A Trial to Improve Family Clinical Note Access and Outcomes for Hospitalized Children

Bedside Notes: A Multicenter Trial to Improve Family Clinical Note Access and Outcomes for Hospitalized Children

This study will test if giving parents access to their child's medical notes on a bedside tablet:

• helps them get more involved in their care
• helps identify safety concerns

Parents of hospitalized children will be randomly assigned to either use the Bedside Notes tool or follow usual care.

To see if this approach improves care and safety, researchers will measure:

• note access
• parent-reported safety concerns
• overall experiences

Study Overview

• Status: Recruiting
• Conditions: Medical Errors; Hospitalized Child; Pediatric Patient Safety; Parental Engagement in Care; Inpatient Pediatric Care
• Intervention / Treatment: Other: Access to medical notes

Detailed Description

Hospitalized children face alarming rates of harm due to medical errors, yet parents often lack access to the clinical information necessary to partner effectively in their child's care. Although clinicians are required to share inpatient clinical notes detailing diagnoses and treatment plans, <10% of parents access these notes during hospitalization. To address this critical gap, we developed the Bedside Notes intervention, a multicomponent strategy to improve parent access to clinical notes during their child's hospitalization and engage them in safety efforts. The intervention includes: (1) real-time access to inpatient notes through their child's patient portal on a bedside tablet and (2) a notes orientation video. In a single-center study, this intervention was associated with a >10-fold increase in parent note access and enabled 20% of parents to identify potential safety concerns, with 60% of these concerns confirmed as safety issues.

This multisite randomized controlled trial (RCT) will evaluate the effectiveness of the Bedside Notes intervention in improving parent access to inpatient notes and enhancing safety reporting. Specific aims are to: (1) assess the impact of the intervention on parent note access, (2) evaluate its effect on parent-reported safety concerns and experiences, and (3) identify barriers and facilitators to implementation. Guided by the Systems Engineering Initiative for Patient Safety 2.0 framework, this hybrid type 1 RCT will enroll English- and Spanish-speaking parents of 600 children admitted to pediatric services at three hospitals. Parents will be randomized to either: (1) usual care (access to outpatient portals on personal devices) or (2) the Bedside Notes intervention (proxy access to patient portal on bedside tablets with accompanying orientation video). A subset of parents and healthcare staff will also be interviewed about their experience with the intervention. Data will be collected through surveys, interviews, and electronic health record audits.

This study is the first multisite RCT to evaluate the impact of inpatient note access on parent-reported outcomes. By leveraging bilingual recruitment, two EHR platforms, and input from a national advisory group, the study addresses barriers to equitable access and sustainability. Findings will advance understanding of how health information technology can engage parents as partners in improving inpatient safety for children and inform broader efforts to integrate families into safety initiatives.

• Study Type: Interventional
• Enrollment (Estimated): 630
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michelle Kelly, MD, PhD; Phone Number: (608) 265-5545; Email: michelle.kelly@wisc.edu
• Study Contact Backup: Name: Amanda Gatewood; Email: akgatewood@pediatrics.wisc.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Recruiting
      • Children's Hospital of Los Angeles
      • Sub-Investigator: Anna Egan, MD
  • Washington
    • Seattle, Washington, United States, 98105
      • Not yet recruiting
      • Seattle Children's Hospital
      • Sub-Investigator: Arti Desai, MD
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Recruiting
      • American Family Children's Hospital
      • Principal Investigator: Michelle Kelly, MD, PhD
      • Sub-Investigator: Ryan Coller, MD, MPH
      • Sub-Investigator: Catherine Arnott Smith, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• English and Spanish-speaking parents or guardians of children under 12 years old who were hospitalized on a general pediatric service at one of the 3 centers
• Age 18 and over

Exclusion Criteria:

• Parents of children 12 years of age and older
• Parents unable to give written informed consent
• Parents of children admitted for suspected abuse or neglect
• Anticipated discharge within 24 hours

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Access to notes on a tablet; Participants will be provided a tablet and will be able to access their child's medical notes while in the hospital.	Other: Access to medical notes; Inpatient notes shared in real-time on a hospital-owned bedside tablet linked to their child's records.
No Intervention: Care as usual; Participants will not have access to a table to view their child's medical notes while in the hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of notes accessed	Researchers will abstract note access during hospitalization from the EHR and compare the frequency and proportion of available notes accessed between arms.	Duration of study participation, 2 to 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety concern reporting	Safety concern reporting will be measured using the OpenNotes safety concern reporting tool, a 9-item questionnaire adapted for parent-reported safety concerns during hospitalization. The tool will be translated into Spanish and piloted for this study. Parent-reported safety concerns will be reviewed by the PI and site PIs and categorized as definite safety issues, possible safety issues, or other. Definite and possible issues will be further categorized by type (e.g., medication, physical exam) and assessed via chart reviews for associated changes to the medical record or patient care (yes/no/uncertain). Researchers will compare results across arms.	Duration of study participation, 2 to 7 days
Hospital experience	Experience will be measured using the Child Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey, which evaluates parent perceptions of their hospital experience upon discharge. The survey includes closed-ended and Likert-style items rated on a 5-point scale, with "strongly agree" as the highest score. Key measures include overall hospital rating, willingness to recommend, and "helping you report concerns." It is available in English and Spanish. It will be administered prior to hospital discharge and compared across arms.	Duration of study participation, 2 to 7 days
Change in parent activation	Activation will be measured using the Parent-Patient Activation Measure (P-PAM), a 13-item Likert-style tool adapted from the Patient Activation Measure (PAM), assessing skills and confidence for managing a child's healthcare. Scores range from 0-100, with higher scores indicating greater activation. The P-PAM has demonstrated validity and reliability in both English and Spanish. It will be administered at baseline and prior to hospital discharge and compared across arms.	Baseline to discharge, 2 to 7 days
Change in Anxiety	Anxiety will be measured using the State-Trait Anxiety Inventory (STAI) Form Y, a 40-item Likert-style questionnaire assessing anxiety on a 4-point scale. Total scores range from 20-80, with higher scores indicating greater anxiety. The STAI is validated for sensitivity to health interventions over time and is available in English and Spanish. It will be administered at baseline and prior to hospital discharge and compared across arms.	Baseline to discharge, 2 to 7 days

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: Agency for Healthcare Research and Quality (AHRQ); Pediatric Research in Inpatient Settings (PRIS) Network
• Investigators: Principal Investigator: Michelle Kelly, MD, PhD, University of Wisconsin, Madison

Publications and helpful links

General Publications

• O'Hare C, Gatewood AK, Baird J, Brown R, Coller RJ, Desai A, Egan A, Gerber D, McGuire T, Singh-Verdeflor KD, Smith CA, Verdelis GA, Warner G, Wong S, Kelly MM. A multicenter randomized trial to improve family clinical note access and outcomes for hospitalized children: The Bedside Notes study protocol. J Hosp Med. 2025 Nov;20(11):1256-1264. doi: 10.1002/jhm.70155. Epub 2025 Aug 21.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: December 3, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Actual): December 9, 2024

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Quality Improvement; Family-Centered Care; Electronic Health Records (EHR); Safety Reporting; Parent Note Access
• Other Study ID Numbers: 2024-1396; A536771 (Other Identifier: UW Madison); 1R01HS030098-01 (U.S. AHRQ Grant/Contract); Protocol Version 2/6/2025 (Other Identifier: UW Madison)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No