Starzl Network Patient Reported Outcomes

Quality of Life Clinical Trial

— SPaRO  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05241847
• Other study ID #: STUDY21090139
• Secondary ID: U18HS028380-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 28, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: April 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 202
• Est. completion date: July 31, 2024
• Est. primary completion date: March 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 20 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• PeLTQL delivery via electronic means
Delivery of PeLTQL scoring information to clinicians via electronic means.

Locations

Country	Name	City	State
Canada	Toronto Sick Kids	Toronto	Ontario
United States	Emory Children's	Atlanta	Georgia
United States	Columbia University Children's	New York	New York
United States	Mt. Sinai	New York	New York
United States	UCSF Benioff Children's Hospital	Oakland	California
United States	UPMC Children's	Pittsburgh	Pennsylvania
United States	Seattle Children's	Seattle	Washington

Sponsors (7)

Lead Sponsor	Collaborator
University of Pittsburgh	Columbia University, Emory-Children's Center, Icahn School of Medicine at Mount Sinai, Seattle Children's Hospital, The Hospital for Sick Children, University of San Francisco

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rejection	Incidence of rejection of the transplanted liver	24 months
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	Implementation metric	Percentage of patient-proxy dyads (amongst all enrolled) who completed the PeLTQL at least once.	18 months
Secondary	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

External Links

•   Starzl Network Main Website