The Laura and John Arnold Foundation (LJAF), the American Society of Transplant Surgeons (ASTS), and the American Society of Transplantation (AST) are seeking to improve the health of patients who are waiting to receive an organ by increasing the number of transplants that occur each year. We are soliciting research proposals for developing and testing new transplant center performance metrics that are intended to reduce undue risk aversion among centers, incentivize innovation, and protect patient safety.
The demand for organ transplants is increasing as the population of the United States ages and more patients are diagnosed with chronic diseases that can lead to organ failure. But while there have been rapid advances in other areas of health care, the annual number of transplants has remained stagnant for years. As a result, the waiting list for organs has continued to grow—leading to lower survival rates, longer wait times, and higher health care costs.
One possible reason transplant rates have not risen is that transplant centers may discard organs unnecessarily. Federal performance metrics discourage centers from trying innovative interventions or using organs that may improve a patient’s health or chances of survival—but are not guaranteed to do so. Under the current system, transplant centers are heavily penalized, and might even be shut down, if a transplanted organ fails to meet a center’s designated outcome threshold. Experts have argued that this undue risk aversion exacerbates the shortage of organs and impedes advances in patient care.
In an effort to address this issue, we are seeking to identify evidence-based, data-driven alternative or supplemental transplant center metrics that result in a measurable increase in the number of organ transplants without compromising patient safety or quality of care. The most competitive proposals will test new metrics through retrospective data analysis and the design of a prospective pilot evaluation. To the extent feasible, the pilot evaluation should use a randomized controlled trial design.
Proposed projects must include the following:
- Evaluate the current evidence on Centers for Medicare & Medicaid (CMS) Conditions of Participation transplant center metrics in order to determine how the current set of metrics can be improved and to identify the criteria for an improved set of metrics.
- Develop a new set of transplant center metrics that enhances, complements, or replaces the current set of metrics.
- To the extent possible, run a retrospective analysis using the proposed alternative metrics against historical data to determine how transplant centers would have performed under the alternative scenario.
- Assess the implementation feasibility of the new metrics in terms of technology, regulatory, and other barriers to adoption.
- Conduct interviews with key stakeholders to determine any and all possible unintended consequences of the new metrics.
- Design a proposed pilot study to evaluate the effectiveness of the new metrics compared with existing metrics to determine potential real-world impact based on a pre-determined set of primary outcomes.
Academic, government, and industry-based investigators are invited to submit proposals. Applicants are not required to be members of ASTS or AST. The funding amount will vary based on the type and scope of the research proposed. The term of the funding will be one year, and only direct expenses will be covered by the research grant. The proposal should be no longer than five pages and should include the following:
- Name, title, and institution of principal investigator, co-investigator, and/or key collaborator(s)
- Description of the proposed research
- Budget, timeline, and milestones
- References to relevant prior published work
- Preliminary data collected
Deliverables at the end of the one-year research term should include (but are not limited to) the following:
- Manuscript of research paper outlining findings submitted to academic journals
- Executive summary policy brief
- Detailed proposal for CMS pilot program to test and evaluate the proposed new metrics, including:
- Description of pilot design and study methodology
- Pilot participants (to the extent possible)
- Budget, timeline, and milestones
Funding decisions will be made by an expert review committee that will include members of LJAF, ASTS, and AST. Grants will be scored and awarded on the basis of novel ideas, research approach, feasibility of obtaining relevant data, and prior work, as well as other factors.
Responses are due by May 1, 2016, and applicants will be notified regarding the status of their application by May 27, 2016. Grant awards will be officially announced during the 2016 American Transplant Congress (June 11-15, 2016). For teams that are selected, the term of the grant will begin in July. Please direct all proposal submissions and any questions concerning this RFP to TransplantRFP@arnoldfoundation.org.