Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Starzl Network Patient Reported Outcomes (SPaRO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05241847
Recruitment Status : Recruiting
First Posted : February 16, 2022
Last Update Posted : June 3, 2022
Sponsor:
Collaborators:
Icahn School of Medicine at Mount Sinai
The Hospital for Sick Children
Emory-Children's Center
Columbia University
Seattle Children's Hospital
University of San Francisco
Information provided by (Responsible Party):
George Mazariegos, University of Pittsburgh

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.


Condition or disease Intervention/treatment Phase
Liver Transplant; Complications Quality of Life Child Behavior Adolescent Behavior Behavioral: PeLTQL delivery via electronic means Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm interventional trial with use of the RTC mobile application representing the intervention of interest
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Starzl Network for Excellence in Pediatric Transplantation (SNEPT) Implementation of a QoL Measure in Pediatric Transplant Recipients
Actual Study Start Date : February 28, 2022
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : July 31, 2024

Resource links provided by the National Library of Medicine


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 Name: Real Time Clinic mobile application




Primary Outcome Measures :
  1. Implementation metric [ Time Frame: 12 months ]
    The proportion of participants who complete the Pediatric Liver Transplant Quality of Life (PeLTQL) measure (either parent or child), at least once


Secondary Outcome Measures :
  1. Patient baseline quality of life (child report on PeLTQL) [ Time Frame: Time of enrollment ]
    PeLTQL = Pediatric Liver Transplant Quality of Life questionnaire. Range of scores (after transformation), range (0-100) Higher score = Better QoL

  2. Patient quality of life (child report on PeLTQL) [ Time Frame: 12 months post-enrollment ]
    PeLTQL = Pediatric Liver Transplant Quality of Life questionnaire. Range of scores (after transformation), range (0-100) Higher score = Better QoL

  3. Proxy report of child's quality of life using PeLTQL [ Time Frame: Time of enrollment ]
    PeLTQL = Pediatric Liver Transplant Quality of Life questionnaire. Range of scores (after transformation), range (0-100) Higher score = Better QoL

  4. Proxy report of child's quality of life using PeLTQL [ Time Frame: 12 months post-enrollment ]
    PeLTQL = Pediatric Liver Transplant Quality of Life questionnaire. Range of scores (after transformation), range (0-100) Higher score = Better QoL

  5. Baseline medication level variability index (MLVI) [ Time Frame: Calculated for year prior to enrollment (12 month period prior to enrollment) ]
    Degree of fluctuation in immunosuppressant medication levels. Higher MLVI =worse adherence to medication.

  6. Medication level variability index (MLVI) [ Time Frame: Calculated for year following implementation (12 month period following enrollment) ]
    Degree of fluctuation in immunosuppressant medication levels. Higher MLVI =worse adherence to medication.

  7. PeLTQL discrepancy score [ Time Frame: First administration of PeLTQL in year 1 ]
    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

  8. PeLTQL discrepancy score [ Time Frame: Second administration of PeLTQL within 24 months ]
    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

  9. Implementation metric [ Time Frame: 18 months ]
    Percentage of patient-proxy dyads (amongst all enrolled) who completed the PeLTQL at least once.

  10. Implementation metric [ Time Frame: 24 months ]
    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.


Other Outcome Measures:
  1. Rejection [ Time Frame: 24 months ]
    Incidence of rejection of the transplanted liver



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   8 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05241847


Contacts
Layout table for location contacts
Contact: George Mazariegos, MD 4126926110 george.mazariegos@chp.edu
Contact: Daniel W Pieratt 4126926692 pierattdw@upmc.edu

Locations
Layout table for location information
United States, California
UCSF Benioff Children's Hospital Recruiting
Oakland, California, United States, 94609
Contact: Alejandra Alvarado, MD       alejandra.alvarado@ucsf.edu   
Principal Investigator: Emily Perito, MD         
United States, Georgia
Emory Children's Not yet recruiting
Atlanta, Georgia, United States, 30322
Contact: Angela Stallworth, MD       angela.stallworth@choa.org   
Principal Investigator: Nitika Gupta, MD         
United States, New York
Columbia University Children's Recruiting
New York, New York, United States, 10027
Contact: Bo Lu       bl2699@cumc.edu   
Principal Investigator: Steven Lobritto, MD         
Mt. Sinai Recruiting
New York, New York, United States, 10029
Contact: Claire Dunphy, Ph.D       claire.dunphy@mssm.edu   
Contact: Ragene Walker       ragen.walker@mssm.edu   
Principal Investigator: Eyal Shemesh, Ph.D         
United States, Pennsylvania
UPMC Children's Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Daniel Pieratt, MPA       pierattdw@upmc.edu   
Principal Investigator: George Mazariegos, MD         
United States, Washington
Seattle Children's Recruiting
Seattle, Washington, United States, 98105
Contact: Melissa Young, MD       melissa.young@seattlechildrens.org   
Principal Investigator: Evelyn Hsu, MD         
Canada, Ontario
Toronto Sick Kids Recruiting
Toronto, Ontario, Canada, 10001
Contact: Daniel Miller, MPH       daniel.miller@sickkids.ca   
Principal Investigator: Vicky Ng, MD         
Sponsors and Collaborators
University of Pittsburgh
Icahn School of Medicine at Mount Sinai
The Hospital for Sick Children
Emory-Children's Center
Columbia University
Seattle Children's Hospital
University of San Francisco
Investigators
Layout table for investigator information
Principal Investigator: Eyal Shemesh, MD Icahn School of Medicine at Mt. Sinai
Principal Investigator: George Mazariegos, MD University of Pittsburgh
Additional Information:
Publications:
Layout table for additonal information
Responsible Party: George Mazariegos, Professor of Surgery, Chief Pediatric Transplantation, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT05241847    
Other Study ID Numbers: STUDY21090139
U18HS028380-01 ( U.S. AHRQ Grant/Contract )
First Posted: February 16, 2022    Key Record Dates
Last Update Posted: June 3, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by George Mazariegos, University of Pittsburgh:
quality of life