Promoting Change in Practice for Respiratory Failure

NCT07519941 — Not applicable, Not yet recruiting, 20 participants, New York University

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Promoting Change in Practice for Respiratory Failure: the PRECIPICE Study

Registry	NCT07519941, acronym PRECIPICE
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, health services research
Enrollment	20 (Estimated)
Sponsor	New York University (Other); collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions	Acute Respiratory Distress Syndrome (ARDS)
Interventions	Safer sedation bundle (Other)
Dates	start 2026-08-01 (estimated), primary completion 2027-04-01 (estimated), completion 2027-04-01 (estimated), first posted 2026-04-09, last updated 2026-05-11

-Summary

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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+Arms and interventions

Arm	Type	Interventions	Description
Safer sedation bundle	Experimental	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.

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.

+Outcome measures

Primary outcomes

Feasibility and acceptability [From enrollment to 3 months]: 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) .

Secondary outcomes

Patient safety culture score [Enrollment through 3 months.]: Measured using AHRQ's Survey on Patient Safety Culture.

Other outcomes

Implementation barriers and facilitators [Enrollment through 3 months]: Measured using the 14-item pCAT brief quantitative assessment from the CFIR.

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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.

+Investigators

Mari Armstrong-Hough, PhD, MPH, Principal investigator, New York University School of Global Public Health
Thomas Valley, MD, MSc, Principal investigator, University of Colorado Anschutz School of Medicine

+Funding

NIH grants: R01HL157361