A Trial to Improve Family Clinical Note Access and Outcomes for Hospitalized Children
NCT ID: NCT06722378
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
630 participants
INTERVENTIONAL
2025-04-01
2029-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Access to medical notes
Inpatient notes shared in real-time on a hospital-owned bedside tablet linked to their child's records.
Care as usual
Participants will not have access to a table to view their child's medical notes while in the hospital.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Access to medical notes
Inpatient notes shared in real-time on a hospital-owned bedside tablet linked to their child's records.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age 18 and over
Exclusion Criteria
* Parents unable to give written informed consent
* Parents of children admitted for suspected abuse or neglect
* Anticipated discharge within 24 hours
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Agency for Healthcare Research and Quality (AHRQ)
FED
Pediatric Research in Inpatient Settings (PRIS) Network
UNKNOWN
University of Wisconsin, Madison
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michelle Kelly, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Children's Hospital of Los Angeles
Los Angeles, California, United States
Seattle Children's Hospital
Seattle, Washington, United States
American Family Children's Hospital
Madison, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Protocol Version 2/6/2025
Identifier Type: OTHER
Identifier Source: secondary_id
A536771
Identifier Type: OTHER
Identifier Source: secondary_id
2024-1396
Identifier Type: -
Identifier Source: org_study_id