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

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ClinicalTrials.gov Identifier: NCT02491190
Recruitment Status : Completed
First Posted : July 7, 2015
Last Update Posted : May 16, 2016
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Inpatient Pediatric Engagement and Shared Decision-Making Behavioral: EMPOWER Educational Module Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Health Services Research
Official Title: Using Multimedia Digital Health to Enable and Engage Pediatric Inpatients and Their Parents: A Pilot Study
Study Start Date : August 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : March 2016

Arm Intervention/treatment
Experimental: Treatment
Empower educational module: After the patient activation measure/s are collected, for parents or patients assigned to the intervention arm, they will be given an opportunity to launch the EMPOWER video and interactive powerpoint. They will be able to pause on reviewing the educational material and come back to it, as with other assigned education, and they will be able to review it again if they would like. Discharge surveys will be assigned 24 hours prior to the estimated discharge time in Apex. Oneview will display notifications that the surveys have been assigned.
Behavioral: EMPOWER Educational Module
Evidence-based video module delivering content of the Right Question intervention from Deen et al. (2011)

No Intervention: Control
Standard care: Those who opt to participate in the study will be randomly assigned to receive standard features of the media center (control group), or standard features plus the educational module intervention. They will complete online (1) a baseline patient activation survey (for patients old enough to complete and for caregivers) at the start of their participation, and (2) an end-of-study survey pre-discharge or at the end of the study period.



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 95 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02491190


Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Naomi S. Bardach, MD, MAS University of California, San Francisco
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02491190    
Other Study ID Numbers: 15-16151
First Posted: July 7, 2015    Key Record Dates
Last Update Posted: May 16, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No