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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL157361 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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Approximately 300,000 Hispanic individuals experience respiratory failure each year in the U.S. Hispanic patients are twice as likely to die from respiratory failure as non-Hispanic patients. There is an urgent need to identify and remediate mechanisms that increase risk of death from respiratory failure. The team's preliminary work identified two potential mechanisms: Hispanic patients with respiratory failure are more likely to be deeply sedated and less likely to receive physical therapy than non-Hispanic patients, which are both associated with mortality and poor long-term functional outcomes. The overall objective of this proposal is to improve outcomes for patients with respiratory failure through changes in intensive care unit (ICU) practice. This trial will refine and pilot an intervention to promote guideline-concordant care. The team's preliminary intervention will be iteratively refined through patient, family, and clinician engagement and piloted at two U.S. ICUs. The outcome of this study will be an intervention aimed at reducing mortality from respiratory failure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Safer sedation bundle | Experimental | This is a unit-level quality improvement intervention to facilitate evidence-based sedation delivery. The quality improvement intervention consists of identification of a safe sedation champion among clinical staff, initiation of sedation rounds, and tools to facilitate structured assessment of sedation depth, delirium, and pain. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Safer sedation bundle | Other | This is a unit-level quality improvement intervention to facilitate evidence-based sedation delivery. The quality improvement intervention consists of identification of a safe sedation champion among clinical staff, initiation of sedation rounds, and tools to facilitate structured assessment of sedation depth, delirium, and pain. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility and acceptability | The co-primary endpoints are acceptability and feasibility. We will measure acceptability and feasibility in surveys using construct definitions from the Consolidated Framework for Implementation Research (CFIR) . | From enrollment to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient safety culture score | Measured using AHRQ's Survey on Patient Safety Culture. | Enrollment through 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Implementation barriers and facilitators | Measured using the 14-item pCAT brief quantitative assessment from the CFIR. | Enrollment through 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chelsea Chobany, MPH | Contact | 212-992-3723 | chelsea.chobany@nyu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mari Armstrong-Hough, PhD, MPH | New York University School of Global Public Health | Principal Investigator |
| Thomas Valley, MD, MSc | University of Colorado Anschutz School of Medicine | Principal Investigator |
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Small sample size may increase risk of identification if IPD are shared. We will defer to the IRB determination.
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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