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NCT Number: NCT05591066

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

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.

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Key information

Conditions

Communication Behavior

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

Hospitalized patients who use languages other than English (LOE, Box 1) for care are at high risk for adverse events (AEs) due to communication failures. These failures include underutilizing safety-promoting strategies, such as certified interpreters, high-reliability structured communication, and family engagement. Patients using LOE also face individual bias from providers (eg, assuming lower intelligence based on accent) and systemic bias from systems not designed to meet their needs (eg, hospitals failing to invest in translation services), which lead to safety risks and poorer health. Patients using LOE also face intersectional bias based on race and ethnicity and other characteristics.

With PCORI's support, the investigators developed a structured communication intervention-Patient and Family Centered I-PASS (PFC I-PASS)-to improve family engagement on rounds that led to a 38% reduction in preventable AEs and improved hospital experience. In the subset of patients/families with language barriers, AEs and hospital experience improved further. However, sites struggled with how to implement PFC I-PASS in patients using LOE for care. Disparities in family engagement in patients using LOE for care persisted and interpreter use varied. The investigators have bolstered PFC I-PASS with evidence-based strategies, including standardized use of certified in-person and video interpreters during and after rounds, cultural humility training, and provider communication skills training (PFC I-PASS+).

The overall goal of this project is to compare the effectiveness of PFC I-PASS+ and PFC I-PASS vs usual care (unstructured communication and unstandardized interpretation at provider discretion) in a population of hospitalized children using LOE (PCORI populations of interest). To pursue this goal, the investigators will conduct a multicenter Hybrid Type I effectiveness trial. The investigators will randomize 4 sites to PFC I-PASS+ and 4 site to PFC I-PASS, using a Stepped Wedge Cluster Randomized Trial (SW-CRT) design to compare the effectiveness of PFC I-PASS and I-PASS+ vs usual care. The investigators will compare safety, experience, discrimination, and communication using gold standard systematic safety surveillance and patient/ family-reported measures. Our primary aim is to test the hypothesis that among patients using LOE for care, both PFC I-PASS+ and PFC I-PASS, vs usual care, will improve: AE rates, patient/family experience of provider communication and experience of discrimination, and communication openness, and frequency of patient-provider communications using interpreters.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Adverse Event Rates

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

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

Secondary outcomes

  1. Patient/Family Experience with Care Questionnaire

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

    Self-reported by patients/families prior to discharge, based on a previously developed experience survey and modified Child HCAHPS items. Most items are scored on a 5-point Likert scale with higher numbers being better. Top-box (5 or 5 out of 5 scores) will be analyzed.

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

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

    Self-reported by patients/families prior to discharge through the Discrimination in Medical Settings (DMS) Scale, which is a modified version of the Everyday Discrimination Scale (EDS) adapted to medical settings. The EDS is one of the most utilized self-reported measures of discrimination and is validated across multiple populations. The 7-item DMS Scale has excellent convergent validity and discriminant validity, internal consistency, test-retest reliability, and is used in a variety of clinical conditions. Items include whether patients are treated with less courtesy, less respect, receive poorer services; whether doctor or nurse acts as if patient is not smart, better than patient, or does not listen to patient. Responses were assessed with a 5-point Likert scale (1-never, 2-rarely, 3-sometimes, 4-most of the time, 5-always). The investigators will evaluate top-box (topmost, ie, "never") scores for this measure.

  3. Safety Climate (The Children's Hospital Safety Climate Questionnaire)

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

    Self-reported by patients/families prior to discharge. The Children's Hospital Safety Climate Questionnaire includes 14 Likert-scale (agreement on a 5 point scale from "strongly agree" to "strongly disagree") questions related to parent perceptions of safety climate during hospitalization. It was adapted from the AHRQ Hospital Survey on Patient Safety Culture for staff and validated using confirmatory factor analysis. Domains include perceptions of safety, staff communication openness, parent communication openness, and handoffs and transitions. Items of interest relate to the communication openness domain. Top-box (top-most/best) scores will be analyzed.

  4. Observations of Quality and Frequency of Communications

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

    Direct observations (by study staff) will measure the frequency of (1) overall communications between patients/families and providers, (2) language-concordant communications among patients and providers (times a provider communicates with a patient/family in a language the patient understands), and (3) interpreter-facilitated communications among patients with LEP. The type of communications and their quality will also be observed. The study team has used direct observations to measure frequency, type, and quality of communication reliably in multiple prior studies and will modify these prior measures to assess communication.

Study contacts

Contact information is provided by the study sponsor or research team.

Alisa Khan, MD, MPH

CONTACT

[email protected]

617-355-2565

Elizabeth Micolisin, BS

CONTACT

[email protected]

617-355-6010

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • Patient-Centered Outcomes Research Institute
  • Pediatric Research in Inpatient Settings

Registry information

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Oct 24, 2022
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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