Deadline: 31-May-23
The Patient-Centered Outcomes Research Institute (PCORI) is 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.
Through this PFA, PCORI seeks to fund rigorous, high-quality randomized controlled trials (RCTs) that compare health system strategies to improve blood pressure management and control in primary care, community, and safety net settings for populations experiencing disparities in outcomes (e.g., Black, Hispanic, rural, and/or uninsured individuals). This targeted funding announcement encourages multisite cluster RCTs with mixed methods design or robust process evaluation to support the possibility of widespread implementation.
Funding Information
- Up to $10 million (smaller studies) and up to $15 million (large, multi-site trials)
- Maximum Project Period: Up to 5 years
Specific Requirements for this Funding Announcement
- PCORI seeks to fund rigorous, high-quality, and impactful clinical studies that address the following research 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).
Outcomes
- Applications should propose well-justified outcomes that are clinically meaningful and considered important by patients and/or their caregivers and on which impact by proposed interventions can be assessed during the duration of the study.
- Blood pressure (e.g., change in average systolic blood pressure or the ability to control blood pressure) at or after 12 months from initiation of intervention must be included as a primary outcome.
- Applicants are also strongly encouraged to include well-validated outcome measures in the following areas: clinical, utilization, quality of care, health-related quality of life or ability to reach personal health goals, healthcare patient activation, care satisfaction and experience (including experience of racism, discrimination, and bias), and social determinants of health. For information on cost-related outcomes, please review Principles for Consideration of Full Range of Outcomes Data in PCORI Funded Research.
Eligibility Criteria
- In general, applications for the conduct of research and management of funding may be submitted by appropriate academic research, private sector research, or study-conducting entities. This may include, among others, agencies and instrumentalities of the Federal Government, nonprofit and for-profit research organizations, and colleges and universities.
- Per PCORI’s authorizing statute, every applicant must demonstrate capability to comply with the following conditions:
- abide by the transparency and conflicts of interest requirements that apply to PCORI with respect to the research managed or conducted under contract;
- comply with the PCORI methodological standards adopted by the Board of Governors;
- consult, as appropriate, with the expert advisory panels for clinical trials and rare disease;
- deposit de-identified data from the original research into a PCORI-designated repository to facilitate data sharing, as appropriate;
- have appropriate processes in place to manage data privacy and meet ethical standards for the research;
- comply with the requirements of PCORI for making the information available to the public; and
- comply with other terms and conditions determined necessary by PCORI to carry out the research project.
- Potential applicants are strongly encouraged to review the standard research contract prior to application.
Ineligible
- Individuals are not permitted to apply.
- Foreign Organizations and Nondomestic Components of U.S. Organizations must provide a thorough and thoughtful justification for the research’s ability to benefit the US healthcare system and that the engagement plans include US patients and stakeholders, and are relevant to US healthcare system.
For more information, visit PCORI.