Notice Number: NOT-MH-09-012
Key Dates
Release Date: June 23, 2009
Response Date: July 31, 2009
Issued by
National Institute of Mental Health (NIMH) (www.nimh.nih.gov)
The National Institute of Mental Health (NIMH) is seeking input on the capacity of the field to use existing healthcare networks to conduct large-scale effectiveness research of mental health treatment, preventive, and services interventions. Advice is sought from the interventions and services research communities, stakeholders within healthcare delivery systems and other interested groups on the current capacity of the field with regards to efficient use of existing user friendly health information systems for the identification, recruitment and enrollment of patients into trials; efficient recruitment of providers to deliver novel interventions within research studies; efficient collection and storage of biologic materials for research use, and in general efficient clinical data collection for research analysis.
Background
The cost of conducting large-scale effectiveness trials of treatment, preventive and services interventions to answer important mental health research questions is prohibitive. The trial enterprise, which requires identification of subjects, multiple strategies for recruitment, enrollment, randomization, data collection, and ongoing monitoring, limits the number of studies that can be launched anew within fixed research budgets. In general, effectiveness trials rarely take advantage of potential efficiencies within large-scale research and practice networks, such as electronic methods for identifying suitable participants, contacting clinicians, and collecting predictor and outcome data.
For purposes of this RFI, we define effectiveness studies as clinical trials of treatments of proven efficacy, conducted with a broadly-inclusive sample with few exclusion criteria, in real-world settings (primary as well as specialty care, nonmedical facilities such as workplaces and schools). Subjects in effectiveness trials, reflecting the actual users in the community of the treatments under study, often present with co-occurring mental or physical disorders, for which medications or other interventions outside the research protocol are being utilized; these individuals may be given a role in treatment decision-making in effectiveness research, as in clinical practice. Recent examples of NIMH-supported effectiveness studies include STAR*D (http://www.nimh.nih.gov/health/trials/practical/stard/index.shtm), STEP-BD (http://www.nimh.nih.gov/health/trials/practical/step-bd/index.shtml), and CATIE (http://www.nimh.nih.gov/health/trials/practical/catie/index.shtml).
With significant efforts needed to determine the relative effectiveness of beneficial treatments and their capacity for widespread implementation, studies will require large samples of patients, an abundance of practicing clinicians, integrated data systems to identify, assess, monitor, and follow-up patients, and capacity to conduct trials with rapidity, efficiency, safety and quality. The NIMH is interested in the development of a research platform to conduct a series of comparative effectiveness trials at costs below a traditional effectiveness trial.
Such a platform would directly respond to several objectives within the NIMH Strategic Plan (http://www.nimh.nih.gov/about/strategic-planning-reports/index.shtml), namely Objectives 3 Develop new and better interventions that incorporate the diverse needs and circumstances of people with mental illnesses and 4 Strengthen the public health impact of NIMH-supported research.
For these reasons, NIMH seeks the perspective of its multiple stakeholders to understand if and how existing healthcare delivery systems can be utilized to conduct effectiveness research, for example supporting research networks where effectiveness research can be conducted, or being available as a resource for identifying potential research participants for clinical trials. NIMH research is improved when it is informed by broad scientific and public input. In keeping with a major theme in the NIMH’s National Advisory Mental Health Council (NAMHC) Council Workgroup Report: The Road Ahead: Research Partnerships to Transform Services http://www.nimh.nih.gov/council/advis.cfm .NIMH seeks the perspective of its multiple stakeholders to ensure that the right questions are being addressed.
Request for Information
The NIMH solicits input from any and all organizations and individuals interested in treatment, prevention, and services effectiveness research in healthcare delivery systems. Specifically, information on the following topics is sought with regard to their potential to improve the efficiency of effectiveness research.
- Describe existing, linked healthcare delivery systems that are candidates to conduct large-scale research on the effectiveness of treatment, preventive, and services interventions.
- Identify what are the most efficient methods of identifying, recruiting, and consenting patients and providers for inclusion in effectiveness studies.
- Indicate whether existing health information systems can be used to collect data within effectiveness trials.
- Indicate whether capacity exists within healthcare delivery systems to collect and store biologic materials for research purposes.
- Identify what effectiveness and services research questions are most relevant to healthcare delivery systems.
Responses should be no more than 1000 words in length and should:
- specify which question is being addressed (1, 2, 3, and/or 4 above);
- explain the source of information (scientific citations; public records; individual research projects; private/ insurer data bases); and
- refine the specific research question to be addressed (either from those listed above or those relevant but not described here). If possible, outline suggested protocol components, e.g., relevant treatment and comparison conditions, estimated sample size and time scale.
Responses
This request for information is for planning purposes only and shall not be construed as a solicitation for applications or as an obligation on the part of the government. The government will not pay for the preparation of any information submitted or for the government’s use of that information.
Responses will be accepted through Friday July 31, 2009. Electronic responses are preferred and may be addressed to [email protected] (Please include the Notice number NOT-MH-09-012 in the subject line). Responses may also be sent by letter or FAX to the following address:
NIMH Healthcare Network
Division of Services and Intervention Research
6001 Executive Boulevard, Room 7133, MSC 9629
Rockville, MD 20852-9631
FAX: (301) 443-4045
Receipt of responses will be acknowledged. No basis for claims against the government shall arise as a result of response to this request for information, or in the government’s use of such information, either as part of our evaluation process or in developing specifications for any subsequent announcement. The general content of responses may be shared anonymously within the NIMH.
and Human Services (HHS)
