Starzl Network Patient Reported Outcomes

Study Overview
=================
Brief 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.

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.

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

Conditions
-----------------
Liver Transplant; Complications, Quality of Life, Child Behavior, Adolescent Behavior

Intervention / Treatment
-----------------
* Behavioral: PeLTQL delivery via electronic means


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient must meet all of below criteria to be eligible for enrollment in the study: The patient is > 8 at enrollment and < 20 years of age at 2 year post enrollment. The patient received a liver transplantation at least 1 year prior to enrollment. The patient and parent/ guardian have internet access either through a smartphone, tablet or computer. 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: The patient is expected to transition to another service (e.g., adult clinic, another hospital) in the year following enrollment. 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.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm interventional trial with use of the RTC mobile application representing the intervention of interest
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pediatric liver transplant recipients<br>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<br>* Delivery of PeLTQL scoring information to clinicians via electronic means.<br>* 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 | 
| Baseline medication level variability index (MLVI) | Degree of fluctuation in immunosuppressant medication levels. Higher MLVI =worse adherence to medication. | Calculated for year prior to enrollment (12 month period prior to 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
quality of life