PInChPitt Innovation Challenge 2020

PInCh 2020 Finalists

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Transplants for Kids

Categories:
Pediatrics Hospital infrastructure Liver disease Organ donation Decision support Predictive Analytics Transplant outcomes
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Transplants for Kids

A software decision support solution that matches specific pediatric organ donor and recipient characteristics in real-time, saving time and reducing the deaths of children waiting for an organ transplant.

Highlights

  • Despite advancements in surgical technique and medical care, nearly 1,500 children have died on the wait list in the past 30 years because of inadequate matching of organs with needy recipients.

  • Transplants for Kids is a software solution that matches organ offers with decision support, with liver transplant as its first module because waitlist mortality demands action driving clinical change.

  • The prototype will be deployed in a commercially available platform (OmniLife) and disseminated nationally by a unique, transplant-focused learning health system - the Starzl Network

  • Building off success with liver transplant, other organ specific transplant modules will be expanded in children and then adults to impact thousands of transplant patients.

  • Transplants for Kids will save time for organ transplantation matches, lower waitlist mortality, increase transplant efficiency and transplant volume, and decrease payor costs.

Problem

Every year ~1,400 children await lifesaving organ transplants. When a precious organ does become available, decisions to proceed with transplant are complex, ultimately based on the alignment of transplant team experience, clinical assessment, and organ availability. Furthermore, optimal graft selection and wait list management strategies have not been fully developed or disseminated and while surgical expertise has evolved to mitigate the wait list crisis – the application of this knowledge has not occurred. Traditional methods have failed to change practice resulting in preventable deaths.

Critical to achieving optimal outcomes for this vulnerable population is the capacity to intervene in a timely manner with a suitable organ; yet, because the evaluation of organ offers is a difficult, non-standardized, and time-consuming process, over 75% of potential donor organ recoveries are unrealized. For the thousands of children who have waited for a transplant, dying while precious donor livers go unused or wasted is a tragedy.

Tools for the clinician at the bed side to confidently answer the question- “Is this donor offer best for my patient?” are lacking. Our solution changes that, providing clinicians with a data-driven approach to support optimal selection of organs for transplant while facilitating the communication process for every organ recovery.

Solution

As the first modular product of Transplants for Kids, PEDS LIVER SELECT will be a novel, flexible, and powerful tool offering decision support to clinicians on best pediatric liver transplant options. Our innovation constitutes a new software module for a commercially deployed product, that provides proprietary protocols for matching transplant candidates with optimal organ offer types nationally and makes them available on the transplant physician’s smartphone. In our first phase, we will validate optimal recipient and donor matching to eliminate waitlist mortality using center-specific and national transplant data and then combine this with the software infrastructure of OmniLife to ease implementation and dissemination in Phase 2 and 3.

The solution is a point-of-care solution that will be used to facilitate decision making for the clinician evaluating a donor offer for their patient. Our planned software tool will demonstrate expected survival outcomes of using a specific offered organ by providing up-to-date national outcomes accounting for center and recipient characteristics. This will transform the current highly manual process and augment it with data driven outcomes supporting use of a particular organ.

Competition

The competitive landscape analysis below summarizes key features of this solution, and current competitors working to solve similar healthcare problems.

Team

  • George Mazariegos, MD, Professor of Surgery and Critical Care Medicine, University of Pittsburgh; Chief of Pediatric Transplantation, UPMC Children’s Hospital of Pittsburgh. He is on faculty at the McGowan Institute for Regenerative Medicine.

  • Eric Pahl is the founder of OmniLife, a software development and analytics company serving the organ procurement and transplantation industry with mobile and real-time clinical communication and decision support tools.

  • Jim Squires, MD, Assistant Professor of Pediatrics, University of Pittsburgh. As a transplant hepatologist, Dr. Squires will help plan the recipient assessment utilized in the matching algorithm.

  • Kyle Soltys, MD, Associate Professor of Surgery, University of Pittsburgh. As a transplant surgeon, Dr. Soltys will help develop the donor assessment criteria and surgical split dissemination tools.

  • CJ Confair will coordinate Starzl Network project activities specific to Transplant for Kids and coordinate network dissemination.

  • Alex Kepler is the Research Coordinator at UPMC Children’s Hospital of Pittsburgh and will handle all regulatory documents related to the Project.

Milestones

  • Milestone 1: Using data from the United Network for Organ Sharing (UNOS) and a national registry (Society of Pediatric Liver Transplant [SPLIT]), we will develop a machine learning/artificial intelligence (AI) informed algorithm to establish protocols to assist clinicians in matching the available organ offer for their patient.

  • Milestone 2: Deliver model data into the existing OmniLife Platform to assist in decision support for organ offers in pediatric liver transplant and perform pilot trials at UPMC Children’s Hospital of Pittsburgh.

  • Milestone 3: Test user interface in Starzl Network sites to advise on final prototype.

Path to Impact Plan

The Starzl Network accounts for approximately 25% of the pediatric liver transplant volume annually in North America and will be the optimal test lab for implementation of the completed prototype. The Network is a consortium of 10 centers committed to eliminating pediatric waitlist mortality and improving outcomes for all children undergoing transplantation and performed over 1000 pediatric transplants in the past 10 years. To date, the Network has established a common data system, IRB, data use agreements, and shared project initiatives and priorities.

If awarded, Transplants for KIDS will be a project focus within the Network, enabling synergy in many processes and requiring minimal infrastructure development for successful execution. The use of this decision support will be tested by the team at UPMC, validated in the Starzl Network centers, and then deployed more widely. PEDS LIVER SELECT will be the first module within Transplant for KIDS. Application for adult liver transplantation such as extended donor criteria livers, donors after cardiac death, and split livers which are currently rarely used will be the first adult application of this project. Other organ-specific modules will be added subsequently expanding opportunities for grant and foundational funds beyond traditional pediatric liver transplant resources.

Frequently Asked Questions

Dissemination and sustainability will be a challenge.

Utilizing the Starzl Network will minimize barriers to dissemination and sustainability. The Network is focused on providing ‘the right care at the right time’ to every child across the spectrum of pediatric transplant practice, which aligns well with our proposal; centers have already committed to testing our product.

Are decision support tools really the best solution to the problem?

Transplant decisions are complex with >100 variables often considered in a single donor-recipient ‘‘best matching’’ scenario. The risk of subjectivity and mismatch because of human limitations should not be underestimated and decision support tools are emerging for their potential to support or validate decision making within the field.

How innovative is this if it’s just adding a pediatric specific module onto an existing platform for adult transplant?

Transplant for Kids expands the use of decision support in transplant beyond the traditional renal system, strengthening its foothold within transplant. More notably, demonstration of project success could have broader health economic and quality of life impacts as optimization of pediatric care extends outcomes for much longer periods than adults.

Are there enough patients and clinical users at each stage of testing?

CHP has single center experience with >1,200 transplants and the Starzl Network accounts for 25% of transplant volume among 10 centers to assure adequate users and patients at each stage.

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