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The Yale Population Genomic Screening Pilot: Outcomes and Best Practices for Implementation Across Different Clinical Settings.

Award Number: U01HG014624
ORGANIZATION: NATIONAL HUMAN GENOME RESEARCH INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 06/18/2026
PERIOD OF PERFORMANCE END DATE: 03/31/2031

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The Yale Population Genomic Screening Pilot: Outcomes and Best Practices for Implementation Across Different Clinical Settings. - SUMMARY: Population genomic screening (PopGS) can identify individuals at risk for developing certain diseases, as well as individuals with early disease onset, long before they would otherwise come to clinical attention. However, several major hurdles exist that prevent large-scale implementation of PopGS. These include differences in uptake and feasibility across different clinical settings as well as an absence of the efficient workflows for consent, sample collection and processing, return of results, referral and follow-up. In this proposal, we bring together experts across multiple disciplines including clinical genetics and genomics, community engagement, biomedical informatics, population health and implementation science to pilot a PopGS screening program through our Yale Clinical Group for Population Genomic Screening (YCG-PopGS). The overarching aim of our proposal is to collaborate with the Network to understand the factors that shape the adoption of PopGS in primary care in individuals unselected for any disease and to identify tools and other resources that facilitate, when appropriate, implementation of genomic screening into primary care. To that end, we will enroll and follow for a minimum of 24 months 5000 patients from across four distinct clinical settings: academic health system, private practice, a community-based hospital and community health centers, including two Federally Qualified Health Centers and a primary care center for formerly incarcerated individuals. We will screen for CDC Tier 1 conditions and select Tier 2 “near ready” conditions that our team members has significant expertise and strengths for management of these conditions. These activities will be supported by our NIH CTSA Yale Center for Clinical Investigation and proven track record in clinical trials enrollment, including PopGS studies. We will implement highly efficient workflows enabled by our industry-leading Epic EHR capabilities, which are shared across all clinical sites, led by our expert medical informatics team. Our Yale Center for Outcomes Research is ideally positioned to evaluate outcomes associated with PopGS. Using both quantitative and qualitative data derived from the EHR, patient and provider surveys and semi-structured interviews, we will employ a mixed-methods approach guided by the RE-AIM and CFIR frameworks to evaluate the implementation processes and outcomes of PopGS workflows across various primary care settings. We will work closely with other CGs and the DCC on these analyses, pooling data where appropriate for increased statistical power. Taken together, the YCG-PopGS in collaboration with the Network will generate evidence-based actionable insights and best-practices, uncovering commonalities and differences in barriers across various clinical settings. The findings will inform scalable PopGS workflows tailored to various clinical and operational contexts.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $940,555 )
2026	2026	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Human Genome Research	000	1	6/23/2026	NEW	$940,555
														Subtotal = $940,555

Grand Total All Awards = $940,555

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The Yale Population Genomic Screening Pilot: Outcomes and Best Practices for Implementation Across Different Clinical Settings.

Award Number: U01HG014624

ORGANIZATION: NATIONAL HUMAN GENOME RESEARCH INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 06/18/2026

PERIOD OF PERFORMANCE END DATE: 03/31/2031

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