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Not yet recruiting NCT07519941

Promoting Change in Practice for Respiratory Failure

No phase Interventional Acute Respiratory Distress Syndrome (ARDS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Safer sedation bundle.
Who it may be relevant to
Registry conditions: Acute Respiratory Distress Syndrome (ARDS). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Promoting Change in Practice for Respiratory Failure: the PRECIPICE Study

Overview

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.

Interventions

  • Other Safer sedation bundle
    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.

Primary outcome measures

  • Feasibility and acceptability [Time frame: From enrollment to 3 months]
Secondary outcome measures (1)
  • Patient safety culture score [Time frame: Enrollment through 3 months.]

Eligibility criteria

Inclusion criteria

  • We will include physicians, nurses, and other staff at participating ICUs who consent to participate.

Exclusion criteria

  • We will exclude potential participants who cannot speak either English or Spanish.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07519941 · 1R01HL157361 · 1R01HL157361

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗