The Patient and Family Centered I-PASS LISTEN Study: Language, Inclusion, Safety, and Teamwork for Equity Now
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Communication
- Sponsor
- Boston Children's Hospital
- Enrollment
- 14400
- Locations
- 8
- Primary Endpoint
- Adverse Event Rates
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
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
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.
Investigators
Alisa Khan
Pediatric Hospitalist/Assistant Professor of Pediatrics
Boston Children's Hospital
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
- Not provided
Outcomes
Primary Outcomes
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
- 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))