Family Input for Quality and Safety Dissemination and Implementation

Adverse patient safety event rates remain stubbornly high in hospitals. For children, adverse events are 1.5-2 times more common than in adult inpatients (40.0 vs. 25.1 harms/100 admissions). Family members and patients are often close observers of care, focusing on only one patient and one set of diagnoses. Text messaging and mobile phone applications technologies offer the opportunity to gather patients’ and families’ safety reports in real-time, addressing limitations of prior work. The PI and team co-designed a mobile phone- based approach, the Family Input for Quality and Safety (FIQS) with families and clinicians. They tested it across 3 local hospitals and 9 units, successfully engaging family members, patients, staff, and safety and quality leadership, and leading to safety improvement projects. The objectives of this proposal are to address key outstanding dissemination and implementation questions, focusing on minimizing sign-up burden, supporting ongoing participant engagement, and enhancing related safety efforts, informed by the CFIR framework. Aim 1: In a cluster-randomized study (n=5645, 15 units), assess the effect of two sign-up strategies (text only, text with in-person orientation) on reporting rates, and interactions by race, ethnicity, & language. Hypothesis: Rates of enrollment and safety-oriented reporting will differ between strategies. Aim 2: In a 1:1 randomized trial, test the effect of two engagement strategies on patient and family safety reporting rates, and interactions by race, ethnicity, & language (n=3386). Group 1 participants: Reports will be shared with units without identifiers (unless requested). Group 2 participants: All reports are shared with units with identifiers. Hypothesis: Reporting rates will be higher for those whose reports are not identified, who access the website, and for whom there is service recovery; results may vary by race, ethnicity, or language. Aim 3: Using mixed methods, evaluate barriers and facilitators to the successful integration of FIQS data into safety efforts. Over an 18-month implementation period, in 21 units, assess inner drivers of uptake & outcomes. Quantitative outcomes: # of units integrating FIQS report reviews into existing safety workflows; numbers of FIQS reports reviewed, # of system-level interventions undertaken and completed. Qualitative data: characterization of interventions made in response to FIQS reports; barriers and facilitators of successful integration of FIQS reports into safety. The proposed research is innovative in its paradigm-shifting conceptual model of 1) its use of mobile phone technology for real time safety reporting, with highly feasible patient-level randomization, and 2) text-message based opt-out approach, to engage patients and caregivers to share safety observations, moving prior evidence into real-world implementation. The contribution of the research will be to answer key dissemination and implementation questions about using patient-facing digital technology to improve patient safety, in partnership with unit leaders and families. These contributions will be significant because they are key to implement and evaluate a potential new approach to improving inpatient safety. Project Number: 1R01HD119441-01 | Fiscal Year: 2025 | NIH Institute/Center: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Principal Investigator: Naomi Bardach | Institution: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, SAN FRANCISCO, CA | Award Amount: $735,531 | Activity Code: R01 | Study Section: Science of Implementation in Health and Healthcare Study Section[SIHH] View on NIH RePORTER: https://reporter.nih.gov/project-details/1R01HD11944101