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NCT05591066 · ClinicalTrials.gov registry record · NA
The Patient and Family Centered I-PASS LISTEN Study: Language, Inclusion, Safety, and Teamwork for Equity Now
A NA study of Communication, sponsored by Boston Children's Hospital.
- Recruiting
- Registry status
- NA
- Development phase
- 14,400
- Enrollment target
- 8
- Study locations
NCT05591066: Recruiting NA study of Communication, sponsored by Boston Children's Hospital.
NCT05591066 is a NA study of Communication that is actively recruiting participants, run by Boston Children's Hospital. The registered enrollment target is 14,400 participants, above the 997-participant average among 34 other Communication trials with a reported enrollment target (1344% higher). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05591066, a NA study of Communication, is actively recruiting participants, sponsored by Boston Children's Hospital.
- RECRUITING
- Registry status
- NA
- Development phase
- 14,400 participants
- Enrollment target
- 8
- Study locations
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.
Primary Outcome
Chart review, self-reported by staff and patients/families, and hospital incident reports
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 |
What NCT05591066 shows while recruiting
NCT05591066 is an interventional study that assigns participants to a tested intervention. Its 14,400 participants enrollment target places it among the larger protocols in the corpus, above the 997-participant average among 34 other Communication trials with a reported enrollment target (1344% higher).
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.
NCT05591066 lists 8 locations in 7 states (California, Alabama, Nebraska).
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.
What interventions are being tested in trial NCT05591066?
The interventions under investigation include: PFC I-PASS Intervention (BEHAVIORAL), PFC I-PASS+ Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT05591066?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT05591066's enrollment target sits among peer trials
14,400 1st of 34 higher than 34 of 34 other Communication trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Communication trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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