Cardiovascular Health Topical PFA FAQs

Cardiovascular Health Topical PFA Questions

Does my research proposal have to address one of the Special Areas of Emphasis (SAEs)?

No; SAEs aim to encourage applications on a particular topic—not to restrict applications to only the SAEs.

There are several SAEs listed as options on the LOI submission page under question “which SAE does your study address”. Which one do I select?

All of PCORI’s research SAEs across different PFAs are listed under this question. For the Cardiovascular Health PFA, please select only the SAEs pertinent for Cardiovascular, which are:

• C3 Cardiovascular: PAD
• C3 Cardiovascular: Transitions in Care/Coordination
• C3 Cardiovascular: Increased use of Guideline-Directed Care

Will this funding opportunity accept proposals aiming to develop new mobile applications, online platforms, survey instruments, etc.?

No. Projects aiming to develop new interventions that lack established evidence of efficacy or effectiveness or widespread use, such as instrument development; app development; developing, testing, and validating new decision aids and tools; or clinical prognostication tools, will be considered out of scope. The comparison of evidence-based and/or widely used mobile applications or instruments may be responsive if applicants sufficiently justify the selection of comparators. For example, cultural tailoring or other adaptation of an existing efficacious or widely used intervention is permitted, if it seems likely to succeed in a specific underserved or understudied population for which efficacy data may not exist.

Does this PCORI Funding Announcement (PFA) primarily seek applications addressing cardiovascular disease, e.g., coronary artery disease?

While coronary artery disease is certainly relevant to this PFA, it is not the only focus. This PFA seeks to fund high-quality comparative clinical effectiveness research (CER) studies that address cardiovascular disease prevention, screening, diagnosis, treatment or posttreatment recovery, or that focus on interventions and care-delivery strategies that improve cardiovascular health outcomes in populations experiencing disparities. This funding announcement uses a broad definition of cardiovascular disease to include diseases or conditions of the heart or vascular system, and risk factors; and diseases or conditions associated with a high risk for the development of cardiovascular disease, such as diabetes or chronic kidney disease.

Are there any cardiovascular topics that are not responsive to this funding announcement?

Studies that focus exclusively on health system interventions to improve the control of hypertension alone will not be considered responsive unless part of a larger strategy that includes improvement in control of other risk factors on the outcome of reduced cardiovascular disease risk.

Studies that seek to answer questions within the National Priorities of Health Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research will be considered non-responsive to this announcement. Studies with an intervention arm that solely involves introduction of a Community Health Worker (CHW) or patient navigator will be considered non-responsive; however, studies where CHW or patient navigation is embedded in research questions may be responsive.

For research comparing the effectiveness of devices, must the device currently be commercially available and widely used, or is Food and Drug Administration (FDA) clearance sufficient for inclusion?

Yes. FDA clearance for the purpose being studied is sufficient.

Can one comparative-treatment option be a new option for patients? For example, enhanced care based on literature but not currently in routine practice?

If the new option has previously been demonstrated to be efficacious or effective in one or more controlled trials and is likely to become commonly available, then it is legitimate to compare its real-world effectiveness to that of other available options.

Budget

Can I exceed the direct cost maximum for the Topical Cardiovascular Health PFA? 

The standard direct cost maximum for this Cardiovascular Health PFA is $12 million. If permission is granted by PCORI at the LOI stage, before application submission, investigators may request larger budgets with certain justifications.  

Any such justifications must relate to activities that substantively enhance the CER aims and are relevant to this PCORI PFA. Examples of these activities could include increasing the potential value of the knowledge to be gained, ensuring feasibility of achieving study aims, or enhancing the sample size to allow precision in the estimation of the hypothesized effect sizes and conduct of planned heterogeneity of treatment effect analyses. Cost sharing is highly encouraged. 

Investigators must, in their LOIs, indicate the intent to exceed the $12 million maximum. PCORI’s approval or disapproval of the intended budget request will be communicated in the decision provided on the LOI Status Notification Date. Project budgets that exceed the $12 million direct cost maximum without prior PCORI approval will be administratively withdrawn and not forwarded for further review. 

For this PFA, investigators should request to speak with a Program Officer prior to submission of the LOI for all requests to exceed the direct cost cap of $12 million. 

Patient Care Costs

What patient care (or intervention) costs may be proposed for PCORI funding support?

Applicants may propose unmet costs for study procedures, treatments, interventions, intervention devices, or clinical care (patient care) which are collectively termed “patient care costs.” Patient care costs include the intervention being studied as well as clinical personnel costs associated with administering the intervention. The cost of drugs and personnel needed to administer drugs may be proposed as patient care costs.

PCORI encourages applicants to maximize patient care cost coverage from all available outside sources before requesting PCORI coverage of unmet needs. Sources of coverage may include the host healthcare delivery system, third-party payer, product manufacturer, developer of the intervention or other interested parties.

When do I need to notify PCORI of the intention to request patient care costs for my proposed study?

We ask that investigators schedule a call with PCORI by submitting a request using [email protected] to discuss the request for patient care costs prior to submitting the LOI. Investigators should describe all patient care costs and the total amount requested within the LOI.

Are costs associated with the distribution (as opposed to the administration) of drugs and intervention devices and pharmacy cards considered patient care costs?

No, the infrastructure and resources (including personnel) needed to distribute (as opposed to administer) drugs and intervention devices as well as pharmacy cards are considered research costs and not patient care costs.

Are costs associated with telehealth delivery of non-pharmacologic interventions (e.g., cognitive behavioral therapy) considered a patient care cost?

Yes, costs associated with non-pharmacologic interventions such as behavioral therapies would be considered eligible interventions under the patient care cost allowance.

Are the costs for devices (e.g., tablets and internet hotspots needed for telehealth delivery of behavioral therapies) considered a patient care cost?

Yes, the costs for devices and resources such as internet hotspots necessary for accessing a telehealth intervention would be considered a patient care cost. The devices must be used exclusively for the PCORI project, and the need must be well-justified.

Is there a maximum budget for requested patient care costs? 

Patient care costs must be within the $12 million direct costs maximum unless given approval by PCORI to exceed the $12 million direct costs maximum.  

What is an example of evidence that would support the patient care costs criteria of sustained uptake of study results?  

Letters of support from payers or health care systems committing to future support of the proposed patient care costs—pending the results of the study—would provide evidence of stakeholder support and an increased likelihood for future sustainability and uptake of results.

National Priorities and Topic Themes FAQ

Should my study align with PCORI’s National Priority Areas for Health? 

This funding opportunity seeks applications addressing four of PCORI’s National Priorities for Health. To be considered responsive, applications must propose research meeting the distinctive requirements of this PFA addressing at least one of the following National Priorities for Health: 

• Increase Evidence for Existing Interventions and Emerging Innovations in Health
  • Goal: Strengthen and expand ongoing comparative clinical effectiveness research focused on both existing interventions and emerging innovations to improve healthcare practice, health outcomes and health equity.
• Accelerate Progress Toward an Integrated Learning Health System
  • Goal: Foster actionable, timely, place-based and transformative improvements in patient-centered experiences, care provision and ultimately improved health outcomes through collaborative, multisectoral research to support a health system that understands and serves the needs and preferences of individuals.
• Achieve Health Equity
  • Goal: Expand stakeholder engagement, research and dissemination approaches that lead to continued progress toward achieving health equity in the United States.
• Advance the Science of Dissemination, Implementation, and Health Communication
  • Goal: Advance the scientific evidence for and the practice of dissemination, implementation and health communication to accelerate the effective sharing of comparative clinical effectiveness research results for public understanding and uptake into practice.

Applicants will be asked to select one of the four National Priorities above as primary, and if relevant, a secondary and/or tertiary National Priority in their LOIs and, if invited, full application.

How do I determine to which National Priority for Health my research best aligns? 

The primary aim or research question will typically guide the designation of the application’s primary National Priority for Health. Applications are allowed to optimize and synergize multiple priorities in their proposed research. If multiple priorities are addressed in an application, applicants should designate their relative priority for PCORI to use in guiding LOI and application review. 

What is the difference between PCORI’s National Priorities Areas for Health, and the 12 topic themes identified within the Cardiovascular Health PFA?

The Cardiovascular Health Topical PFA seeks applications that address four of PCORI’s five National Priorities for Health. To be considered responsive, applications must describe research that compares at least two alternative approaches to achieve one or more of the National Priorities for Health. Applicants will be asked to select a primary National Priority, and, if relevant, a secondary and/or tertiary National Priority in their LOIs, and if invited, in their full application.

PCORI has a total of 12 topic themes of interest that will inform PCORI’s funding opportunities over the next several cycles.  Improving cardiovascular health is one of the 12 topic themes, and consideration of other themes is welcome but not required.  Within Letters of Intent and Applications, applicants will be asked to designate the primary, and as applicable, secondary and/or tertiary topic theme(s) with which their proposed research most closely aligns.

At the LOI stage, PCORI suggests selecting “Improving cardiovascular health” as the primary topic theme.   Applicants may also select “other” if their research does not align with any listed theme. Additional information about the topic themes and example projects is available on the PCORI website.

As mentioned above, submissions are not limited to these topic themes; however, all Cardiovascular Health applications must select one of the four PCORI National Priorities for Health identified in the PFA.

General Questions

I have several questions/would like to speak with a Program Officer about my proposal. What is the best mechanism to use?

For the Cardiovascular Health PFA, we ask that investigators submit questions and requests for a call using [email protected]. A call to discuss patient care cost coverage is recommended, and a call is required for requests to exceed the direct cost cap of $12 million. Investigators should describe all patient care costs and the total amount requested within the Letter of Intent (LOI).

How many LOIs am I permitted to submit to this PFA in this cycle?

Applicants may submit multiple LOIs within the same PFA or across multiple PFAs provided the proposed LOIs do not exhibit significant scientific overlap. Moreover, an individual listed as a principal investigator (PI) on one LOI may be listed as and serve in another role (e.g., co-investigator or consultant) on other LOIs within the same PFA during the same cycle. If a PI submits multiple LOIs under this or other PFAs offered within a given cycle, LOIs that exhibit scientific overlap or that appear to be duplicate submissions will be disqualified. PCORI will contact the PI to choose which LOI should advance to review. The restriction on overlapping or duplicate submissions applies to single- and dual-PI submissions.

I have been invited to submit a full application based on my accepted LOI. Am I allowed to make any changes from the approved LOI to be reflected in my full application?

You are invited to submit an application based on the information provided in the LOI. Any changes to the following require PCORI’s approval:

• PI (Contact PI and Dual-PI, if applicable)
• Institution
• Study design
• Research question(s)
• Primary outcome measure(s)
• Specific aims
• Comparators

If you need to change any of this information or have any questions, email [email protected].

What Is PCORI’s Policy for Data Management and Data Sharing and how does it apply to this PFA?

Fundamentally, the Policy articulates PCORI’s expectation that awardees make the data from their PCORI-funded research projects available to third-party requestors. Importantly, it provides funding to our awardees for their time and effort in preparing the data to be shared. The Policy includes details about what data certain awardees will be expected to deposit into a designated data repository and when that data would be available for third-party requests. It describes the data request process, the criteria used to assess the scientific merit of the requests and the independent committee that will review data requests. Please refer to the Policy webpage, data sharing FAQs and the full PFA for more information on PCORI’s Policy for Data Management and Data Sharing.

Posted: September 1, 2023