Starzl Network Patient Reported Outcomes (SPaRO)

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Child Behavior; Liver Transplant; Complications; Adolescent Behavior
• Intervention / Treatment: Behavioral: PeLTQL delivery via electronic means

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, 10001
      • Toronto Sick Kids
• United States
  • California
    • Oakland, California, United States, 94609
      • UCSF Benioff Children's Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory Children's
  • New York
    • New York, New York, United States, 10029
      • Mt. Sinai
    • New York, New York, United States, 10027
      • Columbia University Children's
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • UPMC Children's
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pediatric liver transplant recipients; As this is a single arm trial, all eligible liver transplant recipients and their caregivers will be enrolled in this arm. Eligible participants are children who received a liver transplant at least 1 year prior to enrollment at a participating SNEPT center and continue to receive their post-transplant care at that center.	Behavioral: PeLTQL delivery via electronic means; Delivery of PeLTQL scoring information to clinicians via electronic means.; Other Names: Real Time Clinic mobile application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implementation metric	The proportion of participants who complete the Pediatric Liver Transplant Quality of Life (PeLTQL) measure (either parent or child), at least once	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient baseline quality of life (child report on PeLTQL)	PeLTQL = Pediatric Liver Transplant Quality of Life questionnaire. Range of scores (after transformation), range (0-100) Higher score = Better QoL	Time of enrollment
Patient quality of life (child report on PeLTQL)	PeLTQL = Pediatric Liver Transplant Quality of Life questionnaire. Range of scores (after transformation), range (0-100) Higher score = Better QoL	12 months post-enrollment
Proxy report of child's quality of life using PeLTQL	PeLTQL = Pediatric Liver Transplant Quality of Life questionnaire. Range of scores (after transformation), range (0-100) Higher score = Better QoL	Time of enrollment
Proxy report of child's quality of life using PeLTQL	PeLTQL = Pediatric Liver Transplant Quality of Life questionnaire. Range of scores (after transformation), range (0-100) Higher score = Better QoL	12 months post-enrollment
Medication level variability index (MLVI)	Degree of fluctuation in immunosuppressant medication levels. Higher MLVI =worse adherence to medication.	Calculated for year following implementation (12 month period following enrollment)
PeLTQL discrepancy score	The discrepancy score is defined as the parent score minus the child's score on the PELTQL. PeLTQL = Pediatric Liver Transplant Quality of Life questionnaire	First administration of PeLTQL in year 1
PeLTQL discrepancy score	The discrepancy score is defined as the parent score minus the child's score on the PELTQL. PeLTQL = Pediatric Liver Transplant Quality of Life questionnaire	Second administration of PeLTQL within 24 months
Implementation metric	Percentage of patient-proxy dyads (amongst all enrolled) who completed the PeLTQL at least once.	18 months
Implementation metric	Percentage of participating parent-child dyads (amongst all dyads) in which both the parent and the child completed one or more questionnaires during the study period.	24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rejection	Incidence of rejection of the transplanted liver	24 months

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: The Hospital for Sick Children; Columbia University; Icahn School of Medicine at Mount Sinai; Seattle Children's Hospital; Emory-Children's Center; University of San Francisco
• Investigators: Principal Investigator: Eyal Shemesh, MD, Icahn School of Medicine at Mt. Sinai; Principal Investigator: George Mazariegos, MD, University of Pittsburgh

Publications and helpful links

General Publications

• Ng V, Nicholas D, Dhawan A, Yazigi N, Ee L, Stormon M, Gilmour S, Schreiber R, Taylor R, Otley A; PeLTQL study group. Development and validation of the pediatric liver transplantation quality of life: a disease-specific quality of life measure for pediatric liver transplant recipients. J Pediatr. 2014 Sep;165(3):547-55.e7. doi: 10.1016/j.jpeds.2014.05.024. Epub 2014 Jun 26.

Helpful Links

• Starzl Network Main Website

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2022
• Primary Completion (Actual): March 20, 2024
• Study Completion (Actual): July 30, 2025

Study Registration Dates

• First Submitted: January 22, 2022
• First Submitted That Met QC Criteria: February 4, 2022
• First Posted (Actual): February 16, 2022

Study Record Updates

• Last Update Posted (Estimated): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: quality of life
• Additional Relevant MeSH Terms: Behavior; Child Behavior; Adolescent Behavior
• Other Study ID Numbers: STUDY21090139; U18HS028380-01 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No