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NCT Number: NCT07519941

Promoting Change in Practice for Respiratory Failure

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Feasibility and acceptability

    Time frame: 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

  1. Patient safety culture score

    Time frame: Enrollment through 3 months.

    Measured using AHRQ's Survey on Patient Safety Culture.

Other outcomes

  1. Implementation barriers and facilitators

    Time frame: Enrollment through 3 months

    Measured using the 14-item pCAT brief quantitative assessment from the CFIR.

Study contacts

Contact information is provided by the study sponsor or research team.

Chelsea Chobany, MPH

CONTACT

[email protected]

212-992-3723

Sponsors and collaborators

Lead sponsor

New York University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Promoting Change in Practice for Respiratory Failure: the PRECIPICE Study

Acronym: PRECIPICE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 9, 2026
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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