Key Dates

Related Announcements

NOT-OD-22-134 - Notice of Correction to NOT-OD-22-125 - Notice of Special Interest (NOSI): IMPROVE Initiative: Implementation Science to Advance Maternal Health and Maternal Health Equity

PA-20-183- NIH Research Project Grant (Parent R01 Clinical Trial Required)

PA-20-185- NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
PA-20-200- NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed)
PA-20-194- NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)

PA-20-195- NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)

Issued by

Office of The Director, National Institutes of Health (OD)

Purpose

The Office of the Director of the National Institutes of Health (NIH) announces this new funding opportunity to advance the goals of the NIH Implementing a Maternal health and PRegnancy Outcomes Vision for Everyone (IMPROVE) Initiative. IMPROVE aims to understand the biological, behavioral, environmental, sociocultural, and structural factors that affect pregnancy-related and pregnancy-associated morbidity and mortality and build an evidence base for improved care and outcomes. The initiative promotes research to address health disparities associated with pregnancy-related and pregnancy-associated morbidity and mortality.

The purpose of this Notice of Special Interest (NOSI) is to stimulate dissemination and implementation research on innovative approaches built on evidence-based findings from foundational research on factors that contribute to maternal morbidity and mortality (MMM). This NOSI will support the development and implementation of strategies to inform integrated efforts involving policy and practice changes to improve preconception, pregnancy, perinatal, and postpartum care and advance maternal health and maternal health equity.

Definitions

For the purpose of this NOSI, note the following definitions:

Structural discrimination refers to macro-level conditions (e.g., residential segregation) that limit opportunities, resources, and well-being of less privileged groups (Healthy People 2020, https://www.healthypeople.gov/2020/topics-objectives/topic/social-determinants-health/interventions-resources/discrimination).

Structural racism and discrimination (SRD) refers to structural discrimination on the basis of race/ethnicity and/or other statuses, including but not limited to gender, sexual orientation, gender identity, disability status, social class or socioeconomic status, religion, national origin, immigration status, limited English proficiency, or physical characteristics or health conditions. https://grants.nih.gov/grants/guide/rfa-files/rfa-md-21-004.html

NIH-designated Populations with Health Disparities (HDPs) refers to racial and ethnic minorities, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minorities in the U.S. (see https://www.nimhd.nih.gov/about/overview/).

Health care models refers to the different existing or newly proposed models of patient-centered care. Examples of existing health care models include the Chronic Care Model, the eHealth Enhanced Chronic Care Model, the Community-Based Transition Model, the Nurse Management Model, the Home-Based Model, the Integrated Delivery Systems Model, the Patient-Centered Model and the Value-Based Care Models.

Multi-component refers to the different components of the health care models (e.g., health care system organization, clinician decision support, clinical information system, patient self-management support, delivery system design, and others).

Multi-level refers to the multi-dimensional framework of determinants relevant to understand minority health and address health disparities. This concept is further described under the NIMHD Research Framework (https://www.nimhd.nih.gov/about/overview/research-framework/).

Dissemination research is defined as the scientific study of targeted distribution of information and intervention materials to a specific public health or clinical practice audience. The intent is to understand how best to communicate and integrate knowledge and the associated evidence-based interventions. Gaps include missing critical information about how, when, by whom, and under what circumstances evidence spreads throughout communities, organizations, front line workers, and consumers of public health and clinical services.

Implementation research is defined as the scientific study of the use of strategies to adopt and integrate evidence-based health interventions into clinical and community settings to improve individual outcomes and benefit population health. Implementation research seeks to understand the behavior of practitioners and support staff, organizations, consumers and family members, and policymakers in context as key influences on the adoption, implementation, and sustainability of evidence-based health interventions and guidelines (e.g., Community Guide to Preventive Services, U.S. Preventive Services Task Force, and clinical and professional societies' recommendations and guidelines).

Dissemination and Implementation (D&I) Research Broadly, studies in this field typically involve both interdisciplinary cooperation and trans-disciplinary collaboration, utilizing theories, empirical findings, and methods from a variety of fields. Relevant fields include but are not limited to the following: information science, clinical decision-making, organizational and management theory, economics, individual and systems-level behavioral change, public health, business and public administration, statistics, anthropology, epidemiology, learning theory, engineering, and marketing. D&I research will often include significant and ongoing collaboration with stakeholders from multiple public health and/or clinical practice settings as well as consumers of services and their families/social networks.

For additional resources on dissemination and implementation research, including information on D&I training opportunities, funded studies, key references, past workshops and conferences, visit: http://cancercontrol.cancer.gov/is/ and https://prevention.nih1.gov/research-priorities/dissemination-implementation. For additional information on MMM and the IMPROVE initiative at NIH, please visit https://orwh.od.nih.gov/mmm-portal and https://www.nih.gov/research-training/medical-research-initiatives/improve-initiative.

Background

MMM in the United States is the highest among developed nations. The CDC reports that in 2020, 861 women were identified as having died of causes related to pregnancy in the United States (including deaths due to COVID-19), compared with 754 in 2019. Mortality rates for Black women (40.8 mortality incidences per 100,000 births) were more than 320% higher than White (12.7) women, and Native American women (29.7) demonstrated rates nearly 240% higher. It is estimated that about one-third of pregnancy-related deaths occur during pregnancy, one-third occur during or in the week after delivery, and one third occur between 1 week to 1 year postpartum.

In addition, approximately 50,000 women experience severe maternal morbidity (SMM). Causes of maternal morbidity and SMM are multifaceted and vary widely by state. In the United States, the leading causes are cardiovascular disease, hypertension, thromboembolism, hemorrhage, infection, and mental health related conditions, including substance use, suicide, and violence. Significant contributing factors include comorbid conditions (e.g., obesity, mental health, and substance use disorders) and structural and health care system factors. It is estimated that 60 70 percent of maternal deaths in the United States are preventable.

High rates of pregnancy-related and pregnancy-associated morbidity and mortality disproportionately affect specific racial/ethnic populations. Black or African American (AA) and American Indian/Alaska Native (AI/AN) women are 2 to 4 times more likely to die from pregnancy-related causes compared to White women. Furthermore, Black or African American, Hispanic/Latina, Asian, Pacific Islander, and American Indian/Alaska Native women all have higher incidence of SMM compared to White women.

Several factors affect MMM, including, age, disabilities, geographical location, and SDoH (including education, structural discrimination and racism, and socioeconomic standing). Psychosocial factors and SDoH (e.g., stress, social isolation, mental health, intimate partner violence, substance use, quality of life, etc.) contribute to pregnancy-related and pregnancy-associated morbidity and mortality, particularly among women from racial/ethnic minority groups, less privileged socioeconomic status groups, and other underserved populations. Structural discrimination and racism (e.g., residential segregation that restricts access to healthcare and healthy living environments) have profound negative impacts on maternal health and well-being outcomes during pregnancy and up to one year postpartum. Structural factors that contribute to negative impacts include occupational segregation and barriers which limit access to health insurance, sick or maternity leave, and healthy working conditions (inclusive of contributing policies and organizational psychology that impact these barriers); and criminal justice inequities that lead to a greater risk of incarceration or fewer legal protections for women who are victims of violence, amongst others. Therefore, implementing multifaceted strategies to address preventable contributors to MMM in under-represented HDPs, and conducting novel systems research examining the health care and community approaches to maternal wellbeing have the potential to drastically reduce pregnancy-related maternal deaths and decrease maternal morbidity.

To address morbidity and mortality related to and associated with pregnancy, the NIH launched the Implementing a Maternal health and PRegnancy Outcomes Vision for Everyone (IMPROVE) initiative. IMPROVE supports research to reduce preventable causes of maternal deaths and improve health for pregnant and postpartum women before, during, and after delivery. The initiative focuses on addressing the leading causes of MM and pregnancy-associated and pregnancy-related morbidity. IMPROVE places particular emphasis on understanding the contributing factors and eliminating the adverse maternal outcomes related to social determinants of health disproportionally affecting populations that experience health disparities.

IMPROVE seeks to cover the full spectrum of research related to MMM, from foundational and mechanistic science, and interventional approaches through to implementation and dissemination. While there are a variety of evidence-based practices, interventions, and clinical guidelines available to address many factors contributing to MMM, best practices are not available and/or have not been equitably implemented or delivered. Some approaches may not yet be sufficient to address root causes for populations experiencing health disparities.

Specific Objectives

With this NOSI, NIH invites research grant applications to plan and carry out projects to disseminate and implement evidence-based interventions or practices into public health, clinical, and community (e.g., workplace, school, place of worship) settings to advance a holistic approach to improve maternal health and maternal health equity in populations disproportionately impacted by MMM. Applicants are encouraged to propose studies that include interventions with demonstrated efficacy for the target populations and demonstrated effectiveness in real-world settings. Strategies should include plans to identify and overcome barriers and facilitators and adapt to local contexts.

Evidence-based practice areas of interest include behavioral interventions; prevention, early detection, diagnostic, treatment, and management interventions; and quality improvement programs, with emphasis on culturally and linguistically appropriate strategies for NIH-designated HDPs (https://www.nimhd.nih.gov/about/overview/). Of particular interest are evidence-based practices with demonstrated effectiveness that address MMM related to social determinants of health, stress-, cardiovascular-, metabolic-, infectious-, mental health-, and infection and immunity-related causes.

Multidisciplinary, systems, and community-partnered implementation science approaches utilizing existing community-engaged partnerships to reduce morbidity and mortality related to and associated with pregnancy encompassing the preconception, pregnancy and post-partum periods are encouraged.

Applicants may propose approaches for the identification, development, testing, deployment, evaluation, and/or refinement of implementation and dissemination strategies. Projects may include pilot/feasibility studies or full-scale implementation or dissemination projects.

NIH plans to implement in fiscal year 2023 several activities to enhance research to advance maternal health. In order to maximize the impact and leverage any resources generated from projects funded in response to this NOSI, preference will be given to projects that can be achieved within a three-year timeframe (R21 and R03 applications are limited to project periods of two years or less). Specific to R01 applications, the maximum project period that will be accepted is three years.

Implementation of evidence-based interventions

Areas of interest include but are not limited to:

• Strategies for implementing and testing effective, multiple evidence-based maternal health care practices (e.g., Alliance for Innovation on Maternal Health (AIM) patient safety bundles) within community, clinical, or hospital settings, and health care models to meet the needs of complex patients, diverse systems of care, diverse populations, and geographical areas of greatest need.
• Strategies for improved dissemination of evidence-based maternal health prevention, screening, early detection, and diagnostic interventions, as well as effective treatments, clinical procedures, or guidelines into existing health care systems.
• Strategies to incorporate community-identified needs and patient reported outcomes (PROs) and patient preference information (PPI) of preconception, pregnant, and post-partum women in the design, implementation, and dissemination of pregnancy- and maternal health care-related practices.
• Implementation studies addressing different components of the health care models (e.g., health care system organization, clinician decision support, clinical information system, patient self-management support, delivery system design)
• Strategies targeting organizational structure, climate, culture, and processes to enable dissemination and implementation of clinical/public health information and effective clinical/public health interventions to improve maternal health and maternal health equity.
• Development of innovative approaches and partnerships with local community and government organizations (i.e., community action teams) to accelerate implementation of evidence-based policies that impact maternal health and aim to reduce or eliminate maternal health disparities.
• Development and testing of dissemination and implementation strategies to improve maternal health and outcomes that are risk-specific for NIH-designated U.S. HDPs, which currently include Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minorities (https://www.nimhd.nih.gov/about/overview/).

Build evidence to address gaps in maternal health implementation science

Areas of interest include but are not limited to:

• Use of quantitative, semi-quantitative, and qualitative methods to identify barriers and obstacles preventing implementation of effective evidence-based maternal health care practices.
• Evaluation of existing evidence-based interventions and/or evidence-based practices developed to address population specific risk and protective factors, including risk factors/conditions contributing to or resilience factors (e.g., nutrition, stress) which prevent pregnancy-associated and pregnancy-related MMM. This includes SMM and maternal morbidity during the pre-pregnancy, pregnancy, and postpartum periods.
• Testing the impact of existing care models with interventions designed to address structural determinants of health and health disparities, including holistic or integrated care models, coordination of care, stress management, and preventive interventions in high-risk populations and for complicated pregnancies.
• Evaluation of evidence-based standards or protocols for maternal care tailored for women with comorbid conditions, including diabetes, obesity, substance use disorder, cardiovascular, mental health, and autoimmune diseases.
• Testing culturally tailored/culturally sensitive models of care to reduce SRD among high-risk populations to prevent pregnancy-associated and pregnancy-related MMM and SMM.
• Evaluating evidence-based multi-level or multi-component interventions and/or evidence-based practices to address SRD affecting preconception and/or perinatal care.

Key Considerations

Collaborative Research. Given the range of expertise that may be needed for conducting dissemination and implementation research, applicants are encouraged to leverage multidisciplinary teams of scientists and stakeholders.

Community Engagement. Investigators proposing implementation projects should engage community partners at the onset and throughout the project who can successfully advise and provide feedback to implementation strategy development and testing teams. This type of involvement may include advice from the community, partnership in research, and shared leadership.

All projects are encouraged to leverage existing resources and expand community partnerships (e.g., Tribal governments and agencies, academic, private, safety-net health systems, other health systems, grassroots organizations, public health departments, community and faith-based organizations, and schools or childcare settings) to complete the study aims. Approaches such as team science, community-engaged research, participatory action research, and related approaches may be used to engage stakeholders and underserved populations throughout the research process. Study budgets should include funds for the community partners to be fully engaged and successfully participate in research design and implementation.

Key characteristics of implementation (D&I) research:

• Consider and characterize the multi-level context and environment in which the proposed research will be conducted.
• Develop and/or use appropriate D&I related outcomes, measures, and analyses. Applicants are encouraged to review available resources and use standard measures and validated instruments where possible, rather than developing their own measures for each study.
• Incorporate outcomes relevant to patients, consumers, families, practitioners, administrators, and/or policymakers as applicable.

All applications must address how the proposed research impacts maternal health in HDPs and how it may contribute to achieving maternal health equity. Studies that examine or address multiple levels and domains of influence affecting maternal health, care, and access are strongly encouraged. (See the NIMHD research framework: https://www.nimhd.nih.gov/about/overview/research-framework/nimhd-framework.html for more info). Projects are expected to incorporate research strategies to address individual and structural social determinants of health (SDOH) (https://health.gov/healthypeople/objectives-and-data/social-determinants-health) that present barriers to adequate and timely health care.

To accelerate research, NIH encourages investigators to leverage ongoing significant investments made on domestic resources, cohorts, and research infrastructure studying pregnant women. NIH expects that investigators supported though this NOSI will share their findings, approaches, methods and results with the anticipated new NIH initiatives established to advance maternal health and maternal health equity. Further, NIH intends to provide further opportunities for Investigators supported through this NOSI to interface, collaborate and leverage resources, data and methodologies that are created through the planned new initiatives.

Data Harmonization

To maximize comparisons across datasets or studies and facilitate data integration and collaboration where appropriate to study aims, researchers funded through this NOSI are strongly encouraged to use the following data resources below. In particular, the use of the collections detailed below is strongly encouraged where applicable:

NICHD Promoting Data Harmonization to Accelerate COVID-19 Pregnancy Research, which encompasses a collective contribution of NIH extramural and intramural investigators from the relevant research community (see list of contributors on page 4 of the referenced document).

Data Harmonization for Social Determinants of Health (SDOH), COVID-19, mental health, and other relevant measures via the PhenX Toolkit: Investigators involved in human-subject studies are strongly encouraged to employ a common set of tools and resources that will promote the collection of comparable data on SDOH and mental health across studies. In particular, human-subject studies should incorporate SDOH measures from the Core and Specialty collections that are available in the Social Determinants of Health Collection of the PhenX Toolkit (https://www.phenxtoolkit.org/collections/view/6) and the Psychosocial and Mental Health toolkit (https://www.phenxtoolkit.org/sub-collections/view/34

Application and Submission Information

Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcement through the expiration date of this notice.

PA-20-185- NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
PA-20-183- NIH Research Project Grant (Parent R01 Clinical Trial Required)
PA-20-200- NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed)
PA-20-195- NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)
PA-20-194- NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)

When developing applications in response to this NOSI, all instructions in the SF424 (R&R) Application Guide, must be followed, with the following additions:

For funding consideration, applicants must include NOT-OD-22-125 (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative. Foreign institutions may not apply, and foreign components are not allowed.

Review Process

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed. Applications submitted in response to this NOSI will be reviewed by a Center Scientific Review Special Emphasis Panel. Advisory Council Review is not applicable to applications received in response to NOT-OD-22-125. Council will be notified of any awards that are made in response to this NOSI

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

Inquiries

Melissa Laitner, PhD

Office of the Director

Email: [email protected]