation cluster-randomized clinical trial in 12 Intermountain Health hospitals with 15 ICUs. In the active comparator control group (six hospitals), the only intervention is the usual supervisor-led audit and feedback implementation. The telehealth-enabled support (TEACH) intervention in six hospitals adds real-time identification of patients eligible for a coordinated SAT and SBT and consultative input from telehealth respiratory therapists, nurses, and physicians to the bedside clinicians to promote adherence including real-time assistance with execution. All intubated and mechanically ventilated patients ≥ 16 years of age are eligible for enrollment except for patients who die on the day of intubation or have preexisting brain death. Based on preliminary power analyses, we plan a 36-month intervention period that includes a 90-day run-in period. Estimated enrollment in the final analysis is up to 9900 mechanically ventilated patients over 33 months.

Discussion: The TEACH study will enhance implementation science by providing insight into how a telehealth intervention augmenting a usual audit and feedback implementation may improve adherence to coordinated SAT and SBT and increase ventilator-free days.

Trial registration: Clinicaltrials.gov, NCT05141396 , registered 12/02/2021.

Keywords: Audit and feedback; Hybrid effectiveness-implementation trials; Implementation; Mechanical ventilation; Spontaneous awakening trials; Spontaneous breathing trials; Telehealth.

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Conflict of interest statement

IDP reports grants from the National Institutes of Health, Centers for Disease Control and Prevention, and Janssen Pharmaceuticals and funding to his institution from Regeneron and Asahi Kasei Pharma. RS reports grants from the National Institutes of Health, the Agency for Healthcare Research, the Centers for Disease Control and Prevention, and the Patient-Centered Research Outcomes Institute. RS is also a physician founder of the IPASS Patient Safety Institute, and his equity is owned by his employer, Intermountain Health. RH reports grants from the National Institutes of Health and consulting (DSMB member) for Pfizer. CKG report grants from the National Institutes of Health. Other authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Clinical trial diagram showing the measurement of baseline implementation and clinical effectiveness outcomes, randomization (R) of the 12 study hospitals to supervisor-led audit and feedback (6 hospitals) or supervisor-led audit and feedback plus the TEACH intervention (6 hospitals). The diagram also shows a future aim at the conclusion of the TEACH clinical trial that will evaluate sustainment in outcomes utilizing fewer resources in both the TEACH intervention and control arms
Fig. 2
Fig. 2
Algorithm for coordination of spontaneous awakening trials and spontaneous breathing trials color coded for nurse (light blue, RN), respiratory therapist (green, RT), and joint tasks (dark blue) including safety screens and failure criteria. MD is physician and APP is advanced practice provider
See this image and copyright information in PMC

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