A multicenter randomized trial to improve family clinical note access and outcomes for hospitalized children: The Bedside Notes study protocol.

introductionThe 2021 Cures Act mandates caregiver access to their child's medical notes with few exceptions, yet fewer than 10% access notes during hospitalization. Caregiver review of real-time notes facilitates identification of safety concerns and may enhance patient safety in pediatric hospitals. This trial will evaluate the Bedside Notes intervention-a multifaceted approach to enhance real-time access to inpatient notes-and its effects on caregiver activation, hospital experience, reporting of safety concerns found in notes, and anxiety.

methodsThis 5-year, multisite randomized controlled trial will enroll 600 English and Spanish-speaking caregivers of hospitalized children ≤11 years old and 30 hospital staff across three hospitals. Caregivers will be randomized to usual care or the Bedside Notes intervention, which includes real-time inpatient note access via a bedside tablet, a caregiver orientation video, and a glossary of terms commonly found in notes. Our primary outcome is note access; secondary outcomes are caregiver activation, hospital experience, safety concerns, and anxiety, measured through electronic health record audits, surveys, and interviews. DISCUSSION: We hypothesize that Bedside Notes will significantly improve caregiver note access, activation, hospital experience, and safety concern reporting without increasing caregiver anxiety. This study will also identify barriers and facilitators to accessing inpatient notes and inform scalable implementation strategies for caregiver engagement in hospital safety. Findings will advance efforts to reduce errors and improve family-centered care in pediatric hospital settings.