Recruiting

Observational Study

Sponsor:

Boston Children's Hospital

Code:

NCT05591066

Conditions

Communication

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

PFC I-PASS Intervention

PFC I-PASS+ Intervention

Study Details

Brief 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

Communication

Study ID

NCT05591066

Start date

Mar 26, 2024

Status verified date

Jun, 2025

Completion date

Nov 1, 2028

Anticipated

Primary completion date

Nov 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Study Design

Enrollment

14400 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

no intervention: Usual care

Unstructured communication during rounds and unstandardized interpretation at provider discretion.

experimental: PFC I-PASS Intervention

Patient and Family-Centered I-PASS is 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. The intervention included a health literacy-informed, structured communication framework for family-centered rounds; written rounds summaries for families; a training and learning program; and strategies to support teamwork and implementation.

experimental: PFC I-PASS+ Intervention

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.

Interventions

PFC I-PASS Intervention

Patient and Family-Centered I-PASS is 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. The intervention included a health literacy-informed, structured communication framework for family-centered rounds; written rounds summaries for families; a training and learning program; and strategies to support teamwork and implementation.

PFC I-PASS+ Intervention

PFC I-PASS+ builds on PFC I-PASS to make it better and focus on the special needs of patients who speak languages other than English. PFC I-PASS+ includes all parts of PFC I-PASS plus having interpreters during and after rounds, cultural humility training, and provider communication skills training.

Primary outcome measure

  • Adverse Event Rates [ Time Frame: 24 months (including usual care and intervention implementation data collection which will happen sequentially) per site (8 sites total) ]

Central Contacts and Locations

Central contacts

Alisa Khan, MD, MPH

617-355-2565alisa.khan@childrens.harvard.edu

Elizabeth Micolisin, BS

617-355-6010elizabeth.micolisin@childrens.harvard.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Erin Shaughnessy, MD, MSHCM

205-638-9922eshaughnessy@uabmc.edu

Lauren Nassetta, MD

lkbrewer@uab.edu

Children's Hospital Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

Angela Choe, MD

323-361-6177anchoe@chla.usc.edu

Susan Wu, MD

323-361-6177suwu@chla.usc.edu

UCSF Benioff Children's Hospital of Oakland

Recruiting

Oakland, California, United States, 94609

Contacts

Dorea Martin, MD

510-428-3885dorea.martin@ucsf.edu

Suzy Chen, MD

510428-3331Suzy.Chen@ucsf.edu

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Aleisha Nabower, MD

402-955-4140aleisha.nabower@unmc.edu

Children's Hospital at Montefiore

Recruiting

The Bronx, New York, United States, 10467

Contacts

Theresa Serra, MD

718-741-2470tserra@montefiore.org

Courtney McNamara, MD

718-741-2470comcnama@montefiore.org

The Research Institute of Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Cara Harasaki, MD, MPH

614-722-0417cara.harasaki@nationwidechildrens.org

Shauna Schord, MD

614-722-4998Shauna.Schord@nationwidechildrens.org

UPMC Children's Hospital of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Andrew Buchert, MD

412-692-7288andrew.buchert@chp.edu

Northwest Texas Healthcare System

Recruiting

Amarillo, Texas, United States, 79106

Contacts

Raphael J Mattamal, MD, FAAP

504-491-0495Raphael.Mattamal@ttuhsc.edu

Sayyidda Mohammed, MD

sayyidda.mohammed@ttuhsc.edu

More Information

Sponsor

Boston Children's Hospital

Last update posted

Jun 24, 2025

Last verified

Jun, 2025

Keywords

  • Family Centered Rounds
  • Patient Safety
  • Errors
  • Limited English Proficiency
  • Health Disparities
  • Adverse Events
  • Patient Experience
  • Family Engagement
  • Interprofessional Communication
  • Language Barriers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2025-06-24.