Maternal Morbidity and Mortality Topical PCORI Funding Announcement -- Cycle 1 2024

Notice of Upcoming PCORI Funding Announcement

The Patient-Centered Outcomes Research Institute (PCORI) intends to issue a Topical PCORI Funding Announcement (PFA) on January 9, 2024, seeking to fund high-quality, patient-centered comparative clinical effectiveness research (CER) projects that focus on maternal morbidity and mortality (MMM). This preannouncement provides potential applicants additional time to identify collaborators; obtain patient and stakeholder input on potential studies; and develop responsive, high-quality proposals. 

Research Initiative Highlights

The United States ranks lowest among high-income countries in parameters for maternal health with a maternal mortality rate of 32.9 per 100,000 births. The main contributors to maternal mortality are mental health complications (including suicide and drug overdose), hemorrhage, cardiac and coronary conditions, and infection. However, the main causes for mortality differ between races and ethnicities, with mental health being the largest contributor among non-Hispanic White and Hispanic birthing people and cardiac and coronary conditions being the largest contributor among Black birthing people. Severe maternal morbidity (SMM), which includes unexpected outcomes of labor and delivery that result in significant short- or long-term consequences to a person’s health, has also been steadily increasing over the years with around 60,000 people in the United States affected each year. SMM is an important risk factor for maternal death. Both maternal mortality and SMM are associated with a high rate of preventability. Research based on data from Maternal Mortality Review Committees from 36 states shows that 84.2 percent of deaths were determined to be preventable.

This funding announcement seeks studies that propose to address patient-centered CER questions that will fill important evidence gaps in maternal health. Maternal health research is defined as follows: the study of the physical, mental and social health of individuals related to pregnancy (pre-conception, pregnancy, childbirth and the first year postpartum). Because an individual’s pre-conception health status is associated with health during and following pregnancy, and interventions to improve pre-conception health may reduce morbidity and mortality during and following pregnancy, the pre-conception period is included in PCORI’s definition of maternal health.

Primary outcomes must include a maternal health outcome that is clinically meaningful and measured at least either during pregnancy or in the first year postpartum and longer if appropriate. Primary outcomes of interest may include MMM; SMM; condition-specific outcomes; healthcare utilization, including readmission and emergency department visits; labor characteristics (e.g., preterm labor, induction of labor, use of analgesia/anesthesia, C-section).

PCORI is particularly interested in submissions that address the following Special Areas of Emphasis (SAEs). The purpose of identifying these SAEs is to encourage submissions to these areas, not to limit submissions to these topics. Applicants addressing one of the below SAEs should identify the area that is best associated with their research approach:

1. Optimal diagnosis, prevention and treatment strategies for high-risk pregnant people: Individuals with a high-risk pregnancy are at increased risk of maternal mortality and SMM. Historically, high-risk pregnant individuals with preexisting mental health conditions, cardiovascular disease (CVD) or other indications have been excluded from clinical research due to perceived safety issues, resulting in a lack of best practice guidelines for those who need it most. Therefore, PCORI is seeking to fund CER that will identify the optimal diagnosis, prevention and treatment strategies for individuals with high-risk pregnancy and their fetus, including clinical, care delivery and care coordination strategies during pregnancy and the postpartum period. A high-risk pregnancy is one in which the pregnant individual or fetus or both are at higher risk for health problems during pregnancy or postpartum than in a typical pregnancy (e.g., pregnancies of people with chronic health conditions such as bipolar disorder, high blood pressure or diabetes). A high-risk pregnancy requires special attention and monitoring during the pregnancy and in some circumstances may require medical intervention before the birth.
2. Populations experiencing disparities in maternal health outcomes: Significant disparities for maternal outcomes have been reported for Black, Indigenous American, Hispanic people; people living in rural areas; and people of lower socioeconomic status. Black and Indigenous American populations are almost three times as likely to die compared to non-Hispanic White people. They also experience the highest rates of pregnancy complications and SMM. Thus, PCORI is seeking to fund rigorous, adequately powered randomized controlled trials (RCTs) and/or well-designed observational studies comparing interventions to improve maternal health for groups more often underserved or experiencing the greatest disparities in health outcomes, including Black, Indigenous American, Hispanic, rural and low socioeconomic status populations.
3. Observational CER examining variations in healthcare practices: PCORI is interested in rigorously designed CER that looks at various healthcare practices, interventions and strategies that are a result of, for example, policies or initiatives such as those sponsored by medical specialty societies or through public health campaigns that differ across geographies or over time. Please note, appropriate comparators should not focus on policy implementation itself. Studies must focus on one or more of the following comparisons of interest: utilization of the diverse perinatal care workforce, systems approaches that may enhance access to maternal and perinatal care, variations in the way maternal healthcare is delivered, and clinical approaches to increase the quality of maternal and perinatal care.

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 not be considered responsive nor will studies focused on the development of research methods. Applicants should propose well-justified MMM-related outcomes that are clinically meaningful and considered important by patients and relevant healthcare stakeholders and that can be impacted by the proposed intervention within the study duration.

Applicants should consider, as appropriate, the full range of MMM-related clinical and patient-centered outcomes data relevant to patients and members of the broader health and healthcare community. 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.