Starzl Network Patient Reported Outcomes (SPaRO)
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| ClinicalTrials.gov Identifier: NCT05241847 |
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Recruitment Status :
Recruiting
First Posted : February 16, 2022
Last Update Posted : February 21, 2023
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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 |
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 (Clinical Trial) |
| Estimated Enrollment : | 200 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 |
| Arm | Intervention/treatment |
|---|---|
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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 |
- 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
- 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
- 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
- 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
- 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
- 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.
- 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.
- 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
- 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
- Implementation metric [ Time Frame: 18 months ]Percentage of patient-proxy dyads (amongst all enrolled) who completed the PeLTQL at least once.
- 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.
- Rejection [ Time Frame: 24 months ]Incidence of rejection of the transplanted liver
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.
| Ages Eligible for Study: | 8 Years to 20 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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
| Contact: George Mazariegos, MD | 4126926110 | george.mazariegos@chp.edu | |
| Contact: Daniel W Pieratt | 4126926692 | pierattdw@upmc.edu |
| 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 | 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 | |
| Principal Investigator: | Eyal Shemesh, MD | Icahn School of Medicine at Mt. Sinai | |
| Principal Investigator: | George Mazariegos, MD | University of Pittsburgh |
Publications:
| 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: | February 21, 2023 |
| Last Verified: | February 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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quality of life |