RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-03-26
Study Completion:2028-11-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05591066

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:0 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * All patients admitted to the pediatric inpatient study units of participating hospitals
  2. * Patients themselves who are age 13 and up (if they provide assent and their parent or guardian gives permission)\*
  3. * 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)
  4. * Nurses working on these units
  5. * Residents working on these units
  6. * Medical and nursing students working on these units
  7. * Hospital leaders working at these hospitals
  8. * \*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.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Alisa Khan, MD, MPH
CONTACT
617-355-2565
alisa.khan@childrens.harvard.edu
Angie Fan, BA
CONTACT
617-355-6010
angie.fan@childrens.harvard.edu

Principal Investigator

Alisa Khan, MD, MPH
PRINCIPAL_INVESTIGATOR
Boston Children's Hospital/Harvard Medical School

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35233
United States
Children's Hospital Los Angeles
Los Angeles, California, 90027
United States
UCSF Benioff Children's Hospital of Oakland
Oakland, California, 94609
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198
United States
Children's Hospital at Montefiore
Bronx, New York, 10467
United States
The Research Institute of Nationwide Children's Hospital
Columbus, Ohio, 43205
United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
United States
Northwest Texas Healthcare System
Amarillo, Texas, 79106
United States

Collaborators and Investigators

Sponsor: Boston Children's Hospital

  • Alisa Khan, MD, MPH, PRINCIPAL_INVESTIGATOR, Boston Children's Hospital/Harvard Medical School

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-26
Study Completion Date2028-11-01

Study Record Updates

Study Start Date2024-03-26
Study Completion Date2028-11-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Communication