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
4 other identifiers
interventional
630
1 country
3
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2025
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2024
CompletedFirst Posted
Study publicly available on registry
December 9, 2024
CompletedStudy Start
First participant enrolled
April 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2029
December 18, 2025
December 1, 2025
4 years
December 3, 2024
December 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Safety concern reporting
Duration of study participation, 2 to 7 days
Hospital experience
Duration of study participation, 2 to 7 days
Change in parent activation
Baseline to discharge, 2 to 7 days
Change in Anxiety
Baseline to discharge, 2 to 7 days
Study Arms (2)
Access to notes on a tablet
EXPERIMENTALParticipants will be provided a tablet and will be able to access their child's medical notes while in the hospital.
Care as usual
NO INTERVENTIONParticipants will not have access to a table to view their child's medical notes while in the hospital.
Interventions
Inpatient notes shared in real-time on a hospital-owned bedside tablet linked to their child's records.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Children's Hospital of Los Angeles
Los Angeles, California, 90027, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
American Family Children's Hospital
Madison, Wisconsin, 53792, United States
Related Publications (1)
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.
PMID: 40839550BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Michelle Kelly, MD, PhD
University of Wisconsin, Madison
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2024
First Posted
December 9, 2024
Study Start
April 1, 2025
Primary Completion (Estimated)
April 1, 2029
Study Completion (Estimated)
April 1, 2029
Last Updated
December 18, 2025
Record last verified: 2025-12