Starzl Network for Excellence in Pediatric Transplantation (SNEPT) Implementation of a QoL Measure in Pediatric Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 13
- 主要终点
- Implementation metric
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Implementation metric
时间窗: 12 months
The proportion of participants who complete the Pediatric Liver Transplant Quality of Life (PeLTQL) measure (either parent or child), at least once
次要结局
- Patient quality of life (child report on PeLTQL)(12 months post-enrollment)
- Patient baseline quality of life (child report on PeLTQL)(Time of enrollment)
- Proxy report of child's quality of life using PeLTQL(12 months post-enrollment)
- Implementation metric(24 months)
- Medication level variability index (MLVI)(Calculated for year following implementation (12 month period following enrollment))
- PeLTQL discrepancy score(Second administration of PeLTQL within 24 months)
- Proxy report of child's quality of life using PeLTQL(Time of enrollment)
- PeLTQL discrepancy score(First administration of PeLTQL in year 1)
- Implementation metric(18 months)
研究者
George Mazariegos
Professor of Surgery, Chief Pediatric Transplantation
University of Pittsburgh