The Broad PCORI Funding Announcements (PFAs) seek investigator-initiated applications for patient-centered comparative clinical effectiveness research (CER) projects aligned with our priority areas for research. This PFA covers the following four priority areas outlined in PCORI’s National Priorities for Research and Research Agenda: 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 CER we support.

Applications should address needs of patients, caregivers, clinicians, and other healthcare stakeholders in making personalized clinical decisions across a wide range of conditions, populations, and treatments. PCORI’s original authorizing law was amended by reauthorization legislation in 2019 to include expanded authority to consider, as appropriate, the full range of clinical and patient-centered outcomes data relevant to patients and stakeholders. The reauthorizing language clarifies that in addition to the relevant health outcomes and clinical effectiveness, relevant outcomes included within PCORI-funded projects may include the potential cost burdens and economic impacts of the utilization of medical treatments, items, and services when relevant to patients and caregivers or to other stakeholders. Please note that in general, PCORI will not cover costs for interventions that are being compared in the proposed study. There are no changes to the maximum project budget (direct costs) and maximum research project period from previous cycles.

Communication and Dissemination Research (CDR)

The goal of the CDR priority area is to support approaches to comparing communication strategies, dissemination strategies, or implementation strategies for overcoming barriers to adoption, adaptation, integration into routine clinical care, and sustainability of evidence-based interventions. Of additional interest is the comparison of strategies for stopping or halting practices that have not proved to be effective, and/or proven to be possibly harmful (also known as de-implementation). Research institutions or consortiums of institutions with expertise in communication, dissemination, and implementation research are encouraged to submit Letters of Intent in response to this PFA.

Special Areas of Emphasis

PCORI included three Special Areas of Emphasis (SAEs) in the Cycle 1 2021 Broad PFA. The goal of calling out these SAEs is to encourage submissions to these priority areas, not to limit submissions to these topics only.

As part of PCORI’s reauthorization in December of 2019, Congress included two new national priority areas: maternal morbidity and mortality (MMM) and individuals with intellectual and developmental disabilities (IDD). Starting in Cycle 3 2020, PCORI allotted up to $30M for each of these topics. No changes have been made to the following two priority areas (IDD and MMM) since Cycle 1 2021.

Increasing Access to and Continuity of Patient-Centered Maternal Care

PCORI invites applications for comparative effectiveness research of evidence-based, multilevel, culturally adapted interventions that address barriers in access to and continuity of optimal patient-centered maternal care. This SAE addresses interventions targeting pregnancy, postpartum, and through the 12 months after childbirth with a focus on women from populations that experience significant disparities in outcomes: African American, Native American/Alaska Native, and/or rural. Interventions may include maternal care coordination, education/training for patients/providers, and/or add-on or wrap-around services to assist clinicians and patients in eliminating these disparities. Maternal outcomes must be included. In addition, infant and/or provider outcomes may also be assessed.

Improving Care for Individuals with Intellectual and Developmental Disabilities Growing into Adulthood

PCORI invites applications for comparative effectiveness research of interventions to optimize healthcare transitions from childhood to adulthood and the continuation of patient-centered physical and mental health care. Interventions may include person-centered transition planning; patient, family, caregiver, and provider support during the transfer of care; and support for the continuation of general and specialty adult care. Outcomes may include physical and mental health outcomes; patient, caregiver, family, and provider satisfaction; patient and family/caregiver quality of life; adherence to care; and continuation of care.

COVID-19

PCORI invites applications for comparative effectiveness of strategies to lessen the impact of post-acute sequelae, improve access to vaccines, and mitigate the impact on those disproportionately affected by the COVID-19 pandemic. This SAE focuses on research that can inform critical choices among clinical and policy options that patients, healthcare providers, health systems, policy makers, and other stakeholders will need to make that relate to COVID-19 in a post-pandemic world. While there are not set-aside funds reserved for this topic, this remains a priority area of research for PCORI.  This topic has been updated since Cycle 1 2021.

For all the priority areas below, the social determinants of health (SDoH), as well as disparities in COVID-19 risks and health outcomes, should be considered an important aspect of interventions and/or analyses. The priority areas are:

• Treatment and survivorship of post-acute COVID-19: What are effective interventions and clinical pathways for improving the outcomes of individuals and their families/caregivers experiencing longer-term complications from COVID-19 infection, including neurological, cardiovascular, respiratory, immunological, and rheumatological complications?
• Health system and healthcare delivery management of post-acute COVID-19: What are effective strategies (including primary care strategies) for managing post-acute COVID-19 complications? Are there management strategies of the acute disease related to the prevention (or exacerbation) of the long-term consequences? 
• Strategies to improve outcomes of COVID-19 for disproportionately affected populations: What are effective public health strategies and clinical pathways to improve longer-term outcomes for vulnerable and/or marginalized individuals? What are effective system- or organizational-level responses to prevent or mitigate the impact of COVID-19 in low-income and low-resource settings that serve these populations, such as improving access to vaccines? Disproportionately affected populations include but are not limited to Native Americans or Alaska Natives, African Americans, and other racial, ethnic, or sexual and gender minorities; rural communities; incarcerated populations; people with substance use disorders; people who are homeless or unstably housed; individuals with intellectual, developmental, or physical disabilities; individuals with chronic conditions; low-income women who are pregnant; and individuals facing increased risk of exposure to COVID-19 because they are unable to work remotely.
• Impact of COVID-19-related social isolation and loneliness on health outcomes: What are effective interventions and mitigation strategies to address the longer-term effects of COVID-19-related social isolation and loneliness on health outcomes? Interventions and mitigation strategies include but are not limited to: befriending schemes, individual and group therapies, various shared activity programs, and strategies using information and communication technologies. What strategies can maintain and build on the gains achieved using these technologies? 
  • Studies examining specific features of technology-enhanced interventions (e.g., self-directed or supported; type of support needed; relative intensity of support needed for different populations and health conditions) and tailoring of these features to improve outcomes for the disproportionately affected populations listed above, as well as pediatric populations, are of particular interest.

The research questions articulated in each of the priority areas above are not the only questions of interest; other relevant questions within these priority areas will also be considered.

Study Design Considerations: PCORI encourages the use of diverse study designs to answer research questions. These include multiarm/multistage and other adaptive designs, as well as natural experiments. Hybrid designs, which can provide insight into implementation approaches in the context of evidence generation, are also welcome.

Given the SAE’s focus on longer-term impacts of COVID-19, PCORI recognizes the importance of including data that would allow for the conduct of retrospective analyses and/or the inclusion of baseline data from 2020 (and earlier). Applications that include such data and proposed analyses are strongly encouraged.

In considering the timeline and scope of a proposed study, applicants should consider the importance of generating timely information of relevance for addressing the pandemic. PCORI encourages applications that can generate preliminary results/outcomes early in the conduct of a proposed study.