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

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

Conditions
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Communication

Intervention / Treatment
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* Behavioral: PFC I-PASS Intervention
* Behavioral: PFC I-PASS+ Intervention


Participation Criteria
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Eligibility Criteria
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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, Chinese (Mandarin and Cantonese), Karen, 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 Exclusion Criteria: Parents/caregivers who do not speak a study language (decided based on the 10 most commonly spoken languages across study sites; study languages include: English, Arabic, Armenian, Chinese (Mandarin and Cantonese), Karen, Nepali, Quiche, Spanish, Somali, and Vietnamese and/or other languages if resources allow)

Ages Eligible for Study
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Minimum Age: 0 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br>Unstructured communication during rounds and unstandardized interpretation at provider discretion. | |
| Experimental: PFC I-PASS Intervention<br>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<br>* 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.<br>|
| Experimental: PFC I-PASS+ Intervention<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient/Family Experience with Care Questionnaire | 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. | 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) | 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. | 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) | Self-reported by patients/families throughout hospitalization. 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. | 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 | 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. | 24 months (including usual care and intervention implementation data collection which will happen sequentially) per site (8 sites total) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Language Barriers, Family Centered Rounds, Patient Safety, Errors, Limited English Proficiency, Health Disparities, Adverse Events, Patient Experience, Family Engagement, Interprofessional Communication