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

Recruiting now · Not applicable

Conditions studied: Communication

In brief

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.

Key facts

Study ID: NCT05591066
Run by: Boston Children's Hospital
People needed: 14400
Starts: 2024-03-26
Expected to finish: 2028-11-01
Last updated by the study team: 2025-06-24

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

All patients admitted to the pediatric inpatient study units of participating hospitals
Patients themselves who are age 13 and up (if they provide assent and their parent or guardian gives permission)*
Parents/caregivers of patients of all ages who speak English, Arabic, Armenian, Bengali, Chinese (Mandarin and Cantonese), Karen, Korean, Nepali, Quiche, Spanish, Somali, and Vietnamese (and/or other languages if resources allow)
Nurses working on these units
Residents working on these units
Medical and nursing students working on these units
Hospital leaders working at these hospitals
*Note for Consenting: Patients (13-18yo) who are in state custody and assent for themselves to complete surveys but lack legal guardian/caregiver present to offer consent are not being approached to complete surveys. These patients may still be enrolled in the study but not consented to complete patient-facing forms.
Exclusion Criteria: None

Where it is running

University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
Children's Hospital Los Angeles — Los Angeles, California, United States (enrolling)
UCSF Benioff Children's Hospital of Oakland — Oakland, California, United States (enrolling)
University of Nebraska Medical Center — Omaha, Nebraska, United States (enrolling)
Children's Hospital at Montefiore — The Bronx, New York, United States (enrolling)
The Research Institute of Nationwide Children's Hospital — Columbus, Ohio, United States (enrolling)
UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States (enrolling)
Northwest Texas Healthcare System — Amarillo, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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