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| ID | Type | Description | Link |
|---|---|---|---|
| U01HL159878 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Utah | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention - Telehealth- enabled support plus usual audit and feedback for SAT/SBT adherence | Experimental | Usual audit and feedback + telehealth-enabled support |
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| Control - Usual audit/feedback for SAT/SBT adherence only | Active Comparator | Usual audit and feedback |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telehealth- enabled support for SAT/SBT adherence | Other | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day Mortality | 30 days | |
| Hospital Length of Stay | Through hospital discharge, an average of 10 days | |
| 90-day Mortality |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carlos Barbagelata | Contact | 8015074607 | carlos.barbagelata@imail.org | |
| Colin Grissom, MD | Contact | 801-507-6554 | colin.grissom@imail.org |
| Name | Affiliation | Role |
|---|---|---|
| Colin Grissom, MD | Intermountain Health Care, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American Fork Hospital | Recruiting | American Fork | Utah | 84003 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37735443 | Derived | Grissom CK, Holubkov R, Carpenter L, Hanna B, Jacobs JR, Jones C, Knighton AJ, Leither L, Lisonbee D, Peltan ID, Winberg C, Wolfe D, Srivastava R. 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. Implement Sci. 2023 Sep 21;18(1):45. doi: 10.1186/s13012-023-01303-1. |
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In order to protect patient privacy and comply with relevant regulations, identified data will be unavailable. Requests for deidentified data from qualified researchers with appropriate ethics board approvals and relevant data use agreements will be processed by the Intermountain Office of Research, officeofresearch@imail.org.
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| Usual audit and feedback for SAT/SBT adherence | Other | Usual audit and feedback |
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| 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 |
| Cedar City Hospital | Recruiting | Cedar City | Utah | 84721 | United States |
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| Layton Hospital | Recruiting | Layton | Utah | 84041 | United States |
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| Logan Regional Hospital | Recruiting | Logan | Utah | 84341 | United States |
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| Intermountain Medical Center | Recruiting | Murray | Utah | 84107 | United States |
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| Mckay Dee Hospital | Recruiting | Ogden | Utah | 84403 | United States |
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| Utah Valley Hospital | Recruiting | Provo | Utah | 84604 | United States |
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| Riverton Hospital | Recruiting | Riverton | Utah | 84065 | United States |
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| LDS Hospital | Recruiting | Salt Lake City | Utah | 84143 | United States |
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| Alta View Hospital | Recruiting | Sandy City | Utah | 84094 | United States |
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| St. George Regional Hospital | Recruiting | St. George | Utah | 84790 | United States |
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| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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