Pre Solicitation notice NIMH-08-DS-0009.doc

Solicitation Number: NIMH-08-DS-0009

Recovery After an Initial Schizophrenic Episode (RAISE)

The National Institute of Mental Health (NIMH) proposes to issue a Request for Proposals (RFP) NIMH-08-DS-0009 entitled, Recovery After an Initial Schizophrenic Episode (RAISE).

The objective of the resultant contract seeks to fundamentally change the trajectory and prognosis of schizophrenia through coordinated and aggressive treatment in the earliest stages of illness. The specific aims of this initiative are:

1. To develop a comprehensive and integrated treatment intervention that can be delivered in real world practice settings to promote symptomatic recovery, minimize disability, and maximize social, academic, and vocational functioning;

2. To test its feasibility and practical implementation in the community; and

3. To assess its overall clinical impact and cost-effectiveness as compared to currently prevailing treatment approaches.

The offeror must present a well-developed conceptual model of the early post-psychosis stage of schizophrenia and describe a coordinated treatment approach that addresses the unique characteristics and needs of newly ill individuals. NIMH envisions three phases to the project:

(1) a period for refining the proposed intervention based on iterative feedback from a small number of clinicians and patients; (2) a feasibility study to demonstrate that the intervention can be fielded in real world community treatment settings; and, (3) the implementation of a practical Phase III clinical trial built around the typical patients, clinicians, and payment mechanisms encountered in routine clinical practice.

NIMH envisions an 8-year timeframe to progress from the intervention refinement phase to completion of the practical clinical trial. (Note: the applicable NAICS code for this requirement is 541712, 500 employees).

BACKGROUND

The first episode of psychosis represents a critical event in the course of schizophrenia, and a unique opportunity for intervention. The best, perhaps only chance for altering the discouraging prognosis commonly associated with schizophrenia is to intervene aggressively at the first episode of psychosis, before functional abilities are lost. The RAISE initiative will test this hypothesis by supporting the development, deployment, and testing of an early intervention model for schizophrenia that is relevant to the U.S. mental health system in the sense that, if found to be effective in real world settings and relatively cost-effective, it could be deployed feasibly at a population level.

RAISE is innovative in two respects. First, RAISE will shift the focus of schizophrenia treatment away from managing end stage disease to early and aggressive treatment. The goal here is indicated prevention that pre-empts symptomatic and functional deterioration in the early years of illness. We hypothesize that effective early intervention may shift the long-term trajectory of illness away from chronic disability towards more normal functioning. Second, RAISE represents a coordinated effort to design and test an intervention for early phase schizophrenia that should be feasible to implement on a wide, i.e., population-level, scale. From the earliest stages of development, this intervention will incorporate necessary features for rapid dissemination, adoption, and implementation in our communities, thus facilitating the transition from research to practice. The ultimate goal is to transform the current paradigm for treating schizophrenia in the United States by engineering rapid adoption and implementation of an effective treatment package on a broad scale.

From a scientific perspective, the RAISE initiative seeks to explore whether the early course of schizophrenia can be altered, from the first psychotic episode forward. However, when a patient first presents with psychotic symptoms, it is often unclear which DSM-IV diagnosis is most appropriate. Depending on the characteristics and duration of symptoms at the time of presentation, a variety of diagnoses are possible, including brief reactive psychosis, schizophreniform disorder, schizophrenia, schizoaffective disorder, and either bipolar disorder or major depression with psychotic features. Diagnostic uncertainty for newly ill individuals is encountered frequently in real world treatment settings, and it is unrealistic to expect that clinicians will withhold treatment until a definitive diagnosis is established. Consequently, NIMH requires that the scope of RAISE include all persons experiencing a first episode of psychosis that could plausibly lead to a diagnosis of schizophrenia.

To accomplish the goals outlined above, NIMH advocates a clinic-based, deployment-focused treatment development process. As its name implies, the clinic-based, deployment-focused model anticipates the clinical, economic, and logistical characteristics of the settings where an intervention will be delivered during development and pilot-testing, as well as the settings where it will ultimately be implemented in the real world. The model encourages collaboration among scientific content experts, services researchers, and end users to anticipate clinical and practical circumstances that can impede adoption and implementation of an effective intervention in community settings. These features include characteristics of typical patients, clinicians already available in target settings, training and supervision requirements necessary to introduce new approaches, space, time, and material resource constraints, and likely payment mechanisms for the new intervention. By attending to these issues early on it is more likely that health care providers, administrators, payers, and policy makers will be able and willing to adopt and implement any intervention(s) developed and tested in RAISE.

To maximize the chances for developing and testing a clinically relevant and transportable intervention for first episode schizophrenia, offerors should demonstrate working relationships with relevant stakeholder groups at the time the proposal is submitted. Examples of relevant stakeholders include members of consumer and advocacy organizations, representatives of real world delivery systems that regularly encounter individuals in the earliest phase of schizophrenia, and purchasers of health care and disability benefits at state and local levels. After award, the contractor will be expected to work closely with NIMH to establish close working relationships/partnerships with one or more relevant Federal-level partners, whose missions intersect with the care of persons with schizophrenia. Examples of relevant Federal-level partners include the Substance Abuse and Mental Health Services Administration (SAMHSA), the Centers for Medicare and Medicaid Services (CMS), the Social Security Administration (SSA), the Health Resources and Services Administration (HRSA), and the Department of Justice (DoJ).

NIMH anticipates that collaboration between multiple scientific investigators and organizations will be essential. The specific experience and expertise necessary to perform this work include (but are not limited to):

1) Experience in performing large scale effectiveness trials in schizophrenia, and randomized clinical trials in first episode patients, specifically;

2) Ability to recruit significant numbers of subjects experiencing an initial psychotic episode from multiple representative community sites, and ability to retain and follow up subjects in an ongoing clinical trial

3) The ability to develop a comprehensive and integrated treatment model involving pharmacological, psychosocial, rehabilitative, and therapeutic case management interventions to promote long term recovery and forestall loss of function in people in a first psychotic episode;

4) The ability to develop appropriate outcome measures and control conditions;

5) The ability to provide scientific oversight, facilitate collaboration among the investigators, integrate complex protocol management, data acquisition, bio-statistical data analysis and reporting of results from clinical trials involving subjects with schizophrenia.

6) Experience collaborating with multiple experts and stakeholders (investigators, clinicians, policy makers, advocates, and consumers) in schizophrenia research.

The NIMH plans to award a contract by December 15, 2008 or earlier. RFP No. NIMH-08-DS-0009 will be available on or about May 29, 2008 and the receipt date of proposals on or about July 29, 2008. The RFP may be accessed through http://www.fedbizopps.gov. It will be the offeror’s responsibility to monitor the FedBizOpps web page for release of the solicitation, and any possible subsequent amendments, and to download the documents and all attachments. Please note that the RFP for this requirement will include the Statement of Work, Deliverables, and Reporting Requirements, the Technical Evaluation Criteria, and proposal preparation instructions. All information required for the submission of an offer will be contained in the electronic RFP package. All responsible sources are encouraged to submit a proposal that will be considered by the NIMH. This advertisement does not commit the Government to award a contract.

Please contact Suzanne Stinson, Contracting Officer (preferably via e-mail) at sstinson@mail.nih.gov for further information.

Contracting Officer:

Suzanne Stinson 6001 Executive Boulevard, Room 8154, MSC 9661 Bethesda, MD 20892-9661 Phone: 301-443-4116 Fax: 301-443-0501 Email: sstinson@mail.nih.gov

Contracting Office Address:

Department of Health and Human Services, National Institutes of Health, National Institute on Mental Health, Contracts Management Branch 6001 Executive Blvd, Rm 8154, MSC 9661, Bethesda, MD, 20892-9661, UNITED STATES

Place of Performance:

Contracting Officer:Suzanne Stinson 6001 Executive Boulevard, Room 8154, MSC 9661 Bethesda, MD Phone: 301-443-4116 Fax: 301-443-0501 Email: sstinson@mail.nih.gov 20892-9661

Primary Point of Contact.:

Suzanne R Stinson, Contracting Officer ss704b@nih.gov Phone: 301-443-4116

Fax: 301-443-0501

Secondary Point of Contact:

Bruce E. Anderson, Contracting Officer ba9i@nih.gov Phone: 301-443-2234

Fax: 301-443-0501

Point of Contact(s):

Suzanne Stinson, Contracting Officer, Phone 301-443-4116, Fax 301-443-0501, Email ss704b@nih.gov - Bruce Anderson, Contracting Officer, Phone 301-443-2234, Fax 301-443-0501, Email ba9i@nih.gov