SPECIAL NOTICE
A -- Notice of Intent to Award Sole Source Modification to The Research Foundation for Mental Hygiene (RFMH) for Recovery After an Initial Schizophrenia Episode Implementation Evaluation Study (RAISE-IES): Duration of Untreated Psychosis Study
- Notice Date
- 7/2/2013
- Notice Type
- Special Notice
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- 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, Maryland, 20892-9661
- ZIP Code
- 20892-9661
- Solicitation Number
- HHS-NIH-271-2009-000-20-C
- Archive Date
- 8/19/2013
- Point of Contact
- Marla Jacobson, Phone: 301-443-2696, Bruce E. Anderson, Phone: 301-443-2234
- E-Mail Address
-
jacobsonmj@mail.nih.gov, banderso@mail.nih.gov
(jacobsonmj@mail.nih.gov, banderso@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a notice of intent, not a request for proposals. A solicitation document will not be issued and proposals will not be requested. The National Institute on Drug Abuse (NIDA), Office of Acquisitions - Neurosciences, National Institute of Mental Health (NIMH)/National Institute on Aging (NIA) Research and Development Contracts Management Branch (R&D CMB), on behalf of the NIMH, intends to negotiate a modification to an existing contract on a sole source basis pursuant to 41 U.S.C. 253[c](1) as implemented by FAR 6.302-1, (Only one responsible source and no other services will satisfy agency requirement) with: Research Foundation for Mental Hygiene New York State Psychiatric Institute Division Riverview Center 150 Broadway, Suite 301 Menands, NY 12204 BACKGROUND Approximately 100,000 adolescents and young adults experience a first episode of psychosis (FEP) each year in the United States. Multi-element FEP specialty care treatment programs can produce a range of positive clinical and functional outcomes. The timing of treatment is critical, however; short and long-term outcomes are better when individuals begin treatment close to the onset of psychosis. Numerous studies find a substantial delay between the onset of psychotic symptoms and the initiation of treatment; in the U.S. treatment is typically delayed between one and three years, suggesting that many FEP persons are missing a critical opportunity to benefit from early intervention. "Recovery After an Initial Schizophrenia Episode" awarded on a competitive basis on 07/13/2009 to The Research Foundation for Mental Hygiene (RFMH) under Contract # HHSN271200900020C, is a cost-reimbursement research and development type contract, and expires on December 31, 2013. Under this contract, RFMH developed and is testing a multi-element FEP specialty treatment program, while concurrently conducting an implementation and evaluation study of the intervention. In the service of both of these aims, approximately 60 individuals experiencing a first episode of psychosis were enrolled in programs located at 2 clinics (in Maryland and New York City), received a minimum of one year of active treatment, and are participating in ongoing research assessments. Treatment manuals, engagement strategies, and approaches to delivering and financing the specialty care program have been developed as part of the larger implementation effort. The purpose of this contract modification is to conduct additional research assessments with existing participants and their family members in order to enhance information received, and provide detailed information on referral pathways that resulted in enrollment in the FEP specialty care programs. This additional data will be used to identify gaps and bottlenecks in referral pathways in order to inform the development and pilot testing of targeted community outreach, provider education, and patient/family engagement strategies to serve the larger goal of reducing duration of untreated psychosis among individuals experiencing a first episode of psychosis. RFMH is uniquely qualified to perform this work and the existing RAISE sample is uniquely poised to provide the most useful information in the timeliest and most cost efficient manner. Due to the existing contract, teams at both study sites have established ongoing clinical relationships with ~ 60 individuals in treatment for a first episode of psychosis who are available to participate in additional research assessments. Participants are followed for up to two years, with good retention over time. Existing IRB-approved protocols at both study sites contain provisions to allow for rapid initiation of the requested work. As these participants and their family members have already provided preliminary information about treatment history, follow-up interviews focused more specifically on pathways to care would be a natural extension of the work. The high retention rate among participants in the ongoing research assessments demonstrates that the existing research infrastructure and team would be able to engage participants for additional assessments quickly and easily. And, because the contract has not yet ended, existing research staff can be easily trained with respect to any new interview protocols. Significant Federal resources have already been devoted to establishing this research infrastructure and study. The questions to be asked will effectively enhance the work already conducted. In addition, RFMH is uniquely qualified to perform this work because of the contract PI's involvement in developing an expansion of First Episode Psychosis treatment programs in New York State for the NYS Office of Mental Health. This expansion involves the imminent initiation of new community clinics that are based on the RAISE multi-element specialty treatment program developed in the original contract to RFMH. These new programs can serve as a platform to efficiently implement and evaluate the outreach, education, and engagement strategies to be developed as part of this contract modification. There will also be research staff common to both efforts (RAISE and the NYSOMH program). The existing research infrastructure, access to patients and their families, and connection to new programs timed to overlap with the data generation from this project create a stage for research expediency that a new contractor would be unable to meet in the time needed to conduct the work. The data generated from this project will be of critical importance to, among others, clinicians, families, and policy makers. Under the requirements of 41 U.S.C. 253[c](1) and FAR 6.302-1, RFMH is the only source capable of meeting the requirements of this project and no other services will satisfy agency requirement(s). PURPOSE AND OBJECTIVES The purpose OF THIS PROPOSED ACTION is to extend the CONTRACT'S current period of performance an additional 36 months, to allow for time to: 1) Conduct additional timeline follow-back interviews with individuals already enrolled in the research study and their family members in order to enhance information already received and provide detailed information on care pathways that ultimately led to enrollment in the FEP specialty care programs ; 2) Develop new outreach, education, and engagement strategies designed to reduce duration of untreated psychosis based on an analysis of gaps and bottlenecks in existing referral pathways (i.e., data collected during the follow-back interviews); and 3) Conduct preliminary feasibility tests of the value of these strategies for reducing delays in the identification and rapid referral of FEP patients to specialty care. PROJECT REQUIREMENTS This work will be conducted in the context of a statewide implementation of first episode treatment programs. Follow-back interviews will be conducted with approximately 60 individuals who are experiencing a first episode of psychosis and are currently involved in a treatment research study. The overall objective is to collect pilot and feasibility data to inform the long term goal of reducing the duration of untreated psychosis for individuals in the United States. REPORTS/DELIVERABLES All reports shall be submitted in electronic form as PC-formatted computer files in Microsoft Word and Microsoft Excel and/or searchable PDF format. The following reports will be required: A. Semi-Annual Reports, (1) electronic copy, B. Final Progress Report one (1) electronic copy and one (1) hardcopy due on the date of contract completion. The Final Progress Report shall cover the period of performance from date of modification award through completion, and shall include an abstract and two sections. This report shall be in sufficient detail to explain comprehensively the Tasks accomplished and the results achieved, and shall summarize data and statistical analyses performed in text, tabular and graphical form. The abstract should be no more than 250 words and summarize any salient results of the work performed. Section 1 shall be a publication-ready summary of pathways to care (Aim 1) and any ‘gaps' and ‘bottlenecks' identified that may contribute to longer durations of untreated psychosis (Aim 2); Section 2shall summarize potential engagement, education, and outreach strategies to reduce duration of untreated psychosis among individuals who are eligible for treatment through newly established FEP programs. It will also include a Summary of Salient Results. The report should include the plan for a next phase research study to evaluate the effectiveness of the identified strategies (Aim 3) as well as feasibility data from the pilot implementation of new strategies; C. Final Data Set and documentation (electronic copy - CD) D. Other Reports and Deliverables: 1. NIMH DSMB Reports (three times per year); 2. Report of Government Owned, Contractor Held Property (annually and final); 3. Small Business Subcontracting Reports (twice per year); 4. Roster of Employees Requiring Suitability Investigations (updated annually and within 14 days of new contractor/subcontractor employees start date; 5. Information Security Training Report - updates with each technical progress report and within 14 days of new contractor/subcontractor employees start date; 6. Contractor-Employee Non-Disclosure Agreement - as applicable before contractor/subcontractor employee begins work; 7. NIST SP 800-53 Self-Assessment - Annually; Updated ISSP due within 30 days of modification award; 8. Section 508 Annual Report; 9. Annual and Final Invention Disclosure Reports; 10. Required Education - Protection of Human Research Participants (as applicable); ANTICIPATED PERIOD OF PERFORMANCE The anticipated period of performance is 8/31/2013 - 9/01/2016 (36 months). OTHER IMPORTANT CONSIDERATIONS The Contractor is involved in a statewide expansion of FEP treatment programs in New York, enabling ready access to at least three new FEP multi-component treatment program sites in 2013. These new FEP program sites may be used as settings to pilot newly developed engagement, education and outreach strategies. The Government will not support the development of new FEP multi-element treatment programs as part of this requirement. In order to expedite research progress, potential sources must demonstrate established access to multi-element FEP treatment programs. Multi-element FEP treatment is defined as a program of care that offers stage-specific pharmacotherapy, recovery-oriented psychotherapy, case management, family psycho-education, and supported employment/education within a team-based approach to treatment. A lack of capability with respect to access to programs will slow the progress of the research, and delay a larger program of research being developed by the Government. GENERAL INFORMATION This is a Presolicitation Notice in advance of intended solicitation for modification to existing contract to Research Foundation for Mental Hygiene. This notice of intent is NOT a request for competitive proposals. There is no solicitation package available. However, the Government shall consider all responses received within fifteen (15) days of this posting. Interested parties may identify their interest and capability to respond to the requirement, in writing no later than the response date. Written responses to this notice shall contain sufficient documentation to establish a bona fide capability to fulfill the requirement. Written responses shall reference this Notice of Intent No. HHS-N-271-2009-00020-C and may be submitted electronically NO LATER THAN 3:30P.M. EASTERN STANDARD TIME July 17, 2013 to the Contracting Officer, Bruce E. Anderson at banderso@mail.nih.gov and Contract Specialist, Marla Jacobson at jacobsonmj@mail.nih.gov. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. Written responses to this synopsis shall contain sufficient documentation to establish a bonafide capability to fulfill this requirement. The Government will not be responsible for any costs incurred by interested parties in responding to this notice.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIMH/HHS-NIH-271-2009-000-20-C/listing.html)
- Record
- SN03106194-W 20130704/130702235641-61d326c4a648297c5d8644a2a3c1a68a (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |