Broad Pragmatic Studies Funding Announcement -- 2024 Standing PFA (Cycle 1 2024)

Notice of Upcoming PCORI Funding Announcement

The Patient-Centered Outcomes Research Institute (PCORI) intends to release a Broad Pragmatic Studies (BPS) PCORI Funding Announcement (PFA) on January 9, 2024, which seeks to fund applications for high-quality patient-centered comparative clinical effectiveness research (CER) projects.

All applications must align the proposed research with at least one of the four National Priorities for Health described within the PFA. Topic Themes are also included in this funding opportunity. Applicants have the option to choose up to three Topic Themes based on how their proposed research aligns with the themes. However, aligning with any Topic Theme is not required. The National Priorities for Health and Topic Themes will assist PCORI in determining the optimal review pathway for the proposed research.

National Priorities for Health

PCORI’s National Priorities for Health are a comprehensive set of mutually reinforcing goals that focus on impact, guiding PCORI research funding and other initiatives to improve patient care and health outcomes. The breadth of the goals allows for flexibility, agility, and responsiveness to foreseen and unforeseen changes in the healthcare landscape. The National Priorities for Health were developed, revised and finalized with extensive stakeholder input.

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The National Priorities for Health build on PCORI’s longstanding funding framework of research approaches to improve patient-centered health through CER. Applicants should be able to recognize how their proposed CER may serve and align with one or more National Priorities for Health. For example, research to help Achieve Health Equity may compare existing and emerging evidence-based innovations in health system delivery, making use of alternative health communication methods to increase access to care for historically underserved and under-researched populations. This example illustrates how a research study can have multiple connections to PCORI’s National Priorities for Health.

Topic Themes

PCORI has currently 12 Topic Themes of interest that inform PCORI’s funding opportunities over the next several cycles.  PCORI’s Topic Themes speak to everyday health issues facing large numbers of people in the United States including children, youth and older adults and address urgent topics such as substance use, mental and behavioral health, and violence and trauma, as well as widespread conditions including cardiovascular disease, pain management and sleep health. These themes include four key topics that have been important interest areas for PCORI—preventing maternal morbidity and mortality, improving outcomes for people with intellectual and developmental disabilities (IDD), addressing COVID-19, and addressing rare disease.

Applicants to the Cycle 1 2024 BPS PFA may select up to three of PCORI’s 12 Topic Themes that best align with their proposed research. Applicants may also opt not to select from the PCORI Topic Themes and select “other” to indicate that their research aligns with other areas of important need for patient-centered CER. In keeping with past cycles, the BPS PFA welcomes all investigator-initiated, patient-centered CER.

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Special Areas of Emphasis

PCORI has identified Special Areas of Emphasis (SAEs) within this BPS funding opportunity to support innovative, high-impact studies that fit clearly within our core mission of patient-engaged and patient-centered CER.

The purpose of calling out these SAEs is to encourage submissions to these areas, not to limit submissions to these areas. Applicants addressing an SAE must identify which priority area for research is best associated with their research approach.

• Long COVID: PCORI is interested in supporting research to test the comparative effectiveness of clinical interventions and health system strategies addressing the impact of Long COVID on health and patient-oriented outcomes. Studies focused on models of care designed to improve management of Long COVID are especially encouraged.
• Social Needs/Social Determinants of Health: Social needs and the corresponding social determinants of health reflect underlying contributors to health inequities. PCORI is interested in supporting high-quality comparative clinical effectiveness research projects testing the impact of interventions that address social needs on patient-centered outcomes. Of particular interest are interventions that have been shown to be efficacious or are in widespread use to address social needs in at least one of the following domains: food insecurity, food as medicine, transportation and housing security/stability.
• Post-Traumatic Stress Disorder: PCORI is interested in supporting research to test the comparative clinical effectiveness of treatment options for post-traumatic stress disorder (PTSD). Of particular interest are studies including children and youth, veterans, and civilian adults with varying types of trauma. Studies focused on comparing strategies to enhance delivery of PTSD care outside of specialty mental health settings and advancing health equity are especially encouraged.

Broad Pragmatic Studies PFA: Category 1, Category 2 and Category 3 Study Specifications

PCORI will commit up to $160 million per cycle through this funding opportunity. The BPS PFA will offer three categories based on award size and requirements. All applications, regardless of category, must align the proposed research with at least one of the four National Priorities for Health described within the PFA.

Category 1

• Category 1 will support research projects with direct costs up to and including $5 million.

Category 2

• Category 2 will support research projects with direct costs greater than $5 million and up to a maximum of $10 million. Applications for funding under Category 2 will be expected to justify the proposed research's size and scope and why additional funds are necessary to support the scale, scope, and complexity of personnel and material resources needed to address the research question.

Category 3

• Category 3 will support research projects with direct costs up to $10 million that utilize PCORnet^® to conduct observational studies and/or pragmatic trials that are national in scale. Category 3 PCORnet Studies^® must include two or more Clinical Research Networks and share study progress, performance metrics and best practices with the network to promote continuous learning and improvement. PCORnet Studies will leverage the PCORnet Common Data Model® as appropriate. Additional details about Category 3 can be found on the PCORI website.

For Category 2 and Category 3, projects may request to exceed the direct cost maximum of $10 million and apply for up to $12 million in direct costs with certain justifications described within the PFA and with PCORI approval conferred at the Letter of Intent (LOI) stage prior to application submission.

Pilot Initiatives: Coverage of Patient Care Costs and Deferrals

The BPS PFA will continue to offer two pilot PCORI initiatives.

First, all applicants submitting to this PFA may request coverage of patient care costs. Coverage of these costs will be subject to meeting specified criteria that PCORI will use to determine which costs, if any, may be acceptable for potential funding. PCORI funding for requested patient care costs is not assured.

Second, all applicants to the BPS PFA will be able to defer application submissions for invited LOIs for up to two subsequent funding cycles. Researchers who previously elected to defer their PCORI applications from the Cycle 2 2023 and Cycle 3 2023 BPS PFAs will be considered eligible to submit to the Cycle 1 2024 BPS PFA.

Standing 2024 BPS PFA

Continuing the practice started with Cycle 1 2022, PCORI posts all submission materials for the BPS PFA and opens PCORI Online for the LOI phase of application submission at the start of the funding cycle year (i.e., cycles 1–3 of any given year). In addition to the PFA, the Submission Instructions, applicant templates and resources, and cycle deadlines will also be posted on PCORI’s website and available in PCORI Online. Applicants may submit an LOI for any available cycles until the LOI deadline for that cycle. PCORI will strive to make only necessary administrative updates to the Submission Instructions and applicant templates throughout the cycle year.

To maintain responsiveness to health research needs and patient and stakeholder interests, PCORI may revise the BPS PFA details, address policy changes, and add or remove a theme or SAE. Topic Themes and SAEs aim to encourage applications on a particular health topic, not restrict applications to only the themes or SAEs.

Announcements of any updates and any revised documents will be posted on PCORI’s website no later than four weeks before each cycle’s LOI deadline.

This preannouncement is provided to allow potential applicants additional time to identify collaborators; obtain patient and stakeholder input on potential studies; and develop responsive, high-quality proposals. For questions regarding this funding announcement, please reach out to [email protected].