Actively Recruiting

Phase Not Applicable
All Genders
NCT05591066

The Patient and Family Centered I-PASS LISTEN Study: Language, Inclusion, Safety, and Teamwork for Equity Now

Led by Boston Children's Hospital · Updated on 2025-06-24

14400

Participants Needed

8

Research Sites

240 weeks

Total Duration

On this page

Sponsors

B

Boston Children's Hospital

Lead Sponsor

P

Patient-Centered Outcomes Research Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

The Patient and Family Centered I-PASS LISTEN Study: Language, Inclusion, Safety, and Teamwork for Equity Now

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • All patients admitted to the pediatric inpatient study units of participating hospitals
  • Patients aged 13 and older who provide assent and whose parent or guardian gives permission
  • Parents or caregivers of patients of all ages who speak English, Arabic, Armenian, Bengali, Chinese (Mandarin and Cantonese), Karen, Korean, Nepali, Quiche, Spanish, Somali, or Vietnamese (and/or other languages if resources allow)
  • Nurses working on the pediatric inpatient units
  • Residents working on the pediatric inpatient units
  • Medical and nursing students working on the pediatric inpatient units
  • Hospital leaders working at the participating hospitals
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 8 locations

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35233

Actively Recruiting

2

Children's Hospital Los Angeles

Los Angeles, California, United States, 90027

Actively Recruiting

3

UCSF Benioff Children's Hospital of Oakland

Oakland, California, United States, 94609

Actively Recruiting

4

University of Nebraska Medical Center

Omaha, Nebraska, United States, 68198

Actively Recruiting

5

Children's Hospital at Montefiore

The Bronx, New York, United States, 10467

Actively Recruiting

6

The Research Institute of Nationwide Children's Hospital

Columbus, Ohio, United States, 43205

Actively Recruiting

7

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15224

Actively Recruiting

8

Northwest Texas Healthcare System

Amarillo, Texas, United States, 79106

Actively Recruiting

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Research Team

A

Alisa Khan, MD, MPH

CONTACT

E

Elizabeth Micolisin, BS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

3

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