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The Patient and Family Centered I-PASS LISTEN Study: Language, Inclusion, Safety, and Teamwork for Equity Now
NCT05591066 · View on ClinicalTrials.gov ↗
Study Summary
In 2014, a team of parents, nurses, and physicians created Patient and Family Centered I-PASS (PFC I-PASS), a bundle of communication interventions to improve the quality of information exchange between physicians, nurses, and families, and to better integrate families into all aspects of daily decision making in hospitals. PFC I-PASS changed how doctors and nurses talk to patients and families on rounds when they're admitted to the hospital. (Rounds are when a team of doctors visit patients every morning to do a checkup and make a plan for the day.) Rounds used to happen in a way that left out patients and families. Doctors talked at, not with patients, used big words and medical talk, and left nurses out. PFC I-PASS changed rounds by including families and nurses, using simple non-medical words, and talking in an organized way so nothing is left out. When PFC I-PASS was put in place in 7 hospitals, patients had fewer adverse events and better hospital experience. But it didn't focus on how to talk with patients with language barriers. This project builds upon upon PFC I-PASS to make it better and focus on the special needs of patients who speak languages other than English. This new intervention is known as PFC I-PASS+. PFC I-PASS+ includes all parts of PFC I-PASS plus having interpreters on and after rounds and training doctors about communication and cultural humility. The study team will now conduct a stepped-wedge cluster randomized trial to compare the effectiveness of PFC I-PASS+ and PFC I-PASS to usual care at 8 hospitals.
Conditions Studied
Interventions
- BEHAVIORAL PFC I-PASS Intervention
- BEHAVIORAL PFC I-PASS+ Intervention
Study Locations (8)
California
- Children's Hospital Los Angeles — Los Angeles
- UCSF Benioff Children's Hospital of Oakland — Oakland
Alabama
- University of Alabama at Birmingham — Birmingham
Nebraska
- University of Nebraska Medical Center — Omaha
New York
- Children's Hospital at Montefiore — The Bronx
Ohio
- The Research Institute of Nationwide Children's Hospital — Columbus
Pennsylvania
- UPMC Children's Hospital of Pittsburgh — Pittsburgh
Texas
- Northwest Texas Healthcare System — Amarillo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14,400 participants |
| Start Date | 2024-03-26 |
| Est. Completion | 2028-11-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05591066
The ClinicalTrials.gov registry entry for NCT05591066 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 14,400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Children's Hospital, which has 752 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Communication appearing as the primary indexed condition, and to 2 interventions — of which PFC I-PASS Intervention is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05591066 reports 8 study locations spanning 7 distinct geographic areas — top geographies include California, Alabama, Nebraska. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05591066 about?
NCT05591066 is a clinical study titled "The Patient and Family Centered I-PASS LISTEN Study: Language, Inclusion, Safety, and Teamwork for Equity Now". In 2014, a team of parents, nurses, and physicians created Patient and Family Centered I-PASS (PFC I-PASS), a bundle of communication interventions to improve the quality of information exchange between physicians, nurses, and families, and to better integrate families into all aspects of daily deci...
What is the current status of trial NCT05591066?
This trial is currently recruiting. It is a NA study. The enrollment target is 14,400 participants. The study started on 2024-03-26. Estimated completion is 2028-11-01.
What conditions does trial NCT05591066 study?
This clinical trial studies the following conditions: Communication. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05591066?
The interventions under investigation include: PFC I-PASS Intervention (BEHAVIORAL), PFC I-PASS+ Intervention (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05591066?
This trial is sponsored by Boston Children's Hospital, which has 752 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05591066 being conducted?
This trial has 8 study locations across Alabama, California, Nebraska, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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