Clinical trial NCT02491190: Using Multimedia Digital Health to Enable and Engage Pediatric Inpatients and Their Parents
Official title: Using Multimedia Digital Health to Enable and Engage Pediatric Inpatients and Their Parents: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inpatient Pediatric Engagement and Shared Decision-Making
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2015-07-07
Enrollment: 58
Sex: ALL
Maximum age (years): 95
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change in activation as measured with the Parent Patient Activation Measure (PPAM)
timeFrame: 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:
measure: Quality of Shared Decision-Making measured using the CollaboRATE 3-item scale
timeFrame: Measured at discharge, an average of 3 days after study enrollment
measure: Quality of Shared Decision-Making measured using M-PICS scores
timeFrame: Measured at discharge, an average of 3 days after study enrollment
measure: Length of Stay obtained from the Epic electronic health record
timeFrame: Measured at discharge, an average of 3 days after study enrollment
measure: 30-day readmission obtained from the Epic electronic health record
timeFrame: Measured 30 days after discharge. Discharge occurs an average of 3 days after study enrollment
measure: Study Recruitment Rate
timeFrame: Baseline
measure: Study Retention
timeFrame: Measured at discharge, an average of 3 days after study enrollment
measure: Engagement with the Educational Module
timeFrame: Duration of the hospital stay, an average of 3 days
measure: Repeated Engagement with the Education Module
timeFrame: Duration of the hospital stay, an average of 3 days
Other outcomes:
Locations:
Study officials:
affiliation: University of California, San Francisco
name: Naomi S. Bardach, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pennarola BW, Rodday AM, Mayer DK, Ratichek SJ, Davies SM, Syrjala KL, Patel S, Bingen K, Kupst MJ, Schwartz L, Guinan EC, Hibbard JH, Parsons SK; HSCT-CHESS Study. Factors associated with parental activation in pediatric hematopoietic stem cell transplant. Med Care Res Rev. 2012 Apr;69(2):194-214. doi: 10.1177/1077558711431460. Epub 2011 Dec 26.
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citation: Smith MY, Winkel G, Egert J, Diaz-Wionczek M, DuHamel KN. Patient-physician communication in the context of persistent pain: validation of a modified version of the patients' Perceived Involvement in Care Scale. J Pain Symptom Manage. 2006 Jul;32(1):71-81. doi: 10.1016/j.jpainsymman.2006.01.007.
citation: Alegria M, Sribney W, Perez D, Laderman M, Keefe K. The role of patient activation on patient-provider communication and quality of care for US and foreign born Latino patients. J Gen Intern Med. 2009 Nov;24 Suppl 3(Suppl 3):534-41. doi: 10.1007/s11606-009-1074-x.
citation: Hibbard JH, Mahoney ER, Stockard J, Tusler M. Development and testing of a short form of the patient activation measure. Health Serv Res. 2005 Dec;40(6 Pt 1):1918-30. doi: 10.1111/j.1475-6773.2005.00438.x.
citation: Barr PJ, Thompson R, Walsh T, Grande SW, Ozanne EM, Elwyn G. The psychometric properties of CollaboRATE: a fast and frugal patient-reported measure of the shared decision-making process. J Med Internet Res. 2014 Jan 3;16(1):e2. doi: 10.2196/jmir.3085.
citation: Bardach NS, Lam R, Jasik CB. Assessment of automated clinical trial recruitment and enrolment using patient-facing technology. BMJ Health Care Inform. 2021 Jan;28(1):e100076. doi: 10.1136/bmjhci-2019-100076.