The Patient and Family Centered I-PASS LISTEN Study: Language, Inclusion, Safety, and Teamwork for Equity Now
- Conditions
- Communication
- Interventions
- Behavioral: PFC I-PASS InterventionBehavioral: PFC I-PASS+ Intervention
- Registration Number
- NCT05591066
- Lead Sponsor
- Boston Children's Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 14400
- 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.
None
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description PFC I-PASS Intervention 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. PFC I-PASS+ Intervention 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 Measures
Name Time Method Adverse Event Rates 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 Outcome Measures
Name Time Method 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) 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). We will evaluate top-box (topmost, ie, "never") scores for this measure.
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) 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.
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) 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.
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) 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.
Trial Locations
- Locations (8)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
UPMC Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
UCSF Benioff Children's Hospital of Oakland
🇺🇸Oakland, California, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Children's Hospital at Montefiore
🇺🇸Bronx, New York, United States
The Research Institute of Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Northwest Texas Healthcare System
🇺🇸Amarillo, Texas, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States