Notice to Engagement Awardees: Please click here to access the Engagement Enhancement Funding Opportunity.
Notice to D&I Awardees: Please click here to access the D&I Enhancement Funding Opportunity.

Introduction

Severe Acute Respiratory Syndrome Coronavirus 2, otherwise known as COVID-19, is a novel respiratory illness that causes complications that can compromise lung function and lead to severe illness or death. COVID-19 imposes significant burdens for patients and their families and has led to acute disruptions in the US healthcare system due to its high incidence, low testing rates, challenging management options, and unknown long-term health implications. As of April 10, 2020, there were more than 427,000 confirmed cases and 14,696 deaths in the United Statesi and as many as 1.6 million cases worldwideⁱⁱ. Emerging reports of racial and ethnic disparities in the US death tollⁱⁱⁱ increase the complexity in developing a patient-centered response to address the pandemic.

Rooted in our mission to help people make informed healthcare decisions and improve healthcare delivery and outcomes, PCORI is poised to support work to provide answers to the challenging COVID-19 related dilemmas facing patients, caregivers, providers, health systems, and policymakers through targeted investments in extending our Research, Engagement Awards, and Dissemination and Implementation activities.

PCORI seeks investigator-initiated proposals to address the COVID-19 public health crisis through enhancements of currently funded PCORI research awards. Only PCORI-funded principal investigators with active research project funding contracts are eligible to submit a proposal in response to this announcement.

Please Note: We understand that many current research awards will require adjustments to enable the projects to proceed and to produce meaningful findings. While this announcement is not intended to solicit requests for modifications intended primarily to enable achievement of original, planned aims, we are committed to facilitating these types of modifications and suggest that awardees consult PCORI’s COVID-19 FAQs for guidance and for contact information to address these types of modifications and any related questions.

Purpose

PCORI has a strong interest in generating timely findings to provide answers to dilemmas facing patients, clinicians, health systems, and other stakeholders and entities battling the novel coronavirus pandemic in the United States. Through this funding announcement, we are interested in supporting enhancements to existing research awards that can be initiated quickly to influence the outcome of the current pandemic and that have some relationship to the original award, using existing teams that are currently funded by PCORI.

Enhancements may include: modest additions to existing aims (such as additional outcomes to be collected as they relate to COVID-19), or an adjunct project that has some relationship to the original award, including a new aim (or aims) designed to produce useful knowledge related to COVID-19 and the original award. Simultaneous adaptation of original aims to account for COVID-19 may also be proposed. Taking advantage of natural experiments in health system, state, and provider responses is strongly encouraged.

Scope

Enhancement proposals should adhere to the following:

• Addresses a current important issue facing the COVID-19 crisis (e.g., prevention, diagnosis, treatment, supply of critical resources, and health system adaptations including telemedicine, community outreach especially to vulnerable populations). Projects should propose to collect actionable outcomes specifically related to COVID-19.
• Has a relationship to the original research
• The research question related to COVID-19 should be framed utilizing a comparative effectiveness framework, or be expected to inform or lead directly to patient-centered comparative effectiveness research
• For current Methods awardees: Methodological research that enhances the rigor of collecting and analyzing data for studying pandemics and producing immediately applicable tools (e.g., predictive models) will also be considered.
• Primary outcome assessments collected within 2 to 12 months of study initiation
• Appropriate patient and stakeholder engagement to help refine the question(s), the study conduct, and dissemination of actionable results.

Enhancements to PCORI-funded PCORnet^® research infrastructure projects will be handled separately.

Specifications

Enhancements for all projects should seek to leverage existing project personnel expertise and infrastructure when possible. Additional personnel may be allowable if existing study personnel are unavailable or lack the requisite expertise for the Enhancement proposed. Though not required, evidence that existing project stakeholders support the proposed Enhancement is desirable.

While expedient generation of results is desirable for research projects, proposed Enhancements to these awards must adhere to the PCORI Methodology Standards. Note that Enhancement components that result in findings that are scheduled to finish significantly before the original full research project may be required to undergo separate and early Peer Review of the Enhancement component of the full research project.

Review and Approval Process

Enhancement proposals will be considered on a rolling basis. Following receipt of awardee-initiated proposals, PCORI will complete review of proposals. You may be contacted by your assigned Program Officer for additional information as part of PCORI’s review.

For research awards, determinations will be made using the criteria below:

• Past performance on current PCORI-funded project
• Added value to the field of COVID-19 research (i.e., is not redundant with existing studies or completed research)
• Relationship to original project
• Feasibility of rapid incorporation into the ongoing study
• Methodological rigor
• Budget is reasonable in the context of the other expenses for this project and general reasonable cost designations.

Proposal, Budget Summary, and Budget Justification Deadline

Proposals will be considered on a rolling basis, expected to be every two weeks, until Enhancements relating to COVID-19 are no longer warranted.