Key Dates

Related Announcements

PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

Issued by

National Institute on Minority Health and Health Disparities (NIMHD)

Purpose

Purpose

This Notice of Special Interest (NOSI) invites applications for administrative supplements to eligible NIMHD-funded Research Centers in Minority Institutions (RCMI) U54 awards to build research capacity to support a practice-based clinical research network addressing health care for populations that experience health disparities.

Background

A practice-based clinical research network (PBRN) is a group of ambulatory care clinical practices devoted principally to the care of patients that investigates empirical research questions related to improving the quality of primary care, addressing questions on implementation of best practices, and addressing problems that often require multi-level approaches. PBRNs are uniquely positioned for dissemination and implementation research and comparative effectiveness research. The RCMI-supported PBRN is intended to provide research infrastructure that allows for systematic inquiry to improve the health care and health care systems that provide care for NIH-designated United States health disparity populations [e.g. racial and ethnic minority populations, sexual and gender minority groups, underserved rural populations, and socioeconomically disadvantaged populations (https://www.nimhd.nih.gov/about/overview/)], and support a network of clinicians with representation from backgrounds that are underrepresented in health-related sciences on a national basis (http://www.nsf.gov/statistics/wmpd/). PBRNs are ideal for conducting a wide variety of physician and patient studies and are a rich source of medical data. For the purposes of this FOA, the RCMI-supported PBRN will involve multiple RCMIs providing infrastructure to establish local or regional consortia of ambulatory primary care settings that serve patients from populations that experience health disparities to participate within the network. Of priority are primary care settings linked to the RCMI academic health centers and Federally Qualified Health Centers (FQHCs) that serve a high proportion of patients with public insurance (Medicare, Medicaid, CHIP) or no insurance.

PBRNs draw on the experience and insight of practicing clinicians to identify and frame research questions that can improve the practice of care. By linking these questions to rigorous research methods, PBRNs produce research findings that are immediately relevant to the primary care clinician and more easily translated into everyday practice and integrated into health care systems. To date, many of these PBRNs consist of practices within high resource health care settings. This initiative proposes to expand this capacity by enabling practices such as FQHCs and other practices that serve populations that experience health disparities to form a PBRN. The goal of forming the RCMI-supported PBRN is to frame research questions based on health equity and improve the practice of care to reduce and eliminate health disparities.

The health care systems and clinicians that provide care for patients from populations that experience health disparities should help drive the research questions based on urgent practice priorities, including addressing disparities in access, quality, and outcomes of treatment and services. Further, the RCMI-supported PBRN will support a network comprised of clinicians with representation from groups underrepresented in health-related sciences to examine important research questions about the patient-clinician communication and relationship as well as key constructs such as conscious and unconscious bias, trust, cultural competency, shared decision-making, the effects of interpreter-mediated visits compared to language concordant visits, the role of race or ethnic concordance in affecting interpersonal processes of care, and other aspects of the role of the clinician on health outcomes for populations affected by health disparities. Studies conducted through the RCMI-supported PBRN will be pragmatic and deployment-focused, incorporating stakeholder perspectives and criteria used for decision making. The goal of the studies conducted by the network is to inform, develop, and test interventions and service delivery strategies that are feasible, scalable, and sustainable, and will ultimately improve routine health care services for populations that experience health disparities.

Research Objectives

Supplements awarded through this NOSI are intended to provide support to build capacity at RCMIs to provide scientific, administrative, infrastructure, and logistical support to enable regional and local consortia of health care practices and health care systems to participate in the RCMI-supported PBRN. The application should provide an overview of the target patient populations, clinician characteristics, and practice types and settings for which the RCMI will increase PBRN consortium capacity. The application should also identify potential health conditions intended to be the focus of the research questions their consortium will have the capacity to address.

The application should describe the approach to build the scientific and logistical capacity, as well as the needed resources necessary to establish an RCMI-supported PBRN consortium of primary care clinicians and health systems. A detailed description of the approach to develop collaborative agreements or memoranda of understanding, identifying capacity needs within each participating practice and health care system to enable research capacity and collaboration across systems, and strategies to inform research questions, recruit practices, execute studies, and disseminate successful practices and products developed through network studies should be included.

For each practice and health care system identified as potential member of the consortium, the application should provide data about patients cared for including the geographic service areas, key demographic characteristics including race/ethnicity and insurance status of patients, practice settings, and the demographic characteristics including race/ethnicity of the clinicians providing care (MDs/DOs, PAs, or NPs). Letters of support are required from these practices for their participation in this proposal.

Applicable PBRN sites are those that provide ambulatory primary care, including family medicine, general internal medicine, and general pediatrics, as well as cognitive subspecialties with a component of chronic disease such as rheumatology, endocrinology (especially diabetes), general cardiology, asthma/chronic lung disease, geriatrics, and general gynecology. Of particular interest are practices and health care systems that serve populations that experience health disparities, for example, FQHCs and the ambulatory care settings of academic institutions.

General Requirements

The RCMI-supported PBRN, eventually composed of multiple local and/or regional consortia of practice and health care systems, is expected to function as a resource to be able to support the conduct of research through robust infrastructures that can be leveraged to (1) efficiently and rapidly identify, recruit and enroll clinicians that serve diverse patient populations into health services and clinical research; (2) harmonize electronic health record (EHR) data across multiple integrated systems for common analyses, using common data elements and adhering to principles of data storage; (3) develop, test, and deploy interventions, workflows, and decision support systems; (4) develop and test strategies to address health care disparities within ambulatory primary care settings, including strategies for improving patient-clinician communication; and (5) facilitate research that addresses emergent health conditions in health disparity populations such as long term sequelae of COVID-19 as well as chronic diseases such as diabetes, asthma, osteoarthritis, and depression. At a future time, the RCMI-supported PBRN will increase capacity for the collection, storage, and analysis of biologic and/or genetic material.

Applications will propose a needs assessment and feasibility study necessary to design the capacity and infrastructure requirements to enable local or regional primary care providers and health systems to participate within the PBRN. For the purposes of this NOSI, the needs assessment and feasibility study can focus on one academic health center or one system plus some of the FQHCs in the area. These requirements include capacity and infrastructure to:

• Build and maintain established relationships with relevant constituent groups (e.g., patients, clinicians, administrators, payors, relevant federal and state agencies) to inform research questions, gain input about the feasibility and clinical interest of research topics, and attend to front-end infrastructure to secure stakeholder commitment to adopt, implement and sustain successful practices and products developed within this Network, including developing a plan for equitable practitioner and patient compensation system.
• Maintain accessibility to relevant patient, clinician, and health system data, including the capacity for study-specific data management systems that allow for electronic data capture in practices and utilize flexible and innovative technologies to capture research data, including the capability to accomplish research participant follow-up independent of in-office visits, and enabling collection of common data elements (https://nexus.od.nih.gov/all/2021/06/24/common-data-elements-increasing-fair-data-sharing/) and data sharing (https://grants.nih.gov/grants/policy/data_sharing/). Studies involving primary data collection with human participants are strongly encouraged to use a set of Common Data Elements (CDEs) to standardize the collection of data and ensure that data can be aggregated and compared across study populations, and incorporate SDOH measures from the Core and Specialty collections that are available in the Social Determinants of Health Collection of the PhenX Toolkit (www.phenxtoolkit.org). Considerable assessment may be required to build capability to be able harmonize electronic health records (EHRs), utilize CDEs, and establish protocols for data security and data sharing.
• Coordinate and facilitate the conduct of research within their consortium of primary care clinicians and health care systems, such as infrastructure for human subjects protections including processes to execute single IRB oversight of protocols, provide practitioners and office/clinic staff with responsible research conduct training required by NIH and IRBs; provide study-specific training to practitioners and office/clinic staff, enabling them to recruit, enroll, and collect data on their patients in their offices/clinics; developing systems to assist practitioners in maintaining high rates of patient enrollment and retention; and performing quality management activities and monitoring study execution by practitioners and office/clinic staff.
• Develop and test strategies (using implementation science) to encourage adoption, quality, scale-up, and sustainability of new innovations and existing best practices, including processes for recruiting practices and providers and systems for managing study development/implementation progress.

Projects must examine NIH-designated United States health disparity populations, e.g. racial and ethnic minority populations, sexual and gender minority groups, underserved rural populations, and socioeconomically disadvantaged populations (https://www.nimhd.nih.gov/about/overview/).

Applications not responsive to this NOSI:

• Projects that do not include a focus on primary care practices or health care systems that serve one or more NIH-designated populations that experience health disparities in the United States.
• Projects conducting research outside of the U.S. or its territories and possessions, the Commonwealth of Puerto Rico, or the Trust Territory of the Pacific Islands, or requesting foreign components.
• Projects that propose clinical trials.
• Projects supplementing awards that are not eligible under this NOSI.
• Projects that are not within the scope of the original approved parent RCMI project and any expansion due to a competitive revision.

Applications nonresponsive to these terms will be withdrawn for this NOSI initiative.

Description of circumstances for which administrative supplements are available.

Application and Submission Information

Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.

• PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

All instructions in the SF424 (R&R) Application Guide and PA-20-272 must be followed, with the following additions:

• Individual requests can be no more than $350,000 in direct costs with a maximum project period of one year, not including consortium indirect costs.
• Application Due Date(s) – August 25, 2021 ,, by 5:00 PM local time of applicant organization.
• For funding consideration, applicants must include “NOT-MD-21-025” (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.
• Requests may be for one year of support only.
• Requests may be for up to one year of support (if sufficient time is left to complete the activities proposed within the parent award’s current project period). The supplement project period must be within the currently approved project period of the parent award.
• Only active Research Centers in Minority Institutions (RCMI) U54 awards supported under RFA-MD-17-003, RFA-MD-17-006, RFA-MD-18-012, or RFA-MD-20-006 are eligible.
• To be eligible, the parent award must be active when the supplement application is submitted (i.e., within five years of the start date of the originally reviewed and approved project period of the existing parent RCMI’s competitive segment; or if applicable, within the originally reviewed and approved project period of a competitive revision).
• The supplement proposed must be within the scope of the original approved parent RCMI project and any expansion due to a competitive revision.
• The Research Strategy section of the application is limited to 6 pages.
• Applicants are strongly encouraged to notify the program contact at the Institute supporting the parent award that a request has been submitted in response to this FOA in order to facilitate efficient processing of the request.

Inquiries

Please direct all inquiries to:

Scientific/Research Contact(s)

Rada K Dagher, Ph.D., M.P.H.
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-451-2187
Email: rada.dagher@nih.gov

Nancy L. Jones, Ph.D., M.S.
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8945
Email: nancy.jones@nih.gov

Financial/Grants Management Contact(s)

Priscilla Grant
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: pg38h@nih.gov