Telehealth support for improving care in mechanically ventilated patients
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
This study tests if adding telehealth support to regular care can help patients on ventilators wake up and breathe better, reducing risks from long-term sedation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 13400 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Intermountain Health Care, Inc. Academic / other |
| Locations | 11 sites (American Fork, Utah and 10 other locations) |
| Trial ID | NCT05141396 on ClinicalTrials.gov |
What this trial studies
This trial evaluates whether adding telehealth-enabled support to traditional audit and feedback methods can enhance adherence to coordinated spontaneous awakening and breathing trials for patients on invasive mechanical ventilation. The study aims to address the challenges of prolonged sedation and its associated risks by implementing a novel approach that promotes daily interruptions in sedation and breathing trials. By comparing outcomes between standard practices and the augmented telehealth approach, the trial seeks to improve patient outcomes and reduce complications related to mechanical ventilation.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 16 and older who are intubated and mechanically ventilated in the ICU.
Not a fit: Patients who are brain dead upon admission or who die within 24 hours of intubation will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better patient outcomes, including reduced ICU length of stay and lower rates of ventilator-associated complications.
How similar studies have performed: Previous studies have shown that coordinated awakening and breathing trials can improve outcomes, but the telehealth-enabled approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
American Fork, Utah and 10 other locations
- American Fork Hospital — American Fork, Utah, United States (Recruiting)
- Cedar City Hospital — Cedar City, Utah, United States (Recruiting)
- Layton Hospital — Layton, Utah, United States (Recruiting)
- Logan Regional Hospital — Logan, Utah, United States (Recruiting)
- Intermountain Medical Center — Murray, Utah, United States (Recruiting)
- Mckay Dee Hospital — Ogden, Utah, United States (Recruiting)
- Utah Valley Hospital — Provo, Utah, United States (Recruiting)
- Riverton Hospital — Riverton, Utah, United States (Recruiting)
- LDS Hospital — Salt Lake City, Utah, United States (Recruiting)
- Alta View Hospital — Sandy City, Utah, United States (Recruiting)
- St. George Regional Hospital — St. George, Utah, United States (Recruiting)
Study contacts
- Principal investigator: Colin Grissom, MD — Intermountain Health Care, Inc.
- Study coordinator: Carlos Barbagelata
- Email: carlos.barbagelata@imail.org
- Phone: 8015074607
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.