AHRQ ARRA RFA on Complex Patients

Recovery Act 2009 Limited Competition OS ARRA: Comparative Effectiveness Research to Optimize Prevention and Healthcare Management for the Complex Patient (R21)

Letters of Intent Receipt Date: January 8, 2010
Application Due Date: January 20, 2010

Research Plan component of the application may not exceed 15 pages

12-18 awards anticipated – AHRQ will fund three types of projects:

Epidemiologic descriptions based on secondary analysis of large data sets of specific chronic illnesses for which there are no recently assembled data which describe the natural history, impact on quality of life over time, and life expectancy. In addition to describing the natural course of the disease, applications must describe the cumulative burden of therapies for the conditions over time, such as the number and types of medications, other recommended treatments, and services for tertiary prevention. Applications should describe at least 2 chronic illnesses, and applications will be greatly strengthened if they include descriptions of the epidemiology of the conditions for individuals, both with and without co-morbid chronic conditions. At least one of the chronic conditions must be one of the priority conditions identified above. Applications must clearly document either the lack of published information describing the epidemiology of the condition, or the need to update information due to developments in treatment that have altered the condition’s epidemiology. AHRQ expects a focus on priority population groups, including racial and ethnic minority populations. Studies that focus on this type of secondary data analysis are expected to be proposed with project period total cost budgets in the range of $250K to $375K and take 12-18 months to complete. Applications in this category that exceed $375,000, or 18 months, will not undergo peer review.

Analytic epidemiologic studies, e.g., using a retrospective cohort design, that assess the benefits and harms of preventive or therapeutic interventions in “real world” settings for patients who have multiple chronic co-morbid conditions. These studies would need to use cohorts with sufficient clinical data, and to use innovative statistical techniques in order to determine the relative positive and negative impacts of prevention/therapy in a population with comorbid illness compared to an otherwise healthy population. Studies of this type are expected to have project period total costs in the range of $400K to $500K, and take up to 2 years to complete.

Modeling studies that use accepted techniques to project the impact of recommended chronic disease interventions and preventive services on patients with two or more co-morbid chronic conditions. Both decision models and cost-effectiveness analysis models are acceptable. Expected findings would be expressed in terms of life years gained, quality adjusted life years, or costs per quality adjusted life years. Studies of this type must describe the chronic conditions of interest, treatment guidelines that will be utilized for selecting therapeutic interventions to be modeled, and preventive service(s) to be modeled. At least one of the chronic conditions to be modeled must be one of the priority conditions identified above. The use of nationally-recognized and evidence-based guidelines and preventive service recommendations such as those of the U.S. Preventive Services Task Force are encouraged wherever possible within projects. Models used in these studies should be sufficiently comprehensive to model the impact of the co-morbid condition on issues of competing morbidity and/or mortality, and on benefits and harms of the intervention if appropriate. Modeling projects may use existing data sets or propose conducting an epidemiologic study as foundational to the model. Modeling projects are expected to be proposed with budgets for the project period in the $300K to $500K total costs range and may take between 1.5-2 years.

The objectives of this FOA are to:

-Support comparative effectiveness research to allow prioritization of evidence-based services (testing and treatment) for patients with multiple co-morbidities (including physical and mental conditions), and suggest appropriate adaptations (in timing and frequency) of recommended preventive and care management guidelines for these patients.

-Provide evidence to clarify how co-existing chronic conditions modify the safety or comparative value of proven treatments for chronic diseases and recommended preventive interventions.

-Provide evidence to refine chronic disease quality measures for complex and frail patients.

To achieve these objectives, expected research approaches include mathematical modeling, statistical modeling, or epidemiologic studies that may be based on data from population surveys, medical databases from electronic health records, and possibly insurance claims data. Of interest are modeling projects that use newly developed or existing population-based datasets to estimate how the application and timing of specific, recommended therapeutic and preventive services will affect overall outcomes for the complex patient, especially as the patient ages. Modeling studies must consider how to optimize the management of patients with at least 2 chronic co-morbid conditions and the provision of at least one preventive service or chronic disease intervention. Studies focusing on AHRQ priority populations, including racial and ethnic groups, are encouraged (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html). All types of studies are welcome to include a mental health co-morbidity.

Mary Barton, MD, MPP
Center for Primary Care, Prevention & Clinical Partnerships, AHRQ
Telephone: (301) 427-1638
Mary.Barton@ahrq.hhs.gov

Therese Miller, DrPH
Center for Primary Care, Prevention & Clinical Partnerships, AHRQ
Telephone: (301) 427-1585
Therese.Miller@ahrq.hhs.gov

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