Broad Pragmatic Studies Funding Announcement -- 2022 Standing PFA
PCORI is pleased to announce the simplification and expansion of two longstanding funding opportunities known as the Broad PCORI Funding Announcement (PFA) and Pragmatic Clinical Studies (PCS) PFA. Starting in Cycle 1 2022, PCORI combined these two PFAs into a single PFA entitled the Broad Pragmatic Studies (BPS) PFA. This new PFA covers the following four priority areas: Addressing Disparities; Assessment of Prevention, Diagnosis, and Treatment Options; Communication and Dissemination Research; and Improving Healthcare Systems. These broad areas encompass the patient-centered comparative clinical effectiveness research (CER) that PCORI has long funded.
PCORI will commit up to $162 million per cycle through this funding opportunity. The BPS PFA will offer two categories for award size, with targeted funding allotments for each, to promote a balance of smaller and larger studies within the funded portfolio. One study category will include studies with direct costs up to and including $5 million, consistent with the previous scope of studies under the Broad PFAs. The other will permit awards requesting direct costs greater than $5 million, up to a maximum of $10 million, consistent with the size of studies eligible for submission under the PCS PFA. Applications proposing direct costs between $5 million and $10 million total will be expected to justify the size and scope of the proposed research and how additional funds are necessary with respect to the scale, scope, and complexity of personnel and material resources needed to address the proposed research question. The combined PFA will allow submissions with both randomized and nonrandomized study designs.
For more information on how this change will optimize alignment of proposed studies with PCORI PFAs, please refer to the Leadership Perspective released in December 2021.
The Broad Pragmatic Studies PFA is intended to avoid confusion for potential applicants about which funding opportunity is most appropriate for their research proposal and assist applicants in their long-range research planning with the broader range of study size options under the two funding level categories noted above. Researchers who plan resubmissions to the PCS PFAs (Cycle 1 2021 and beyond) or the Broad PFAs will be eligible to apply to the combined BPS PFA.
The Broad Pragmatic Studies PFAs will extend two pilot PCORI initiatives. First, all applicants submitting to this PFA will be eligible to request coverage of patient care costs subject to meeting-specified criteria and negotiation/approval by PCORI. Likewise, all applicants to the BPS PFA will be able to defer application submissions for invited Letters of Intent for up to two subsequent funding cycles.
Increase in Maximum Direct Cost Cap for Communication and Dissemination Research Priority Area
Under the Communication and Dissemination Research priority area, PCORI invites applications that support approaches to comparing communication strategies, dissemination strategies, or implementation strategies for overcoming barriers to adoption, adaptation, and integration into routine clinical care, and sustainability of evidence-based interventions. Additionally, PCORI is interested in comparing strategies for stopping or halting practices that have not been proven to be effective and are possibly harmful, also known as de-implementation.
PCORI has increased the maximum direct cost project budget for proposed studies in this priority area to be up to $5 million for each award, with a maximum performance period of five years. Please note, proposed applications may not exceed $5 million in direct costs if germane to the Communication and Dissemination Research priority area.
Special Areas of Emphasis |
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PCORI has identified Special Areas of Emphasis (SAEs) for the Cycle 3 2022 Broad Pragmatic Studies PFA to support innovative, high-impact studies that fit clearly within our core mission of patient-engaged and patient-centered comparative clinical effectiveness research (CER). The purpose of calling out these SAEs is to encourage submissions to these areas, not to limit submissions to these topics. Applicants addressing an SAE must identify which priority area for research is best associated with their research approach. Addressing Racism, Discrimination, and Bias in Healthcare Systems and Care DeliveryPCORI is allotting up to $20 million to fund CER on multilevel, multicomponent strategies to address racism, discrimination, and bias in healthcare organizations and integrated care delivery systems. In this cycle, PCORI will focus on comparisons of multilevel, multicomponent health approaches addressing racism, discrimination, and bias based on race, ethnicity, and/or nativity (e.g., country of birth, immigration status). Subsequent funding cycles are anticipated to focus on discrimination and bias based on factors other than race, ethnicity, and/or nativity. PCORI invites applications in all clinical areas. PCORI is particularly interested in applications proposing strategies addressing racism, discrimination, and bias in healthcare delivery that contribute to disparities in pain control (e.g., the assessment, treatment, or management of acute or chronic pain) and cancer care (e.g., screening, treatment, and the health and wellbeing of cancer survivors). Applications assessing the comparative effectiveness of approaches including, but not limited to, the following are invited: interventions to address racism, bias, and/or discrimination in healthcare organization policy, practices, and processes; interventions to improve care, access to care, and care navigation; and approaches designed to address interpersonal bias for people working in healthcare settings. Outcomes of interest include relevant clinical, health, or health utilization outcomes (e.g., receipt of guideline-based curative or preventive treatment, time to referral to clinically appropriate level of care, or consult with an appropriate specialist); patient engagement, satisfaction, and experience with care; care continuity; organizational performance relevant to equity; and social determinants of health. Subsequent funding cycles are anticipated to focus on discrimination and bias based on factors other than race, ethnicity, and/or nativity. Caregiver-Delivered Interventions for Intellectual and Developmental DisabilitiesPCORI is allotting up to $20 million to fund CER on evidence-based and/or commonly used caregiver-delivered interventions spanning the continuum of care for those with intellectual and developmental disabilities (IDD). Proposed interventions can be single or multicomponent (i.e., “complex interventions”) and may target the person with IDD, or both the person with IDD and the caregiver. Comparisons of particular interest may include but are not limited to the following: comparison of caregiver-delivered interventions vs. those not delivered by caregivers or those delivered by both caregivers and trained professionals; comparison of different delivery modes dose, and/or duration; communication strategies that aim to improve shared decision making between caregivers, individuals with IDD, and providers as it relates to caregiver-delivered interventions; and dissemination or implementation strategies with demonstrated success in integrating and/or sustaining evidence-based caregiver-delivered interventions into practice. Outcomes of particular interest include any of the following but are not limited to: physical/mental health, social-communication, daily living, and independent living outcomes related to IDD; improved quality of life and/or reduced harms for the person with IDD and caregiver; and caregiver mental health, decreased stress and burden, improved intervention fidelity, and decreased time away from work/lost wages. Studies that prioritize diverse and underserved populations (e.g., racial and ethnic minority groups, low-income groups, residents of rural areas, those with limited English proficiency, etc.) are highly encouraged. Optimizing Prevention and Treatment of Postpartum HemorrhagePCORI is allotting up to $20 million to fund CER focused on the prevention and treatment of postpartum hemorrhage (PPH) in delivering women. Timely recognition of blood loss and clarity regarding the optimal choice of pharmacologic agents and other interventions targeted at the treatment of PPH have been identified as key areas for improving these outcomes. Applications assessing the comparative clinical effectiveness of approaches, include but are not limited to the following are of interest: protocol-driven workflow processes; uterotonics and other pharmacologic agents; and active management, including surgical interventions. Outcomes of interest include the incidence of PPH within 24 hours postpartum, total blood volume loss within 24 hours postpartum, maternal morbidity, maternal mortality, adherence to PPH care protocols, and quality of care. Given disparities in PPH incidence, outcomes, and overall maternal morbidity and mortality, studies that target racially/ethnically diverse populations that experience disparities in postpartum hemorrhage outcomes are of particular interest. Visual Impairment in Older AdultsPCORI invites applications for CER of interventions to improve screening and early detection, treatment, or vision rehabilitation for eye conditions that lead to vision loss and visual impairments in older adults (e.g., age-related macular degeneration, diabetic retinopathy, and primary open-angle glaucoma). Interventions of interest include but are not limited to: novel approaches to screening trials that target higher-risk populations and address barriers to screening, Strategies for promoting adherence and improving linkages to follow-up care for older adults who screen positive, treatment and rehabilitation recommendations, and telehealth. PCORI is particularly interested in patient-reported outcomes, such as vision-related quality of life, vision-related functional impairments on activities of daily living (e.g., reading, grooming, driving, preparing meals), mental health symptoms, and physical functioning (e.g., mobility, falls, other injuries), psychosocial functioning, and cognitive functioning. Other outcomes of interest include, but are not limited to, visual acuity, visual field, disease progression as measured by a standardized classification system (e.g., Diabetic Retinopathy Severity Score), or other disease-specific clinical features. |
Key Dates
Cycle 1: July 2022
Cycle 1: November 15, 2022
Cycle 1: March 2023
Funds and Project Period
Category 2: $90 million across all priority areas
Note: Through this funding opportunity, PCORI intends to commit up to $162 million.
-- Less than or equal to $5 million direct costs
Category 2: Addressing Disparities; Assessment of Prevention, Diagnosis, and Treatment Options; Improving Healthcare Systems:
-- Greater than $5 million; up to $10 million direct costs
Note: (Special Areas of Emphasis (SAEs) are permitted to apply to either category
Tags
- 2022 Standing PFA