Promoting Change in Practice for Respiratory Failure

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNew York University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Safer sedation bundle

    Other intervention

    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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Safer sedation bundleExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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) .

Time frame
From enrollment to 3 months

Secondary outcomes

1

Patient safety culture score

Measured using AHRQ's Survey on Patient Safety Culture.

Time frame
Enrollment through 3 months.

Other outcomes

1

Implementation barriers and facilitators

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

Time frame
Enrollment through 3 months

Locations

This trial has no locations.

Sponsors and contacts

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New York University

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: