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

Last updated: June 18, 2025
Sponsor: Boston Children's Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

PFC I-PASS+ Intervention

PFC I-PASS Intervention

Clinical Study ID

NCT05591066
IRB-P00042876
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All patients admitted to the pediatric inpatient study units of participatinghospitals

  • Patients themselves who are age 13 and up (if they provide assent and their parentor 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 forthemselves to complete surveys but lack legal guardian/caregiver present to offerconsent are not being approached to complete surveys. These patients may still beenrolled in the study but not consented to complete patient-facing forms.

Exclusion

Exclusion Criteria: None

Study Design

Total Participants: 14400
Treatment Group(s): 2
Primary Treatment: PFC I-PASS+ Intervention
Phase:
Study Start date:
March 26, 2024
Estimated Completion Date:
November 01, 2028

Study Description

Hospitalized patients who use languages other than English (LOE, Box 1) for care are at high risk for adverse events (AEs) due to communication failures. These failures include underutilizing safety-promoting strategies, such as certified interpreters, high-reliability structured communication, and family engagement. Patients using LOE also face individual bias from providers (eg, assuming lower intelligence based on accent) and systemic bias from systems not designed to meet their needs (eg, hospitals failing to invest in translation services), which lead to safety risks and poorer health. Patients using LOE also face intersectional bias based on race and ethnicity and other characteristics.

With PCORI's support, the investigators developed a structured communication intervention-Patient and Family Centered I-PASS (PFC I-PASS)-to improve family engagement on rounds that led to a 38% reduction in preventable AEs and improved hospital experience. In the subset of patients/families with language barriers, AEs and hospital experience improved further. However, sites struggled with how to implement PFC I-PASS in patients using LOE for care. Disparities in family engagement in patients using LOE for care persisted and interpreter use varied. The investigators have bolstered PFC I-PASS with evidence-based strategies, including standardized use of certified in-person and video interpreters during and after rounds, cultural humility training, and provider communication skills training (PFC I-PASS+).

The overall goal of this project is to compare the effectiveness of PFC I-PASS+ and PFC I-PASS vs usual care (unstructured communication and unstandardized interpretation at provider discretion) in a population of hospitalized children using LOE (PCORI populations of interest). To pursue this goal, the investigators will conduct a multicenter Hybrid Type I effectiveness trial. The investigators will randomize 4 sites to PFC I-PASS+ and 4 site to PFC I-PASS, using a Stepped Wedge Cluster Randomized Trial (SW-CRT) design to compare the effectiveness of PFC I-PASS and I-PASS+ vs usual care. The investigators will compare safety, experience, discrimination, and communication using gold standard systematic safety surveillance and patient/ family-reported measures. Our primary aim is to test the hypothesis that among patients using LOE for care, both PFC I-PASS+ and PFC I-PASS, vs usual care, will improve: AE rates, patient/family experience of provider communication and experience of discrimination, and communication openness, and frequency of patient-provider communications using interpreters.

Connect with a study center

  • University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • Children's Hospital Los Angeles

    Los Angeles, California 90027
    United States

    Active - Recruiting

  • UCSF Benioff Children's Hospital of Oakland

    Oakland, California 94609
    United States

    Active - Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198
    United States

    Active - Recruiting

  • Children's Hospital at Montefiore

    Bronx, New York 10467
    United States

    Active - Recruiting

  • The Research Institute of Nationwide Children's Hospital

    Columbus, Ohio 43205
    United States

    Active - Recruiting

  • UPMC Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania 15224
    United States

    Active - Recruiting

  • Northwest Texas Healthcare System

    Amarillo, Texas 79106
    United States

    Active - Recruiting

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