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

NCT05591066 | Recruiting DMC

• 1 other identifier: IRB-P00042876
• Study Type: interventional
• Target: 14,400
• Locations: 1 country
• Sites: 8

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Adverse Event Rates

  Chart review, self-reported by staff and patients/families, and hospital incident reports

  24 months (including usual care and intervention implementation data collection which will happen sequentially) per site (8 sites total)

Secondary Outcomes (4)

• Patient/Family Experience with Care Questionnaire

  24 months (including usual care and intervention implementation data collection which will happen sequentially) per site (8 sites total)

• Patient/Family Experience of Discrimination (Discrimination In Medical Settings Scale)

  24 months (including usual care and intervention implementation data collection which will happen sequentially) per site (8 sites total)

• Safety Climate (The Children's Hospital Safety Climate Questionnaire)

  24 months (including usual care and intervention implementation data collection which will happen sequentially)per site (8 sites total)

• Observations of Quality and Frequency of Communications

  24 months (including usual care and intervention implementation data collection which will happen sequentially) per site (8 sites total)

Study Arms (3)

Usual care

NO INTERVENTION

Unstructured communication during rounds and unstandardized interpretation at provider discretion.

PFC I-PASS Intervention

EXPERIMENTAL

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.

Behavioral: PFC I-PASS Intervention

PFC I-PASS+ Intervention

EXPERIMENTAL

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.

Behavioral: PFC I-PASS+ Intervention

Interventions

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.

PFC I-PASS+ Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Patient-Centered Outcomes Research Institute: collaborator
• Pediatric Research in Inpatient Settings: collaborator

Study Sites (8)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

UCSF Benioff Children's Hospital of Oakland

Oakland, California, 94609, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

Children's Hospital at Montefiore

The Bronx, New York, 10467, United States

RECRUITING

The Research Institute of Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

RECRUITING

Northwest Texas Healthcare System

Amarillo, Texas, 79106, United States

RECRUITING

Related Publications (7)

• Starmer AJ, Spector ND, Srivastava R, West DC, Rosenbluth G, Allen AD, Noble EL, Tse LL, Dalal AK, Keohane CA, Lipsitz SR, Rothschild JM, Wien MF, Yoon CS, Zigmont KR, Wilson KM, O'Toole JK, Solan LG, Aylor M, Bismilla Z, Coffey M, Mahant S, Blankenburg RL, Destino LA, Everhart JL, Patel SJ, Bale JF Jr, Spackman JB, Stevenson AT, Calaman S, Cole FS, Balmer DF, Hepps JH, Lopreiato JO, Yu CE, Sectish TC, Landrigan CP; I-PASS Study Group. Changes in medical errors after implementation of a handoff program. N Engl J Med. 2014 Nov 6;371(19):1803-12. doi: 10.1056/NEJMsa1405556.

  PMID: 25372088 BACKGROUND

• Khan A, Coffey M, Litterer KP, Baird JD, Furtak SL, Garcia BM, Ashland MA, Calaman S, Kuzma NC, O'Toole JK, Patel A, Rosenbluth G, Destino LA, Everhart JL, Good BP, Hepps JH, Dalal AK, Lipsitz SR, Yoon CS, Zigmont KR, Srivastava R, Starmer AJ, Sectish TC, Spector ND, West DC, Landrigan CP; the Patient and Family Centered I-PASS Study Group; Allair BK, Alminde C, Alvarado-Little W, Atsatt M, Aylor ME, Bale JF Jr, Balmer D, Barton KT, Beck C, Bismilla Z, Blankenburg RL, Chandler D, Choudhary A, Christensen E, Coghlan-McDonald S, Cole FS, Corless E, Cray S, Da Silva R, Dahale D, Dreyer B, Growdon AS, Gubler L, Guiot A, Harris R, Haskell H, Kocolas I, Kruvand E, Lane MM, Langrish K, Ledford CJW, Lewis K, Lopreiato JO, Maloney CG, Mangan A, Markle P, Mendoza F, Micalizzi DA, Mittal V, Obermeyer M, O'Donnell KA, Ottolini M, Patel SJ, Pickler R, Rogers JE, Sanders LM, Sauder K, Shah SS, Sharma M, Simpkin A, Subramony A, Thompson ED Jr, Trueman L, Trujillo T, Turmelle MP, Warnick C, Welch C, White AJ, Wien MF, Winn AS, Wintch S, Wolf M, Yin HS, Yu CE. Families as Partners in Hospital Error and Adverse Event Surveillance. JAMA Pediatr. 2017 Apr 1;171(4):372-381. doi: 10.1001/jamapediatrics.2016.4812.

  PMID: 28241211 BACKGROUND

• Khan A, Spector ND, Baird JD, Ashland M, Starmer AJ, Rosenbluth G, Garcia BM, Litterer KP, Rogers JE, Dalal AK, Lipsitz S, Yoon CS, Zigmont KR, Guiot A, O'Toole JK, Patel A, Bismilla Z, Coffey M, Langrish K, Blankenburg RL, Destino LA, Everhart JL, Good BP, Kocolas I, Srivastava R, Calaman S, Cray S, Kuzma N, Lewis K, Thompson ED, Hepps JH, Lopreiato JO, Yu CE, Haskell H, Kruvand E, Micalizzi DA, Alvarado-Little W, Dreyer BP, Yin HS, Subramony A, Patel SJ, Sectish TC, West DC, Landrigan CP. Patient safety after implementation of a coproduced family centered communication programme: multicenter before and after intervention study. BMJ. 2018 Dec 5;363:k4764. doi: 10.1136/bmj.k4764.

  PMID: 30518517 BACKGROUND

• Khan A, Yin HS, Brach C, Graham DA, Ramotar MW, Williams DN, Spector N, Landrigan CP, Dreyer BP; Patient and Family Centered I-PASS Health Literacy Subcommittee. Association Between Parent Comfort With English and Adverse Events Among Hospitalized Children. JAMA Pediatr. 2020 Dec 1;174(12):e203215. doi: 10.1001/jamapediatrics.2020.3215. Epub 2020 Dec 7.

  PMID: 33074313 BACKGROUND

• Parente VM, Khan A, Robles JM. Belonging on Rounds: Translating Research Into Inclusive Practices for Families With Limited English Proficiency to Promote Safety, Equity, and Quality. Hosp Pediatr. 2022 May 1;12(5):e171-e173. doi: 10.1542/hpeds.2022-006581. No abstract available.

  PMID: 35411380 BACKGROUND

• Khan A, Quinones-Perez B, Castellanos A, Garcia S, MacInnes E. Promoting true meaningful access and equity for patients and clinicians through the use of certified interpreters in hospitals. J Hosp Med. 2022 Sep;17(9):772-773. doi: 10.1002/jhm.12943. Epub 2022 Aug 17. No abstract available.

  PMID: 35977037 BACKGROUND

• Khan A, Parente V, Baird JD, Patel SJ, Cray S, Graham DA, Halley M, Johnson T, Knoebel E, Lewis KD, Liss I, Romano EM, Trivedi S, Spector ND, Landrigan CP; Patient and Family Centered I-PASS SCORE Scientific Oversight Committee; Bass EJ, Calaman S, Fegley AE, Knighton AJ, O'Toole JK, Sectish TC, Srivastava R, Starmer AJ, West DC. Association of Patient and Family Reports of Hospital Safety Climate With Language Proficiency in the US. JAMA Pediatr. 2022 Aug 1;176(8):776-786. doi: 10.1001/jamapediatrics.2022.1831.

  PMID: 35696195 BACKGROUND

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Alisa Khan, MD, MPH

  Boston Children's Hospital/Harvard Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alisa Khan, MD, MPH

CONTACT

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

Elizabeth Micolisin, BS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Hospitalist/Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 24, 2022
• Study Start: March 26, 2024
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)