A Multicenter Randomized Controlled Trial of a Patient Safety Reporting Intervention for Families to Improve Medical Error Detection and Reduce Inequities

针对家庭的患者安全报告干预措施的多中心随机对照试验，以改善医疗错误检测并减少不平等

• 批准号: 10444085
• 负责人: Alisa Khan
• 金额: $ 39.84万
• 依托单位: BOSTON CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-01 至 2027-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10444085
• 关键词: Multicenter; Randomized; Controlled; Trial; Patient

PROJECT SUMMARY/ABSTRACT Hospitals ineffectively examine the safety of their processes by relying on voluntary incident reporting (VIR) by clinical staff who are overworked and afraid to report. VIR captures only 1-10% of events, excludes patients and families, and underdetects events in vulnerable groups like patients with language barriers. Patients and families are vigilant partners in care who are adept at identifying errors and AEs. Failing to actively include pa- tients and families in safety reporting and instead relying on flawed VIR presents an important missed oppor- tunity to improve safety. To improve hospital safety, there is a critical need to coproduce (create in partnership with families) effective systems to identify uncaptured errors. Without this information, hospitals are impeded in their ability to improve patient safety. In partnership with diverse families, nurses, physicians, and hospital lead- ers, we created a multicomponent communication intervention to engage families of hospitalized children in safety reporting. Known as FACES (“Family Activation and Communication about Errors and Safety”), the in- tervention includes 3 elements: (1) a Spanish and English mobile (email, text, and QR-code) FACES reporting tool prompting families to share concerns and suggestions about safety, (2) family/staff education, and (3) a process for sharing family reports with the unit and hospital so systemic issues can be addressed. After pilot- ing FACES in one inpatient unit, we saw marked improvements in family safety reporting and reductions in dis- parities in reporting by parent education and language. We now propose to conduct an RCT of FACES in 4 geographically, ethnically, and linguistically diverse hospitals. Our specific aims are to: (1) evaluate the effec- tiveness of FACES in improving error detection and other safety outcomes, (2) assess the impact of FACES on disparities in reporting, and (3) understand contextual factors contributing to successful implementation of FACES. If effective, FACES will contribute by: (1) increasing patient/family engagement in reporting, espe- cially from vulnerable groups, (2) identifying otherwise unrecognized events, and (3) enabling hospitals to bet- ter understand safety problems in a 360-degree manner and design more effective, patient-centered solutions. This is significant because hospitals need to identify medical errors reliably in order to improve patient safety. The proposed research is innovative because it extends family safety reporting from the research to the oper- ational real-world context; compares patient/family safety reporting to flawed existing VIR; and is informed by principles of coproduction, communication science, health literacy, and organizational behavior. It also involves a novel strategy to share learnings, ensuring concerns are acted upon to improve patient safety in a manner that matters to patients and families. Finally, it focuses on the intersection between safety and equity. This study will achieve our long-term objective to coproduce with families evidence-based strategies to make hos- pital care safer, higher quality, and more equitable, in line with AHRQ's mission. It intersects multiple priorities highlighted by AHRQ, including children (a priority population), safety, and equity (SEN NOT-HS-21-014).

项目总结/摘要 医院依靠自愿事件报告（VIR），无法有效地检查其流程的安全性， 临床工作人员过度劳累，不敢报告。VIR仅捕获1-10%的事件，不包括患者 和家庭，并低估了有语言障碍的患者等弱势群体的事件。患者和 家庭是护理中的警惕伙伴，善于识别错误和AE。如果没有积极参与， 安全报告中的受害者和家庭，而不是依赖有缺陷的VIR，这是一个重要的错失机会- 协调以提高安全性。为了改善医院安全，迫切需要共同生产（合作创造 与家庭）有效的系统来识别未捕获的错误。如果没有这些信息，医院将无法 提高患者安全的能力。与不同的家庭，护士，医生和医院领导合作- 我们创建了一个多成分的沟通干预，让住院儿童的家庭参与， 安全报告。被称为FACES（“家庭激活和关于错误和安全的通信”）， 干预包括3个要素：（1）西班牙语和英语移动的（电子邮件，文本和QR码）FACES报告 一个工具，促使家庭分享对安全的关注和建议，（2）家庭/工作人员教育，以及（3） 与单位和医院共享家庭报告的流程，以便解决系统性问题。在飞行员之后- 在一个住院单位的面部，我们看到家庭安全报告的显着改善和减少， 按父母教育程度和语言分列的报告人数均等。我们现在建议在4个国家进行面部随机对照试验。 地理上种族上和语言上都不同的医院我们的具体目标是：（1）评估效果， FACES在改善错误检测和其他安全结果方面的有效性，（2）评估FACES对 报告中的差异，以及（3）了解有助于成功实施 脸上如果有效，FACES将通过以下方式做出贡献：（1）增加患者/家属对报告的参与，特别是- （2）识别其他未识别的事件，（3）使医院能够更好地- 以360度的方式了解安全问题，并设计更有效的，以患者为中心的解决方案。 这一点很重要，因为医院需要可靠地识别医疗差错，以提高患者安全。 拟议的研究是创新的，因为它扩展了家庭安全报告从研究到操作， 国家真实世界背景;将患者/家庭安全报告与有缺陷的现有VIR进行比较;并通过以下方式获得信息 合作生产的原则，传播科学，健康素养和组织行为。它还涉及 一种分享学习的新策略，确保对问题采取行动，以提高患者安全性， 对病人和家属来说至关重要最后，它侧重于安全与公平之间的交叉点。这 研究将实现我们的长期目标，即与家庭共同制定基于证据的策略，以使住房- 根据AHRQ的使命，更安全、更高质量和更公平的医院护理。它涉及多个优先事项 AHRQ强调，包括儿童（优先人群）、安全和公平（SEN NOT-HS-21-014）。