Recovery Act Limited Competition: Behavioral Economics for Nudging the Implementation of Comparative Effectiveness Research: Clinical Trials (RC4)
National Institute on Drug Abuse
This NIH Funding Opportunity Announcement (FOA), supported by funds provided to the NIH and AHRQ under the American Recovery & Reinvestment Act of 2009 ("Recovery Act" or "ARRA"), Public Law 111-5, invites applications proposing clinical trials using the principles of behavioral economics to enhance the uptake of the results of comparative effectiveness research (CER) among health care providers in their practice. For this FOA, applicants must propose controlled trials that randomize units (whether individuals or clusters such as practices, hospitals, or larger units) to conditions, resulting in a randomized clinical trial (RCT) or cluster randomized trial (CRT). Behavioral economics refers to the interdisciplinary efforts involving cognitive and social psychologists, decision scientists, and other social scientists together with economists to model economic decision-making and consequent actions
This initiative is one of several being offered to help fulfill the goals of the American Recovery and Reinvestment Act (ARRA) to help stimulate the economy through support of biomedical and behavioral research. Additional information the Recovery Act and related NIH opportunities is available through the Office of Extramural Research (http://grants.nih.gov/recovery/ )
Participating NIH Institutes:
This FOA invites applications proposing a large-scale clinical trial whose primary outcome would be to determine whether a specific approach to changing provider behavior based on the principles of behavioral economics could enhance the uptake of the results of comparative effectiveness research (CER) among health care providers in their practice. In addition, such trials could also be designed to examine levels of patient compliance at a brief (e.g., 6 month) interval resulting from the level of CER uptake as a secondary outcome.
For the purposes of this FOA, the definition of comparative effectiveness research will adhere to that adopted by the Federal Coordinating Council given at http://wayback.archive-it.org/3909/20130926125230/http://www.hhs.gov/recovery/index.html: "Comparative effectiveness research is the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat and monitor health conditions in "real world" settings. The purpose of this research is to improve health outcomes by developing and disseminating evidence-based information to patients, clinicians, and other decision-makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances.
- To provide this information, comparative effectiveness research must assess a comprehensive array of health-related outcomes for diverse patient populations and subgroups.
- Defined interventions compared may include medications, procedures, medical and assistive devices and technologies, diagnostic testing, behavioral change, and delivery system strategies.
- This research necessitates the development, expansion, and use of a variety of data sources and methods to assess comparative effectiveness and actively disseminate the results."
In the context of this FOA, behavioral economics refers to the interdisciplinary efforts involving cognitive and social psychologists, decision scientists, and other social scientists together with economists to model economic decision-making and consequent actions. Behavioral economics acknowledges the important role that a specific context (or frame) may have on decisions, and takes into account people's apparently irrational preferences (e.g., losses count more than gains, an object that is owned is more valuable than the same object that is not owned). For a recent review of behavioral economics from an economic perspective, Dellavigna (2009) is useful; from a psychological standpoint, Kahneman and Tversky (2000) and Kahneman (2003) provide useful data and historical context.
Priority-Setting Process and Inputs for use of ARRA OS Funds
There were four main inputs for priorities for ARRA OS CER funds: public input, an internal Departmental workgroup, the FCC report, and the IOM report. The FCC identified the following as minimum threshold criteria which must be met to be considered for funding:
- Included within statutory limits of ARRA and the Council's definition of CER;
- Potential to inform decision-making by patients, clinicians or other stakeholders;
- Responsiveness to expressed needs of patients, clinicians or other stakeholders;
- Feasibility of research topic (including time necessary for research).
The CER-CIT will require the use of the FCC's prioritization criteria for scientifically meritorious research and investments for all projects funded with OS ARRA funds. These criteria are:
- Potential impact (based on prevalence of condition, burden of disease, variability in outcomes, costs, potential for increased patient benefit or decreased harm),
- Potential to evaluate comparative effectiveness in diverse populations and patients sub-groups and engage communities in research,
- Addresses existing uncertainty within the clinical and public health communities regarding management decisions and variability in practice,
- Addresses a need or is unlikely to be addressed through other organizations,
- Potential for multiplicative effect.
Finally, investments funded from this appropriation must address at least one of the following topic areas:
- One of the 100 IOM topic recommendations or the 10 general recommendations and/or
- An issue within one the MMA 14 priority conditions identified by AHRQ which are not currently addressed;
- Fall into one of the AHRQ identified evidence gaps or be identified in the FCC report to the Congress.
The current list of priority conditions includes:
- Arthritis and nontraumatic joint disorders (Muscle, bone, and joint conditions)
- Cancer (Cancer)
- Cardiovascular disease, including stroke and hypertension (Heart and blood vessel conditions)
- Dementia, including Alzheimer's Disease (Brain and nerve conditions)
- Depression and other mental health disorders (Mental health)
- Developmental delays, attention-deficit hyperactivity disorder, and autism (Developmental delays, ADHD, autism)
- Diabetes mellitus (Diabetes)
- Functional limitations and disability (Functional limitations and physical disabilities)
- Infectious diseases including HIV/AIDS (Infectious diseases and HIV/AIDS)
- Obesity (Obesity)
- Peptic ulcer disease and dyspepsia (Digestive system conditions)
- Pregnancy including preterm birth (Pregnancy and childbirth)
- Pulmonary disease/asthma (Breathing conditions)
- Substance abuse (Alcohol and drug abuse)
Scope: This FOA solicits applications for large-scale, multi-site, 3-year projects proposing randomized clinical trials (RCTs), cluster randomized trials (CRTs), or other robust randomized trial designs from multidisciplinary teams with relevant expertise in behavioral economics, psychology, epidemiology, clinical and health services research targeting the uptake of specific, previously identified CER. (Note: this FOA does not target establishment of new CER findings, but the uptake of previously validated CER.)
The overall intent of this FOA is to provide applicants maximum freedom in the design of their proposed trial, limited only by the requirement that behavioral economic techniques be used to change provider behavior and that the uptake of validated CER results be the primary outcome.
Applicants should plan to attend an AHRQ CER conference of awardees supported under this RFA for dissemination purposes. For budgetary purposes, applicants should plan for two representatives to travel to the Washington, DC, area for conference presentations as arranged by AHRQ and NIA. To this end, applicants should present a relevant plan, to include involved personnel, budget justifications, and timetables appropriate to participating in such a conference.
In addition, applicants should plan to attend an annual investigator's meeting including grantees from this FOA and, the companion Clinical Trials FOA, and other currently funded investigators working in the areas of behavioral economics and increasing the uptake of CER
This initiative is supported by funds provided to the NIH and AHRQ under the American Recovery & Reinvestment Act of 2009 ("Recovery Act" or "ARRA"), Public Law 111-5. The NIH has designated $15,000,000 in FY(s) 2010, 2011, and 2012 to fund 2 grants, contingent upon the submission of a sufficient number of scientifically meritorious applications.
The total project period for an application submitted in response to this funding opportunity may not exceed three years. Although the size of award may vary with the scope of research proposed, applications must stay within the budgetary guidelines for this FOA; total costs are limited to $7,500,000 over a three-year period. Grants that are awarded will have to use a non-modular budget.
This program is supported by funds provided to the NIH and AHRQ under the Recovery Act. The purpose of the Recovery Act is to stimulate the American economy through job preservation and creation, infrastructure investment, energy efficiency and science, and other means. Consistent with these goals, domestic (United States) institutions/organizations planning to submit applications that include foreign components should be aware that requested funding for any foreign component should not exceed 10% of the total requested direct costs or $25,000 per year (aggregate total for a subcontract or multiple subcontracts), whichever is less.
Eligible Institutions: Consistent with the purposes of the Recovery Act (in particular, to preserve and create jobs and promote economic recovery in the United States, and to provide investments needed to increase economic efficiency by spurring technological advances in science and health), applicants must be a domestic (United States) institution/organization. Foreign organizations/institutions are not permitted as the applicant organization.
- More than one PD/PI (i.e., multiple PDs/PIs) may be designated on the application
- This is a one-time-only solicitation, resubmissions are not permitted.
- The RC4 application Research Strategy component of the PHS398 (Items 3-5) may not exceed 12 pages, including tables, graphs, figures, diagrams, and charts.
Release/Posted Date: December 28, 2009
Opening Date: March 7, 2010 (Earliest date an application may be submitted to Grants.gov)
Application Due Date(s): April 7, 2010
Peer Review Date(s): May/June 2010
Earliest Anticipated Start Date(s): August 31, 2010
Expiration Date: April 8, 2010
Applicants are requested to notify the National Institute on Aging Referral Office by email (vemuriR@nia.nih.gov) when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
Jonathan W. King, Ph.D.
Division of Behavioral and Social Research
National Institute on Aging
7201 Wisconsin Ave. #533
Bethesda, MD 20892-9205
Telephone: (301) 402-4156
Fax: (301) 402-0051
Bill Encinosa, Ph.D.
Center for Delivery, Organization and Markets
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850