Starzl Network Patient Reported Outcomes

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.

Conditions

• Liver Transplant; Complications
• Quality of Life
• Child Behavior
• Adolescent Behavior

Interventions

BEHAVIORAL

PeLTQL delivery via electronic means

Delivery of PeLTQL scoring information to clinicians via electronic means.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai

  collaborator OTHER

• The Hospital for Sick Children

  collaborator OTHER

• Emory-Children's Center

  collaborator OTHER

• Columbia University

  collaborator OTHER

• Seattle Children's Hospital

  collaborator OTHER

• University of San Francisco

  collaborator OTHER

• University of Pittsburgh

  lead OTHER

Principal Investigators

• Eyal Shemesh, MD · Icahn School of Medicine at Mt. Sinai

• George Mazariegos, MD · University of Pittsburgh

Study Design

Allocation

NA

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

8 Years

Max Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-02-28

Primary Completion

2024-03-20

Completion

2025-07-30

Countries

• United States
• Canada

Study Locations