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

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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).