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Completed

NCT Number: NCT02491190

Using Multimedia Digital Health to Enable and Engage Pediatric Inpatients and Their Parents

This project leverages digital health technology to support patient engagement and shared decision-making between families, patients, and providers. The investigators will start by finalizing the educational module and adding randomization for the trial (Aim 1). The investigators will then complete iterative user testing in the live system through measurement of educational module views and usability feedback interviews with 20 end users (Aim 2). The investigators will then conduct a randomized controlled trial to test the impact of the educational module on existing measures of patient engagement (Aim 3). The hypothesis is that parents who receive the educational module will have higher scores on shared decision-making, patient activation and overall patient experience.

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Key information

Conditions

Inpatient Pediatric Engagement and Shared Decision-Making

Age range

Up to 95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Hospitals are not consistently patient centered, contributing to worse outcomes and a sense of loss of control. Prior interventions that promote patient-centered care focused on provider and hospital factors vs. engaging patients directly. No project to date has capitalized on digital health technology to engage families in shared decision-making and patient engagement. The goal of the proposed randomized controlled trial is to test the impact of an evidence-based educational module delivered using an interactive patient-facing IT platform, on measures of patient engagement and shared decision-making. The platform was developed for the UCSF Benioff Children's Hospital by OneView, Inc. and includes an educational module that promotes shared decision-making through orientation to the hospital and evidence-based teaching on engaging with providers. This study will provide pilot data for a large-scale trial measuring the impact of the system on patient engagement. The investigators will start by finalizing the educational module and adding randomization for the trial (Aim 1). The investigators will then complete iterative user testing in the live system through measurement of educational module views and usability feedback interviews with 20 end users (Aim 2). The investigators will then conduct a randomized controlled trial to test the impact of the educational module on existing measures of patient engagement (Aim 3). Our hypothesis is that parents who receive the educational module will have higher scores on shared decision-making, patient activation and overall patient experience. The eligible study population is all pediatric and newborn inpatients and their caregivers from June 2015 - August 2015. The investigators anticipate needing a sample size of 100, 50 in each arm. This pilot will generate key information on the platform's feasibility and acceptability and initial data on effect sizes to power future large-scale grants.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • An admitted patient (up to age 22) or caregiver (up to 95) of an admitted patient at Benioff Children's Hospital in the acute care units, the pediatric hematology-oncology units, or the transitional care units, admitted to the hospital within the past 72 hours.

Exclusion criteria

  • Was already admitted and discharged during the study period.
  • Not an English speaker.
  • Not having a parent or legal guardian present or available by phone to give consent for those <18 years of age.
  • Patient is in foster care.

Treatment and study plan

EMPOWER Educational Module

Behavioral

Evidence-based video module delivering content of the Right Question intervention from Deen et al. (2011)

Primary outcomes

  1. Change in activation as measured with the Parent Patient Activation Measure (PPAM)

    Time frame: Measured at enrollment, and at hospital discharge--duration of hospital stay is an average of 3 days. Calculated as change in PPAM scores.

Secondary outcomes

  1. Quality of Shared Decision-Making measured using the CollaboRATE 3-item scale

    Time frame: Measured at discharge, an average of 3 days after study enrollment

  2. Quality of Shared Decision-Making measured using M-PICS scores

    Time frame: Measured at discharge, an average of 3 days after study enrollment

  3. Length of Stay obtained from the Epic electronic health record

    Time frame: Measured at discharge, an average of 3 days after study enrollment

  4. 30-day readmission obtained from the Epic electronic health record

    Time frame: Measured 30 days after discharge. Discharge occurs an average of 3 days after study enrollment

    This is a binary measure assessing whether the patient was readmitted to the hospital (Benioff Children' Hospital) within 30 days after discharge date.

  5. Study Recruitment Rate

    Time frame: Baseline

    Number of patients with at least one person agreeing to participate (either a family member or a child) / Number of eligible patients who were assigned the study introduction materials in the hospital electronic educational center

  6. Study Retention

    Time frame: Measured at discharge, an average of 3 days after study enrollment

    Number of participants who complete the survey capturing the second patient activation measure prior to hospital discharge / Number of participants who completed the first Patient Activation Measure

  7. Engagement with the Educational Module

    Time frame: Duration of the hospital stay, an average of 3 days

    Number of participants viewing the EMPOWER educational module (intervention) at least once / Number of patients assigned the module. Data from the OneView system

  8. Repeated Engagement with the Education Module

    Time frame: Duration of the hospital stay, an average of 3 days

    Number of views of the educational module for participants who viewed it at least once

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Using Multimedia Digital Health to Enable and Engage Pediatric Inpatients and Their Parents: A Pilot Study

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 7, 2015
Registry last updated
May 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.