Notice of Upcoming Targeted PCORI Funding Announcement

The Patient-Centered Outcomes Research Institute (PCORI) plans to reissue a Targeted PCORI Funding Announcement on May 2, 2023 (Cycle 2 2023) seeking to fund large randomized controlled trials (RCTs) comparing health system strategies to improve hypertension control and health outcomes for populations experiencing disparities in outcomes, e.g., Black, Hispanic, rural, and/or uninsured individuals. This preannouncement provides potential applicants additional time to identify collaborators; obtain patient and stakeholder input on potential studies; and develop responsive, high-quality applications.

Hypertension affects almost half of US adults, with the highest prevalence among non-Hispanic Black men and women. Despite hypertension’s treatability, most US adults with hypertension do not have their blood pressure under control, especially people of color, those without access to care or health insurance, and individuals living in rural areas. Health systems factors including the delayed identification of high-risk patients, insufficient linkage to treatment and services, and/or a failure to initiate or intensify treatment when needed may inhibit patients’ ability to control their blood pressure. Implicit bias among healthcare providers may contribute to treatment inertia; inhibit timely, appropriate care delivery; and encumber patient-provider communication, further contributing to poor health outcomes for patients.

National organizations have identified several effective health systems strategies—including practice facilitation, team-based care, health coaching, and home blood pressure monitoring—to be effective for improving rates of hypertension control when implemented as part of multicomponent, multilevel health systems strategies. Although the evidence base for these health systems strategies is robust, questions remain about the optimal health system strategies to eliminate disparities in hypertension control; strategies for the integration of and communication with community-based team members (nurse, pharmacist, community health worker); models for the provision of simplified pharmacotherapy regimens or free or low-cost medications; and the impact of remote care delivery on the initiation and intensification of treatment, patient engagement and experience, and clinical outcomes, especially in historically excluded, under-researched, and/or under-resourced populations and safety net healthcare settings.

This Targeted PCORI Funding Announcement will solicit applications that respond to the following question:

What is the comparative effectiveness of health system strategies to improve hypertension control for populations experiencing disparities in hypertension control and associated health outcomes, e.g., Black, Hispanic, rural, and/or uninsured individuals?

The reissued funding announcement will emphasize the following:

• Applicants will be asked to propose studies in adults with high blood pressure that is not controlled, especially those in underserved, underrepresented, or historically excluded populations, including Black, Hispanic, rural, and/or uninsured individuals. Studies that provide knowledge about an intervention’s impact on multiple subgroups (i.e., studies that are adequately powered for evaluating heterogeneity of treatment effects) are strongly encouraged.
• Interventions must be health system strategies, including but not limited to practice facilitation and redesign; team-based care; support for medication access and adherence (e.g., fixed-dose combinations, simplified medication regimens, 90-day prescriptions, use of mail-order pharmacies); telehealth; risk communication and shared decision making tools; community linkage, referral, or service provision; and community health workers. PCORI is especially interested in studies comparing care delivery strategies designed to address therapeutic inertia and patient-centered strategies to improve medication access and adherence.
• Applicants must propose studies with blood pressure (e.g., change in average systolic blood pressure or ability to control blood pressure) at 12 months or later from initiation of intervention as a primary outcome. Research projects are strongly encouraged to conduct periodic outcome assessments, including long-term follow-up periods at or greater than 18 months from the primary outcome (i.e., 30 months from intervention initiation).

For questions regarding this funding announcement, please reach out to [email protected].