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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Wisconsin, Madison

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Access to medical notes

    Other intervention

    Inpatient notes shared in real-time on a hospital-owned bedside tablet linked to their child's records.

Treatment groups

630 Participants
are divided into 2 treatment groups
Group A: Access to notes on a tabletExperimental treatment 1 intervention
Group B: Care as usualNo intervention 0 interventions

Trial outcomes

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.

Time frame
Duration of study participation, 2 to 7 days

Secondary outcomes

1

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.

Time frame
Duration of study participation, 2 to 7 days
2

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.

Time frame
Duration of study participation, 2 to 7 days
3

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.

Time frame
Baseline to discharge, 2 to 7 days
4

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.

Time frame
Baseline to discharge, 2 to 7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Wisconsin, Madison

Lead sponsor

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Pediatric Research in Inpatient Settings (PRIS) Network

Collaborator