Summary

Eligibility
for people ages 8-20 (full criteria)
Location
at UCSF
Dates
study started
estimated completion
Principal Investigator
by Emily Perito, MD (ucsf)
Headshot of Emily Perito
Emily Perito

Description

Summary

This study uses a smartphone application/web interface (RealTime Clinic; RTC) to collect patient and parent reports of a pediatric liver transplant recipient's quality of life (QOL), and examines the extent to which QOL evaluations can be integrated into care with the help of the application. The QOL measure that is used in this study is the Pediatric Liver Transplant Quality of Life (PeLTQL) questionnaire. Utilization, effectiveness, and efficiency data are evaluated. Hypotheses are fully described in the protocol. The primary hypothesis is that 80% of recruited child-proxy dyads will have at least one RTC-enabled PeLTQL score at 12 months. Other hypotheses look at implementation metrics and patient outcomes.

Official Title

Starzl Network for Excellence in Pediatric Transplantation (SNEPT) Implementation of a QoL Measure in Pediatric Transplant Recipients

Details

Despite evidence supporting the benefits of QOL assessments and the availability of many QOL assessment instruments, the integration of these instruments into clinical practice has not yet become standard of care. The Pediatric Liver Transplant Quality of Life (PeLTQL), the study measure, is a condition-specific 26-item questionnaire; the investigators will be evaluating both total scores as well as subdomain scores and, importantly, discrepancies between child and parent reports of the child's QOL. The Electronic Platform: Real-Time Clinic (RTC). The platform will furnish providers with the total scores, subscale scores, thresholds ("met" vs. "not met"), discrepancy scores, and any question that has scores which may concern the clinician/clinical team. This information will be available before the clinic visit and can guide and inform discussion and problem-solving between patient and clinical team. The study does not standardize the response to the results and will not suggest a preferred way of action. Interpretation of the results, as well as actions related to them are completely left to clinician's discretion. The setting of this study - the Starzl Network for Excellence in Pediatric Transplantation (SNEPT Centers). SNEPT is a learning healthcare network that was established in 2018 to accelerate improvement in transplant outcomes by incorporating innovation, technology and the patient voice to address gaps in care that were identified by the collaborative transplant centers and family representatives. Study Aims The primary aim is successful implementation of the RTC app-based tool to obtain PeLTQL scores from pediatric liver transplant recipients and their parents or caregivers. The investigators also aim to assess the usability, impact, and ease of use (both for clinicians and patients/families) of the RTC platform and app-based version of the PeLTQL. The investigators will evaluate clinicians' subjective views on the platforms' ease of use, their time spent evaluating results, both in clinic and before patient visits, as well as the app's impact on back-end clinic workflow. Impact on patient outcomes will be evaluated using pre-post comparisons on adherence (determined by the objective medication level variability index, MLVI) as well as on the PeLTQL.

Keywords

Liver Transplant; Complications Quality of Life Child Behavior Adolescent Behavior PeLTQL delivery via electronic means Pediatric liver transplant recipients

Eligibility

You can join if…

Open to people ages 8-20

The patient must meet all of below criteria to be eligible for enrollment in the study:

  1. The patient is > 8 at enrollment and < 20 years of age at 2 year post enrollment.
  2. The patient received a liver transplantation at least 1 year prior to enrollment.
  3. The patient and parent/ guardian have internet access either through a smartphone, tablet or computer.
  4. The patient and at least one guardian speaks English or Spanish at a level that allows them to understand the study procedures and consent to the study.

You CAN'T join if...

None of the following may be present if the patient is to be eligible for enrollment in the study:

  1. The patient is expected to transition to another service (e.g., adult clinic, another hospital) in the year following enrollment.
  2. The guardian or patient (in a developmentally-appropriate manner) do not understand the study procedures. This will be verified by asking both guardian and adolescent to repeat the study procedures.

Locations

  • UCSF Benioff Children's Hospital accepting new patients
    Oakland California 94609 United States
  • Seattle Children's accepting new patients
    Seattle Washington 98105 United States

Lead Scientist at University of California Health

  • Emily Perito, MD (ucsf)
    Dr. Emily R. Perito is an associate professor at UCSF who specializes in pediatric liver and pancreatic disease, pediatric liver transplant, and pediatric gastroenterology. She is jointly appointed in the Departments of Pediatrics and of Epidemiology and Biostatistics. She is board-certified in pediatrics, pediatric gastroenterology, and pediatric transplant hepatology.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Pittsburgh
Links
Starzl Network Main Website
ID
NCT05241847
Study Type
Interventional
Participants
Expecting 300 study participants
Last Updated