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A -- Recovery After an Initial Schizophrenic Episode (RAISE)

Solicitation Number: NIMH-08-DS-0009
Agency: Department of Health and Human Services
Office: National Institutes of Health
Location: National Institute on Mental Health
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NIMH-08-DS-0009
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Solicitation
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Added: March 21, 2008
Recovery After an Initial Schizophrenic Episode (RAISE)

INTRODUCTION



This SOURCES SOUGHT NOTICE is to determine the availability of potential small businesses (e.g., 8(a), service-disabled veteran owned small business, HUBZone small business, small disadvantaged business, veteran-owned small business, and women-owned small business) for a project entitled, Recovery After an Initial Schizophrenic Episode (RAISE).



The Recovery After an Initial Schizophrenic Episode (RAISE) initiative 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 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 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/revenue).



The information from this market research will help DSIR/NIMH plan their acquisition strategy. Please be sure to indicate if you have a GSA schedule contract, a contract on GSA 8(a) STARS, or a contract on GSA VETS GWAC.



THIS IS STRICTLY MARKET RESEARCH. DSIR/NIMH WILL NOT ENTERTAIN QUESTIONS REGARDING THIS MARKET RESEARCH.



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.



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, NIMH requires offerors to 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. NIMH does not require applicants to possess established relationships with relevant Federal-level partners at the time the proposal is submitted. 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). Once an award is made, the offeror should expect to work closely with NIMH to establish active partnerships with one or more policy-making Federal stakeholders whose missions intersect with the care of persons with schizophrenia.



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.



RESPONSE INFORMATION



In order to respond to this notice, potential sources should briefly discuss their experience and/or ability to perform each of the six (6) items below:



NIMH anticipates that collaboration between multiple scientific investigators and organizations will be required. The specific experience and capabilities 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 capability 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 capability to develop appropriate outcome measures and control conditions;

5) The capability 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.



Each response should include the following Business Information:



a. DUNS.



b. Company Name.



c. Company Address.



d. Current GSA Schedules appropriate to this Sources Sought.



e. Do you have a Government approved accounting system? If so, please identify the agency that approved the system.



f. Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the Central Contractor Registration (CCR). All offerors must register on the CCR located at http://www.ccr.gov/index.asp



g. Company Point of Contact, Phone and Email address



Teaming Arrangements: All teaming arrangements should also include the above-cited information and certifications for each entity on the proposed team. Teaming arrangements are encouraged.



Responses must be submitted not later than April 11, 2008. Capability statements will not be returned and will not be accepted after the due date. The maximum number of pages for submission is 10-15 pages.



GENERAL INFORMATION



This Sources Sought Notice is for information and planning purposes only and should not be construed as a commitment by the Government. This is not a solicitation announcement for proposals and no contract will be awarded from this Notice. No reimbursement will be made for any costs associated with providing information in response to this Notice. Respondents will not be notified of the results of this evaluation. Capability statements will not be returned and will not be accepted after the due date.



As previously stated, the Government will not entertain questions regarding this Market Research; however, general questions may be forwarded to the following:



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

Please consult the list of document viewers if you cannot open a file.

Pre Solicitation Notice

Type:
Other (Draft RFPs/RFIs, Responses to Questions, etc..)
Label:
Pre Solicitation Notice
Posted Date:
May 14, 2008
Description: Recovery After an Initial Schizophrenic Episode (RAISE) - NIMH-08-DS-0009

Solicitation 1

Type:
Solicitation
Posted Date:
June 12, 2008
Description: Proposal Intent Form
Description: Proposal Submission Instructions
toc.pdf (316.71 Kb)
Description: Solicitation - NIMH-08-DS-00009
SOW.doc (189.00 Kb)
Description: Statement of Work

NIMH-08-DS-00009

Type:
Other (Draft RFPs/RFIs, Responses to Questions, etc..)
Label:
NIMH-08-DS-00009
Posted Date:
June 26, 2008
Description: Response to Questions - Solicitation

Amendment 1

Type:
Mod/Amendment
Posted Date:
July 16, 2008
Description: Response to Questions

NIMH-08-DS-00009

Type:
Other (Draft RFPs/RFIs, Responses to Questions, etc..)
Label:
NIMH-08-DS-00009
Posted Date:
July 21, 2008
Description: Responses to Questions submitted for the July 17th cut off.

NIMH-08-DS-00009

Type:
Other (Draft RFPs/RFIs, Responses to Questions, etc..)
Label:
NIMH-08-DS-00009
Posted Date:
July 29, 2008
Description: Response to Question submitted on July 28, 2008.
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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
:
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
:
Suzanne R Stinson,
Contracting Officer
Phone: 301-443-4116
Fax: 301-443-0501
:
Bruce EE Anderson,
Contracting Officer
Phone: 301-443-2234
Fax: 301-443-0501