Cardiovascular Health Topical PCORI Funding Announcement -- Cycle 3 2023

This Topical PCORI Funding Announcement (PFA) invites applications for comparative clinical effectiveness research (CER) on key decisional dilemmas in the fields of cardiovascular disease prevention (CVD), screening, diagnosis, treatment, and posttreatment recovery and studies that focus on interventions and care delivery strategies that improve cardiovascular health outcomes in populations experiencing disparities.  

Research Initiative Highlights  

Cardiovascular disease is the leading cause of death in the United States, accounting for one in every five deaths. Despite tremendous advances in diagnostic strategies and treatment options, there are still many unanswered questions in this field and many populations have suboptimal outcomes. Women and people from underserved populations continue to have a higher prevalence of risk factors for cardiovascular disease and worse cardiovascular outcomes. PCORI is interested in funding studies that will advance the field of cardiovascular disease prevention, screening, diagnosis, treatment, and posttreatment recovery and improve patient-centered outcomes.   

This funding announcement uses a broad definition of cardiovascular disease. Studies focused on diseases or conditions of the heart or vascular system or on risk factors associated with the development of cardiovascular disease will be considered eligible. Studies that focus exclusively on the control of hypertension through health system interventions alone will be considered nonresponsive unless part of a broader strategy to reduce cardiovascular disease risk.   

While the funding announcement is open to many comparative clinical effectiveness research questions, the following Special Areas of Emphasis (SAEs) are of particular interest to PCORI: 

• Peripheral Arterial Disease (PAD): PCORI is interested in supporting research in therapeutic options for patients with either intermittent claudication and/or critical limb ischemia. Studies focused on reducing disparities in care are especially encouraged.  

• Transitions in Care/Care Coordination: Transitions in care settings (such as hospital to rehabilitation facility to home) or healthcare experience (such as after pregnancy) and lack of coordination between clinicians (such as between an oncologist and cardiologist) can result in missed prevention and treatment opportunities resulting in poor cardiovascular outcomes. PCORI is interested in studies testing strategies to improve these transitions and improve health outcomes.   

• Increased Use of Guideline-Directed Care: Women and underserved individuals have worse cardiovascular outcomes and are less likely to receive guideline-directed care for prevention, screening, diagnosis and treatment of cardiovascular disease and its risk factors. Barriers have been observed in both clinician and patient initiation and continuation of guideline-directed care in these populations. PCORI is interested in studies testing approaches to equitably implement guideline-directed care, especially for populations experiencing disparities in outcomes.

The purpose of identifying these SAEs is to encourage submissions to these areas, not to limit submissions to these topics. Applicants addressing a SAE should identify the area that is best associated with their research approach. 

Applicants are strongly encouraged to propose individual, or cluster randomized, controlled trials; however, well-specified natural experiments and well-designed observational studies will also be considered. Proposed studies should examine large and diverse populations with an overall sample size that will allow precision in the estimation of hypothesized effect sizes and, as appropriate, analysis of heterogeneity of treatment effect. Applicants are encouraged to pay special attention to issues of intervention implementation with an aim of facilitating widespread uptake of findings after completion of the study. However, strict implementation or dissemination studies will be considered non-responsive as will studies focused on the development of research methods. Applicants should propose well-justified cardiovascular-related outcomes that are clinically meaningful and considered important by patients and that can be impacted by the proposed intervention within the study duration. 

Applicants should consider, as appropriate, the full range of cardiovascular health-related clinical and patient-centered outcomes data relevant to patients and other stakeholders. PCORI’s Principles for the Consideration of the Full Range of Outcomes Data in PCORI-Funded Research inform the expectations for applicants and the corresponding evaluation of applications submitted in response to this PFA.  

This funding announcement will accept applications with direct costs up to $12 million dollars and up to five years in duration. For this funding announcement, applicants may request coverage of patient care costs (including medical products, procedures and care services) for potential funding by PCORI. These costs are included as part of the overall direct costs. PCORI may consider applications that exceed the stated direct cost cap. Applicants must discuss such a request with PCORI to seek permission to exceed the direct cost cap prior to submission of a Letter of Intent.  Please contact PCORI ([email protected]) to schedule a consultation. 

PCORI encourages all investigators interested in applying to request a conversation with a PCORI Program Officer via [email protected] prior to submitting a Letter of Intent.