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Promoting Change in Practice for Respiratory Failure

Promoting Change in Practice for Respiratory Failure: the PRECIPICE Study

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07519941
Acronym
PRECIPICE
Enrollment
20
Registered
2026-04-09
Start date
2026-08-01
Completion date
2027-04-01
Last updated
2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome (ARDS)

Brief 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.

Interventions

OTHERSafer 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.

Sponsors

New York University
Lead SponsorOTHER
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Feasibility and acceptabilityFrom enrollment to 3 monthsThe 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

MeasureTime frameDescription
Patient safety culture scoreEnrollment through 3 months.Measured using AHRQ's Survey on Patient Safety Culture.

Contacts

CONTACTChelsea Chobany, MPH
chelsea.chobany@nyu.edu212-992-3723
PRINCIPAL_INVESTIGATORMari Armstrong-Hough, PhD, MPH

New York University School of Global Public Health

PRINCIPAL_INVESTIGATORThomas Valley, MD, MSc

University of Colorado Anschutz School of Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 12, 2026