Hospitalized ChildNCT06722378
A Trial to Improve Family Clinical Note Access and Outcomes for Hospitalized Children
A study testing Access to medical notes in people with Hospitalized Child and Pediatric Patient Safety, run by University of Wisconsin, Madison at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospitalized Child, Pediatric Patient Safety, Medical Errors
- What is being tested?
- Access to medical notes
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 630 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Apr 2025to Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Amanda Gatewood contact
United States3 sites, 3 recruiting
- Recruiting
Children's Hospital of Los Angeles
Los Angeles, California, 90027
Anna Egan, MD
- Recruiting
American Family Children's Hospital
Madison, Wisconsin, 53792
Michelle Kelly, MD, PhD
Ryan Coller, MD, MPH
- Not yet recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Arti Desai, MD
About this study
Official title: 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
Read the 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.
- Conditions
- Hospitalized Child, Pediatric Patient Safety, Medical Errors, Parental Engagement in Care, Inpatient Pediatric Care
- Being tested
- Access to medical notes
- Keywords
- Family-Centered Care, Electronic Health Records (EHR), Safety Reporting, Parent Note Access, Quality Improvement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access to medical notesOther
Inpatient notes shared in real-time on a hospital-owned bedside tablet linked to their child's records.
| Study group | Role | What they receive |
|---|---|---|
| Access to notes on a tablet | Experimental | Participants will be provided a tablet and will be able to access their child's medical notes while in the hospital. Receives: Other: Access to medical notes |
| Care as usual | No intervention | Participants will not have access to a table to view their child's medical notes while in the hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Duration of study participation, 2 to 7 days
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to discharge, 2 to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start1 Apr 2025
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hospitalized ChildStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 630 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Pediatric Research in Inpatient Settings (PRIS) Network
- Responsible party
- Sponsor
- Investigators
- Michelle Kelly, MD, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06722378
- Sponsor's protocol ID
- 2024-1396
- Other IDs
- 1R01HS030098-01, Protocol Version 2/6/2025, A536771
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2024
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 40839550
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bedside Notes: A Multicenter Trial to Improve Family Clinical Note Access and Outcomes for Hospitalized Children
- ClinicalTrials.gov ID
- NCT06722378
- Acronym / sponsor ID
- 2024-1396
- Conditions
- Hospitalized Child, Pediatric Patient Safety, Medical Errors, Parental Engagement in Care, Inpatient Pediatric Care
- Keywords
- Family-Centered Care, Electronic Health Records (EHR), Safety Reporting, Parent Note Access, Quality Improvement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 630 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Pediatric Research in Inpatient Settings (PRIS) Network
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Access to notes on a tablet | Experimental | Other: Access to medical notesParticipants will be provided a tablet and will be able to access their child's medical notes while in the hospital. |
| Care as usual | No intervention | –Participants will not have access to a table to view their child's medical notes while in the hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Access to medical notesInpatient notes shared in real-time on a hospital-owned bedside tablet linked to their child's records. | Other | Access to notes on a tablet |
Primary outcome
Number of notes accessed
Time frame: Duration of study participation, 2 to 7 days
Researchers will abstract note access during hospitalization from the EHR and compare the frequency and proportion of available notes accessed between arms.
4 secondary outcomes
Safety concern reporting
Time frame: Duration of study participation, 2 to 7 days
Hospital experience
Time frame: Duration of study participation, 2 to 7 days
Change in parent activation
Time frame: Baseline to discharge, 2 to 7 days
Change in Anxiety
Time frame: Baseline to discharge, 2 to 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Background: PubMed 40839550O'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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amanda Gatewood contact
Michelle Kelly, MD, PhD principal investigator
University of Wisconsin, Madison
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Access to medical notes in people with Hospitalized Child and Pediatric Patient Safety, run by University of Wisconsin, Madison at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle Kelly, MD, PhD ((608) 265-5545, michelle.kelly@wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of notes accessed (time frame: Duration of study participation, 2 to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06722378, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.