NCT05591066 The Patient and Family Centered I-PASS LISTEN Study: Language, Inclusion, Safety, and Teamwork for Equity Now
| NCT ID | NCT05591066 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston Children's Hospital |
| Condition | Communication |
| Study Type | INTERVENTIONAL |
| Enrollment | 14,400 participants |
| Start Date | 2024-03-26 |
| Primary Completion | 2028-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 14,400 participants in total. It began in 2024-03-26 with a primary completion date of 2028-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Alisa Khan, MD, MPH
PRINCIPAL INVESTIGATOR
Boston Children's Hospital/Harvard Medical School
Frequently Asked Questions
Who can join the NCT05591066 clinical trial?
This trial is open to participants of all sexes, studying Communication. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05591066 currently recruiting?
Yes, NCT05591066 is actively recruiting participants. Contact the research team at alisa.khan@childrens.harvard.edu for enrollment information.
Where is the NCT05591066 trial being conducted?
This trial is being conducted at Birmingham, United States, Los Angeles, United States, Oakland, United States, Omaha, United States and 4 additional locations.
Who is sponsoring the NCT05591066 clinical trial?
NCT05591066 is sponsored by Boston Children's Hospital. The principal investigator is Alisa Khan, MD, MPH at Boston Children's Hospital/Harvard Medical School. The trial plans to enroll 14,400 participants.