Clinical trial NCT06722378: A Trial to Improve Family Clinical Note Access and Outcomes for Hospitalized Children
Official title: Bedside Notes: A Multicenter Trial to Improve Family Clinical Note Access and Outcomes for Hospitalized Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
name: Pediatric Research in Inpatient Settings (PRIS) Network
First posted: 2024-12-09
Enrollment: 630
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of notes accessed
timeFrame: Duration of study participation, 2 to 7 days
Secondary outcomes:
measure: Safety concern reporting
timeFrame: Duration of study participation, 2 to 7 days
measure: Safety climate
timeFrame: Duration of study participation, 2 to 7 days
measure: Hospital experience
timeFrame: Duration of study participation, 2 to 7 days
measure: Change in parent activation
timeFrame: Baseline to discharge, 2 to 7 days
measure: Change in Anxiety
timeFrame: Baseline to discharge, 2 to 7 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles
state: California
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Madison
country: United States
facility: American Family Children's Hospital
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Michelle Kelly, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: