NIH Pragmatic Trials Conducted in Health Care Systems
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Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.
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The National Institutes of Health plans to issue a Notice of Funding Opportunity focused on funding large-scale pragmatic and implementation trials conducted within health care settings. These trials aim to evaluate the effectiveness of biomedical or behavioral interventions as they are applied in routine clinical care, and to assess strategies for implementing these interventions within various health care environments. The goal is to generate evidence that is highly relevant and useful to decision-makers such as patients, clinicians, administrators, policymakers, and payers by comparing the benefits, burdens, and risks of the interventions in real-world settings. Applicants are encouraged to design studies that take place in care settings where the target conditions frequently occur, such as emergency departments or primary care clinics, and to include multiple types of health systems to enhance the generalizability of results. The interventions should be integrated into routine care and may involve either proven treatments or system-level modifications intended to improve patient outcomes. The funding mechanism will be a phased, milestone-driven cooperative agreement, supporting a planning phase followed by full trial execution. Although applications are not currently being accepted, this advance notice provides time for potential applicants to form collaborations and prepare strong proposals. The opportunity is overseen by the NIH's National Center for Complementary and Integrative Health Extramural Research Program.
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The National Institutes of Health intends to publish a Notice of Funding Opportunity (NOFO), Pragmatic and Implementation Trials Conducted in Health Care Settings
This funding opportunity will support large-scale pragmatic trials that test intervention effectiveness in routine clinical care and/or implementation trials that evaluate strategies for delivering interventions within health care settings. These trials are intended to directly inform decision-makers (e.g., patients, clinicians, administrators, policymakers, and payers) about the comparative benefits, burdens, and risks of biomedical or behavioral interventions.
To enhance real-world relevance and generalizability, applicants are encouraged to:
1) Select care settings where the target condition is commonly seen (e.g., emergency departments, primary care, public health clinics).
2) Include multiple health system types (e.g., academic centers, federally qualified health centers, integrated networks, VA Medical Centers).
3) Assess adaptation across systems and regions to ensure intervention effectiveness and implementation feasibility.
Interventions under study should be embedded in routine care. Trials may integrate one or more interventions with established efficacy into appropriate health care settings or implement system-level changes to improve health outcomes.
This phased award will use a milestone-driven cooperative agreement mechanism, supporting a planning phase and a phase for full trial execution.
Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. Investigators with expertise and insights into this area are encouraged to begin to consider applying for this NOFO.