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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Boston Children's Hospital
Study ID
NCT05591066
Status
Recruiting
Apply to this trial

Conditions

  • Communication

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • PFC I-PASS Intervention — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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 Dates

Start date
Mar 26, 2024
Status verified
Jun 2025
Primary completion
Nov 1, 2028
Completion
Nov 1, 2028

Study Design

Enrollment
14,400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH

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.

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

Locations (8)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233
Erin Shaughnessy, MD, MSHCM
[email protected]
205-638-9922
Lauren Nassetta, MD
[email protected]
Children's Hospital Los AngelesLos AngelesCalifornia90027
Angela Choe, MD
[email protected]
323-361-6177
Susan Wu, MD
[email protected]
323-361-6177
UCSF Benioff Children's Hospital of OaklandOaklandCalifornia94609
Dorea Martin, MD
[email protected]
510-428-3885
Suzy Chen, MD
[email protected]
510428-3331
University of Nebraska Medical CenterOmahaNebraska68198
Aleisha Nabower, MD
[email protected]
402-955-4140
Christopher Edwards, MD
Children's Hospital at MontefioreThe BronxNew York10467
Theresa Serra, MD
[email protected]
718-741-2470
Courtney McNamara, MD
[email protected]
718-741-2470
Patricia Hametz, MD (SUB_INVESTIGATOR)
The Research Institute of Nationwide Children's HospitalColumbusOhio43205
Cara Harasaki, MD, MPH
[email protected]
614-722-0417
Shauna Schord, MD
[email protected]
614-722-4998
UPMC Children's Hospital of PittsburghPittsburghPennsylvania15224
Andrew Buchert, MD
[email protected]
412-692-7288
Northwest Texas Healthcare SystemAmarilloTexas79106
Raphael J Mattamal, MD, FAAP
[email protected]
504-491-0495
Sayyidda Mohammed, MD
[email protected]

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALChildren's Hospital Los Angeles· Los Angeles, CAUCSF Benioff Children's Hospital of Oakland· Oakland, CAUniversity of Nebraska Medical Center· Omaha, NEChildren's Hospital at Montefiore· The Bronx, NYThe Research Institute of Nationwide Children's Hospital· Columbus, OH

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