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WASHINGTON, D.C. — The Patient-Centered Outcomes Research Institute (PCORI) today announced funding awards totaling $80.5 million to support four new, ambitious patient-centered comparative clinical effectiveness research (CER) studies focused on both the health care and social factors that contribute to inequities in maternal morbidity and mortality. The trials are among 30 CER studies and related projects recently approved for PCORI funding.

Awarded through an innovative PCORI funding opportunity known as Partner for its focus on partnering research institutions and community organizations to pursue novel approaches to health equity research, these four CER studies will focus on populations disproportionately experiencing adverse maternal health outcomes, including Black people, Hispanic and Latin American individuals, those living in rural areas and individuals with lower incomes.

A combination of elements distinguishes the four studies from standard clinical trials. For each study, dual principal investigators from research institutions and community organizations with established and meaningful local relationships will co-lead assessments of approaches intended to address the complex health challenges that impact maternal health in different communities. Recognizing that these challenges are influenced by factors beyond clinical care, these studies will evaluate multicomponent interventions that address both health care and social determinants of health. Each of these studies will have a planning phase of up to one year and a research phase of up to five years.

     Nakela L. Cook, M.D., MPH

“The usual approaches to health research and health care have not sufficiently addressed the alarming and worsening national crisis of maternal death and severe illness,” said PCORI Executive Director Nakela L. Cook, M.D., MPH. “Patient-centered comparative clinical effectiveness research that responds to the many challenges concurrently facing pregnant individuals and those who care for them has the capacity to answer questions about which combinations of approaches can best resolve some of these complex maternal health care challenges that have for too long defied solutions.”

The studies will be conducted across a broad swath of the United States, including rural and urban areas and states in the Northeast, Midwest, Mid-Atlantic and the South. They will compare a range of practice-level and community- and home-based interventions that address common, frequent challenges facing pregnant individuals and new mothers.

  • Two studies will address maintaining a healthy maternal weight to prevent delivery or postpartum complications among primarily low-income patients in Arkansas and New York City, respectively. Interventions that the studies will compare include patient-selected social needs supports, such as grocery delivery or transportation to medical appointments, and social service navigation driven by community-health-workers.
  • A third study to be undertaken in 10 counties in North Carolina will track the results of a multipronged program that includes home-based blood pressure monitoring, provider education and support for community health workers to reduce hypertensive disorders of pregnancy, one of the major causes of serious health problems among birthing individuals.
  • A fourth study will focus on mood and anxiety disorders that affect one in five pregnant and postpartum individuals and compare how well a practice-level intervention and a peer support program improve symptoms of depression and anxiety among patients receiving care in the perinatal period at clinics in seven states.

Each of these studies will generate evidence to inform which approaches work best, for whom and in what circumstances. Details about the individual studies can be found via this link.

     Harv Feldman, M.D., MSCE

“These funding awards mark an important advancement of PCORI’s longstanding leadership in engaging patients and those who care for them in all aspects of comparative clinical effectiveness research to ensure that results are relevant, useful and impactful,” said PCORI Deputy Executive Director for Patient-Centered Research Programs, Harv Feldman, M.D., MSCE. “We look forward to seeing the impact the studies’ findings will have for maternal health across the United States, particularly among populations that continue to disproportionately experience adverse outcomes.”

Details of all the newly funded studies and projects are available on PCORI’s website. All funding awards were approved pending a business and programmatic review by PCORI staff and the issuance of formal award contracts. With these latest awards, PCORI has invested more than $4.5 billion to fund patient-centered CER and support other projects.


See related news:

PCORI approves $225 million in funding for dozens of health research studies and related projects

About PCORI

The Patient-Centered Outcomes Research Institute (PCORI) is the nation’s leading funder of patient-centered comparative clinical effectiveness research (CER). By comparing two or more health or healthcare approaches, CER generates evidence that helps people make better-informed decisions and improves healthcare delivery and outcomes. PCORI takes a holistic approach to its work, ensuring that patients and other health decision makers are engaged as partners throughout the research process, supporting dissemination and implementation of results in practice and strengthening clinical research infrastructure to advance patient-centered CER. PCORI is an independent, non-profit organization authorized by Congress.

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