Notice of Intent to Publish a Funding Opportunity Announcement for Testing of Multi-Level Interventions to Improve Blood Pressure Control in Racial/Ethnic Minority, Low Socioeconomic Status, and/or Rural Populations (UH2/UH3)
Notice Number:
NOT-HL-14-238
Key Dates
Release Date: September 25, 2014
Estimated Publication Date of Announcement: November 2014
First Estimated Application Due Date: January 2015
Earliest Estimated Award Date: September 2015
Earliest Estimated Start Date: September 2015
Related Announcements
None
Issued by
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Neurological Disorders and Stroke (NINDS)
Patient-Centered Outcomes Research Institute (PCORI)
Purpose
The NHLBI, NINDS, and other NIH Institutes and Centers (ICs) intend to publish a Funding Opportunity Announcement (FOA) to solicit applications to fund up to two new patient-centered comparative effectiveness clinical trials. This initiative is supported by the Hypertension Disparities Reduction Program Partnership, a research partnership between NHLBI, NINDS, and the Patient-Centered Outcomes Research Institute (PCORI), with funds provided by PCORI to the NIH. The purpose of this new FOA is to compare alternative, evidence-based approaches to reduce inadequate control of hypertension among high risk populations, including racial/ethnic minority groups, patients with low socioeconomic status (SES), and individuals residing in rural geographical areas with an above average lifetime risk of CVD. For the purposes of this FOA, high risk populations are those with an elevated risk of fatal and non-fatal cardiovascular disease outcomes and for whom it has been challenging to achieve a high rate (> 75%) of blood pressure control.
This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.
The FOA is expected to be published in November 2014 with an estimated application due date in January 2015.
This FOA intends to utilize the UH2/UH3 activity code. Details of the planned FOA are provided below.
Research Initiative Details
The intended FOA will support randomized trials that will target populations with health disparities and those treated in health care facilities with a high rate of uncontrolled hypertension. Many high risk populations are served in health care facilities such as Federally Qualified Health Centers (FQHCs), and community clinics. Many of these populations include a significant proportion of patients insured through Medicaid. Planning, implementation, recruitment, retention, and dissemination, and other aspects of the trials will involve patients and key stakeholders in meaningful ways to assure the trial success.
The trial will have at least one active intervention arm and one or more well-defined comparator arms or groups. One comparator arm should be individuals receiving current standard of care in the health care system(s). The applicant should describe in detail the specific components of the intervention(s) in each arm of the trial and monitor implementation of these components during the course of the trial.
Active intervention arm(s) should comprise multi-level and multi-component interventions that include involvement of leadership of the health care system, practitioners, patients with hypertension, and appropriate community-based organizations. In addition, an adaptive or other innovative trial designs may be used such that changes in the intervention may occur if there is inadequate improvement in blood pressure control among specific groups or with specific intervention components.
Components of active interventions should be based on evidence and lessons from previous trials; able to engage patients and families; feasible for broad future implementation; and address system/facility, community, clinician, and patient barriers. Specified components of active interventions should address major obstacles that are more common among high risk populations.
Intervention arm components should be tailored to patient factors that increase adherence and engagement such as context, preferences, and language. Innovative interventions, such as combining changes in care team structure or function with innovative uses of technology may be included. A stepped approach should be used so that patients who remain uncontrolled will receive additional interventions that are flexible and tailored to the individual. Different components of the multi-component intervention may be directed at different levels such as the leadership of the health care system, providers, patients, and appropriate community groups or resources. Applicants are encouraged to determine whether there are specific subgroups for which specific components of the intervention are ineffective for controlling hypertension.
Applicants must carefully justify the type of trial design selected. The research design should be appropriately patient-centered, engage providers, and integrate community based resources to address patient or family barriers. Cluster randomized designs can be used to address such research questions. Randomization at the individual patient level may also be considered, if feasible. As noted above, adaptive trial designs may be considered for addressing inadequate response to the active intervention or its components, especially among population subgroups. Trial designs may be restricted to participants with uncontrolled blood pressure.
The clinical settings involved in the trial may consist solely of primary care settings or may include a majority of primary care settings with some additional selected specialty care settings, such as neurology, cardiology, endocrinology, or nephrology clinics as appropriate. The trial may recruit participants from the primary and/or specialty clinical sites and from other participating community organizations (i.e., recruiting patients who are not current patients in the trial clinical sites is acceptable).
The primary outcome of the trial is the improvement in blood pressure control between the beginning of intervention and the end of the follow-up period. The minimum duration of the follow-up period is one year. However, longer follow-up periods are desirable. One of the trial goals is to achieve a control rate of 75% or greater by the end of the trial for the group in the active intervention arm(s).
Comparing changes in the distribution of blood pressure control rates between the arms of the trial, and across subgroups within each arm, at the end of the follow-up period are important secondary outcome measures. In addition to assessing improvements in blood pressure control rates, the trial will assess important patient-centered outcomes, intervention acceptability, feasibility, fidelity, and sustainability metrics, and clinical outcomes that have a recognized impact on quality of life such as potential adverse effects of anti-hypertensive treatment, including injurious falls and episodes of renal dysfunction.
Although each funded trial will likely be conducted by a different research team and specific elements of the interventions may be different. Each study team will be responsible for the analysis of their trial data. The health facilities/systems targeted shall have extensive experience with these populations including patients, families, health systems, and the community. The investigative team must also have substantial experience conducting randomized trials and extensive research experience with the proposed health disparities populations.
To avoid duplication, encourage innovation, and enhance utility of future research findings, applications must propose patient-centered, comparative effectiveness research that specifically targets disparities in hypertension. The proposed trials must be innovative and different from previous and ongoing research by the proposing research team and past trials by other investigators. Applications will be required to address this issue. They must be distinct from the recent Agency for Healthcare Research and Quality (AHRQ) FOA on the dissemination and implementation of patient-centered outcomes research (PCOR), RFA-HS-14-008 "Accelerating the Dissemination and Implementation of PCOR findings into Primary Care Practice". Applications will not be considered responsive if they duplicate the goal of the AHRQ FOA.
Funding Mechanism
The FOA intends to use the UH2/UH3 cooperative agreement mechanism. The initial one-year UH2 phase will support the completion of milestones, and refinement and finalization of the study protocol and manual. During the UH2 phase the grantee will be required to demonstrate that most of the clinical settings in their system have functional electronic health records (EHRs) that can be used to identify individuals in these practices who have hypertension and clinical blood pressure measurements at individual and system levels. During the UH2 phase of the research, the applicants will be required to demonstrate that the proposed final study protocol is innovative and distinctive from the AHRQ funded projects. During the UH2 phase each research team will work collaboratively with NIH and PCORI to develop a protocol with key common elements. UH3 awards will be made after administrative review of UH2 accomplishments, including the final study protocol, and the determination the trial can be successfully completed in the UH3 phase.
APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.
Inquiries
Please direct all inquiries to:
Lawrence J. Fine, MD DrPH
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0305
Email: finel@nhlbi.nih.gov
Salina Waddy, MD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9135
Email: waddysp@mail.nih.gov
and Human Services (HHS)
