National Human Genome Research Institute (NHGRI)
The NHGRI intends to promote a new initiative by publishing a Notice of Funding Opportunity (NOFO) to solicit applications to support a network of genomic-enabled learning health systems (gLHS). These health systems will identify and improve approaches for clinical integration of genomic information in a virtuous cycle of implementation, assessment, refinement, and re-implementation. Specifically, this initiative would: 1) support 4-6 established or emerging gLHS clinical sites to share their genomic medicine implementation practices and identify those most suitable for cross-network implementation; 2) use these practices to conduct 2-4 network-wide pilot implementation projects and evaluate their impact; and 3) develop and refine successful gLHS implementation strategies as resources that can be broadly shared and adopted, including in resource-limited settings.
This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects, and to allow potential applicants with relevant expertise and insights to consider applying for this new NOFO.
The NOFO is expected to be published in late summer 2023 with an expected application due date in fall 2023.
This NOFO will utilize the U01 activity code; clinical trial is required. Details of the planned NOFO are provided below.
A learning health system (LHS), also called a rapid-learning health system, is one in which internal data and experience are systematically integrated with external evidence and the resulting knowledge is put into practice. In an effective LHS, generalizable knowledge can potentially be captured from every patient encounter and delivered to clinicians to modify their practice, ideally allowing them to learn from what they do and do what they learn. Ultimately, the goal of an LHS is to enable health systems to rapidly fill evidence gaps and refine them as needed to improve the quality of care delivered in a virtuous cycle of continuous quality improvement.
Genomic information can be integrated at any step in this process to produce genomic-enabled learning health systems (gLHS), which can facilitate rapid incorporation and evaluation of genomic-informed care. A few examples include genomic identification of actionable genetic conditions, EHR integration of genomic information for genetics-care delivery, EHR-identification of monogenic disorders, genome sequencing in critically ill infants, and targeted pharmacogenetic testing. Interoperability of integrated genomic data across health systems is also necessary, and significant strides have been made, as exemplified by the successful deployment of the Genetic Cancer Risk Detector (GARDE) program.
The potential for gLHS to move genomic discoveries rapidly into clinical care through systemic implementation was highlighted in the NHGRI 2020 Strategic Vision, particularly the possibility of extending gLHS studies across multiple health systems to reveal common challenges and solutions. To explore successful implementation models and possibilities for collaboration among them, NHGRI convened Genomic Medicine XIV – Genomic Learning Healthcare Systems in August 2022. Establishing a network to promote sharing and collaboration across gLHS was a key recommendation of that meeting.
Objectives and Scope
This NOFO will establish 1 gLHS coordinating center (CC) that will work with 4-6 clinical sites (CS ) to form a gLHS Network that will share and develop current best practices for implementing, evaluating, refining, and re-implementing genomic medicine interventions. The Network will identify 2-4 pilot implementation projects in the first year and implement and evaluate these projects in years 2-4. The Network will assess the impact of integration and implementation, using lessons learned to refine tools and resources for wider dissemination, in year 5. The CC will be responsible for coordinating sharing and implementation efforts across the sites through in-person meetings, conference calls, working groups, etc. It will also compile and organize selected best practices and methods (for example, for EHR integration, results reporting, decision support, provider education, community engagement) for broader distribution to a wide range of healthcare settings.
Pilot implementation projects
Network-wide genomic medicine interventions will be selected and designed to demonstrate and enhance the ability to exchange genomic results, recommendations, and workflows across CS. They should have significant evidence supporting the value of or need for broader implementation from existing programs at the CC, CS, and/or from similar systems. Other criteria for selecting projects will be defined by the Network, but key aspects include interoperability and assessment of the ability for a patients genomic information to follow them across multiple providers.
Evaluation and best practices
Assessment metrics for selected projects should include outcomes of value to patients, communities, health systems, payers, clinicians, and other stakeholders. The evaluation and findings will be used to refine approaches and develop gLHS implementation resources, which should include approaches for: integrating genomic results in the EHR, real-time monitoring of or dashboarding the status of implementation, and tracking the outcomes of interventions.
Broadening participation in gLHS
gLHS products should be feasible across a range of health systems, including low-resource settings and genetically diverse populations. Implementation resources produced by the Network will be designed to help other providers adopt gLHS approaches and potentially facilitate their participation in this and similar networks.
This Notice encourages investigators with expertise and insights into LHS and gLHS to consider applying to this new NOFO. CC applicants will be expected to:
This RFA will be NHGRIs first initiative focused on exploring and developing gLHS. Other NHGRI efforts focus on implementation and evidence generation without the iterative virtuous cycle of LHS.
$1.6M per year
$1.6M per year
Applications are not being solicited at this time.
Please direct all inquiries to:
Robb Rowley, M.D.
National Human Genome Research Institute (NHGRI)
Telephone: (301) 827-9126