LOIs and applications will be considered nonresponsive to this PFA and may be administratively withdrawn if the project proposes to do any of the following:
- Establish efficacy or effectiveness of SDM strategies, or to study the comparative clinical effectiveness of multiple SDM strategies
- Applicants interested in conducting CER should consider applying to PCORI’s Communication and Dissemination Research Program using the appropriate application materials. Projects proposing the performance of CER under this PFA will not be referred and will be withdrawn as nonresponsive.
- Implement evidence that does not include a PCORI-funded CER or methods study result
- Translate or adapt an SDM approach without actively implementing it
- Develop or validate a new tool or system for patients or clinicians without the primary purpose of actively implementing evidence
- Modification or adaptation of tools and systems previously found to be effective and proposed as the primary mechanism for actively disseminating and implementing evidence will be considered, as long as their development is not the primary activity proposed
- Use contract funds to incentivize or compensate sites, site personnel, or patients for completing training and/or participating in proposed implementation activities.
- In general, PCORI does not pay the cost of the interventions being implemented in the projects it funds. Intervention costs include, but are not limited to, activities to identify, recruit, or enroll patients to receive the intervention, salary, and time compensation for personnel who are delivering the intervention, as well as equipment and other material costs associated with delivering the intervention. These are considered patient care costs, and PCORI expects these costs to be covered by the healthcare delivery system or other interested payers. PCORI encourages all applicants to find support from sites, payers, stakeholders, and so on, in the payment or cost-sharing of the interventions. Only under special circumstances will PCORI consider, as an exception, coverage of patient care intervention cost.
If requesting the use of PCORI funds for any portion of these costs, the applicant must clearly describe these in the LOI. If approved to include these costs in a full invited application, the applicant must include a detailed justification in the Budget Justification Template outlining the importance of the request to the project’s overall success. The justification must also explain how costs will be covered in the future—post-PCORI funding—not only in the sites participating in the proposed project but also in other communities and healthcare settings that undertake the proposed strategies. Such a justification, however, will not guarantee that PCORI will approve the costs. Applicants should develop contingency plans in the event that PCORI does not approve the request.