跳至主要内容
临床试验/NCT05591066
NCT05591066招募中不适用

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

Boston Children's Hospital13 个研究点 分布在 1 个国家目标入组 14,400 人开始时间: 2024年3月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
14,400
试验地点
13
主要终点
Adverse Event Rates

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 未提供

研究组 & 干预措施

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.

干预措施: PFC I-PASS Intervention (Behavioral)

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.

干预措施: PFC I-PASS+ Intervention (Behavioral)

结局指标

主要结局

Adverse Event Rates

时间窗: 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

次要结局

  • 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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alisa Khan

Pediatric Hospitalist/Assistant Professor of Pediatrics

Boston Children's Hospital

研究点 (13)

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