NIH Pragmatic Trials Conducted in Health Care Systems

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.