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).

项目摘要/摘要 医院通过依靠自愿事件报告（VIR）而无效地检查其过程的安全性 过度劳累且害怕报告的临床人员。 Vir仅捕获1-10％的事件，排除患者 和家庭，以及诸如具有语言障碍的患者等弱势群体中的事件。病人和 家庭是警惕的伴侣，他们适应识别错误和AES。未能积极包括Pa- 在安全报告中的特征和家庭，而依靠有缺陷的VIR提出了一个重要的错过的opporpor- 提高安全性。为了提高医院的安全，至关重要的需要（建立合作伙伴） 与家庭）有效的系统来识别未受到的错误。没有这些信息，医院就会受到阻碍 他们提高患者安全的能力。与潜水员家庭，护士，医师和医院负责人合作 - ers，我们创建了一个多组分的沟通干预措施，使住院儿童的家庭参与 安全报告。被称为面孔（“关于错误和安全的家庭激活和沟通”），In- 延长包括3个元素：（1）西班牙语和英语手机（电子邮件，文本和QR代码）面孔报告 工具促使家庭分享有关安全，（2）家庭/员工教育和（3）A的关注和建议 飞行员之后 - 在一个住院单位中的面孔，我们看到家庭安全报告和降低的明显改善 父母教育和语言报告的奇偶群。现在，我们建议在4中进行一张面孔 在地理，种族和语言上多样化的医院。我们的具体目的是：（1）评估EFCI- 面孔在改善错误检测和其他安全结果方面的能力，（2）评估面孔对 报告的差异以及（3）了解有助于成功实施的上下文因素 面孔。如果有效，面孔将通过以下方式做出贡献：（1）增加患者/家庭参与报告，特别是 来自脆弱的群体，（2）确定原本未认可的事件，（3）使医院能够下注 - 以360度的方式了解安全问题，并设计更有效，以患者为中心的解决方案。 这很重要，因为医院需要可靠地确定医疗错误，以提高患者的安全。 拟议的研究具有创新性，因为它将家庭安全报告从研究扩展到运营 现实世界的环境；将患者/家庭安全报告与现有的VIR有缺陷进行比较；并告知 共同制作，传播科学，健康素养和组织行为的原则。它也涉及 分享学习的新型策略，以确保以某种方式提高患者安全的关注 这对患者和家庭很重要。最后，它着重于安全与公平之间的交集。这 研究将实现我们的长期目标，以与家庭循证策略相结合，以使HOS- 与AHRQ的使命一致，Pital Care更安全，质量更高，更公平。它与多个优先级相交 由AHRQ强调，包括儿童（优先人口），安全性和权益（SEN NOT-HS-21-014）。