SOURCES SOUGHT
A -- Outcome Performance Measure Development for Persons with Multiple Chronic Conditions (MCCs)
- Notice Date
- 10/18/2013
- Notice Type
- Sources Sought
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- 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-NIDA(AG)-RDSS-13-173
- Point of Contact
- Yvette Brown, Phone: 301 443-2696
- E-Mail Address
-
Yvette.Brown@nih.gov
(Yvette.Brown@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Research and Development (R&D) Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential R&D requirement. Small Businesses are encouraged to respond. BACKGROUND Multiple chronic conditions (MCCs) have been defined by the Department of Health and Human Service (DHHS) in a strategic framework (2010 available online at http://www.hhs.gov/ash/initiatives/mcc/mcc_framework.pdf) as two or more conditions that last a year or more and require ongoing medical attention and/or limit activities of daily living. Approximately 67% of Americans age 65 and older living with MCCs need complex health care services which generate high health care costs. Moreover, their medical care is often fragmented, incomplete, inefficient, ineffective and consequently of poor quality. Improving the quality of health care for people with MCCs requires a multipart effort, one of which rests on developing performance measures reflecting their heterogeneity and outcomes important to them. Since many existing performance measures are disease-specific, new measures must be refined and developed to address the complexity of care for those living with MCCs. New measures may be evaluated by the National Quality Forum (NQF), a nonprofit membership organization created to develop and implement a national strategy for healthcare quality measurement and reporting, using consensus process to endorse national priorities and goals for performance improvement. In 2012, NQF endorsed a measurement framework for MCCs, and that forms a conceptual background for this solicitation (available online at http://www.qualityforum.org/Publications/2012/05/MCC_Measurement_Framework_Final_Report.aspx). Within that framework, this project relates to the Health and Well-Being domain, Treatment and Management type of care, Primary and Specialty Care (outpatient), and the patient and family goals and preferences for care. Many workgroups have expressed interest in patient reported outcome (PRO) measures to examine the health of persons with MCCs, from the NIH-developed Patient Reported Outcome Measurement Information System (PROMIS) and other sources. The PROMIS-29 instrument has been published in Journal of the American Geriatrics Society, December 2012 (doi: 10.1111/j.1532-5415.2012.04240.x.). The Medical Outcomes Study, Short-Form 36 (SF-36) is available online from http://www.qualitymetric.com/WhatWeDo/SFHealthSurveys/tabid/184/Default.aspx. The Veterans Rand 12-item Health Survey (VR-12) has been widely used both inside and outside Department of Veterans Affairs and has shown to have similar properties to SF-36 and has no intellectual property issues. However, additional analysis is necessary to test the validity of the PROMIS tools and VR-12 in an older adult population with multiple chronic conditions. More recently, NQF released a report on how to develop, test, endorse and implement patient-reported outcome performance measures (available online at http://www.qualityforum.org/Publications/2012/12/Patient-Reported_Outcomes_in_Performance_Measurement.aspx). The NQF report describes the distinction between a PRO and a PRO based performance measure and lays out a pathway to move from PROs to NQF-endorsed PRO based performance measure. The latter is an aggregate measure of performance by a practitioner or in an entity considered accountable for the quality of care delivered. PURPOSE AND OBJECTIVES The objective of this contract is to develop routine measurements of health outcomes for older adults living in the community with multiple chronic conditions (MCCs), through validated patient-reported outcome measures of health, functional status and quality of life and to conduct research and prepare materials suitable for quality measure endorsement by the National Quality Forum (NQF). PROJECT REQUIREMENTS/Scope of Work This project consists of two phases, each of which should produce a complete report suitable for submission to the National Quality Forum (NQF) for endorsement of a performance measure on health related quality of life for persons living with MCCs. The reports should address NQF's Measurement Evaluation Criteria for the proposed performance measure. The report should address the criteria that are current as of the initiation of work, include the importance, scientific acceptability, feasibility, and usability of the study (at present they are dated November 2012 and are available online at http://www.qualityforum.org/docs/measure_evaluation_criteria.aspx). If the NQF adopts its proposed two-stage consensus development process, the report should be separated to address each stage. Phase 1 addresses VR-12 while Phase 2 addresses PROMIS-29, although a strongly justified alternate proposal for a different measure for Phase 1 may be considered acceptable. A. Phase 1 Phase 1 involves the analysis of existing data on health-related quality of life on persons with MCCs. The offeror shall propose a PRO-based performance measure, with a preference for the Veterans Rand 12-item Health Survey (VR-12), SF-36 or SF-12, and perform the following; I. Aggregate the PRO measure by using average change; percentage improved or meeting a benchmark. Present a strong justification for the choice and indicate why it is superior to potential alternative measures. II. Refine the performance measure and conduct analyses in a sample of MCC patients from available data against the NQF criteria, for reliability, validity, and threats to validity. The analysis of threats to validity should measure exclusions; missing data or poor response rate; case mix differences and risk adjustment; discrimination of performance. III. Offeror will analyze the quality of care provided to older adults with MCCs, by conducting secondary data analysis of existing data with a measure of health related quality of life to: • Identify where there are disparities in health outcomes (readmissions, change in patient-reported physical health, and/or mental health) for older adults with MCC. • Quantify the magnitude and variation in disparities in health outcomes. • Demonstrate the feasibility of reporting health outcome measures stratified by the presence of MCCs. Source of Data for Phase 1: For this phase, offerors should specify and justify their proposed source of data which is suitable for conducting the required analyses, and assure its availability. Offerors should provide sample size, disease ascertainment, outcome measures and a power calculation for three main analyses. Potential sources of data for this phase include but are not limited to 1) the Medicare Health Outcomes Survey (http://www.hosonline.org/Content/Default.aspx) from the Centers for Medicare and Medicaid Services 2) Health ABC (http://www.grc.nia.nih.gov/branches/ledb/healthabc/index.htm) available from the National Institute on Aging; 3) linkage of the Surveillance, Epidemiology and End Results (SEER) with the Medicare Health Outcomes Survey (MHOS) known as SEER-MHOS and available from the National Cancer Institute; 4) Medical Expenditure Panel Survey (MEPS) which is co-sponsored by the Agency for Healthcare Research and Quality (AHRQ) and the National Center for Health Statistics (NCHS). Currently, as part of the Medicare Health Outcomes Survey, Medicare Advantage (managed care) plans collect information on limited health outcome measures in older adults, including: I. Proportion of patients with improved or maintained physical health over two years based on patient self-report to the Veterans Rand 12-item Health Survey II. Proportion of patients with improved or maintained mental health over two years based on patient self-report to the Veterans Rand 12-item Health Survey These measures are reported to the public in aggregate and used by Centers for Medicare and Medicare Services (CMS) to provide Medicare Advantage Organizations with quality bonus payments based on their performance compared to a benchmark. Currently these measures are reported for all adults age 65+ enrolled in Medicare Advantage health plans, a self-selected group of Medicare beneficiaries. Because the report covers a general older adult population, it is not known if disparities exist, and to what degree, in the quality of care provided specifically for older adults with MCC as measured by these outcomes. It is also unclear if there is variation in the magnitude of the disparity across health providers. B. Phase 2 Phase 2 involves the collection and analysis of data using the PROMIS-29 profile and other instruments from a sample of persons age 65 and over with MCCs. Many short forms developed by the PROMIS group for self-administration to patients have been tested for reliability, face validity (through focus groups, expert panels, cognitive interviewing), construct validity (convergent and discriminate validity) and differential item functioning testing. The PROMIS tools, in particular the PROMIS-29 Profile measure, have not been extensively tested in an adult population age 65 and over. Testing of the PROMIS measures was done via the internet with a primarily healthy adult population. The sample size of older adults, particularly the very old (over age 80 years), was limited. Additional research and analysis is necessary to test the validity of the PROMIS tools in an older adult population with multiple chronic conditions and advance toward a potential quality measure for outpatient care. Specifically, the Contractor shall: I. Prepare a survey instrument containing disease ascertainment questions, PROMIS-29 Profile, VR-12 and SF-36. II. Estimate sample size necessary for the proposed analyses, using a cross-sectional design. III. Obtain required human subjects review and approval and prepare a package for NIH clinical exemption from OMB review. IV. Conduct the survey in the field via different modes of administration (mail, telephone, and internet). Prepare and clean the data for analysis. V. Analyze the data on: • The feasibility of using PROMIS-29 with different modes of administration (mail, telephone, internet) • The construct validity of these survey tools in this population, including convergent and discriminate validity with other measures of physical and mental health • Floor/ceiling effects in the survey measures in this complex population • Differential item functioning • Sensitivity to known group differences in health (e.g. differences based on number of chronic conditions, hospitalization, HCC risk category scores). VI. Refine the performance measure and conduct analyses against the NQF criteria, for reliability, validity, and threats to validity. The analysis of threats to validity should measure exclusions; missing data or poor response rate; case mix differences and risk adjustment; discrimination of performance. REPORTS/DELIVERABLES The following deliverables should be provided to the NIA Contracting Officers Representative (COR) according to the schedule agreed upon at the time of award. Electronic files should use Microsoft Word, or SAS transport, as appropriate. NQF criteria for measure endorsement in effect on September 1, 2014 should be addressed in the deliverables. • Monthly calls with the NIA COR regarding progress • Human subjects approval, waiver or exemption, prior to undertaking any data analysis or human subject research, but no later than 3 months after start of the contract. • Report describing Phase 2, suitable for consideration of the clinical exemption under the Paperwork Reduction Act by the NIH clinical exemption review committee, 3 months after start of the contract. • Phase 1: The materials and analyses necessary to submit a MCC-specific version of the VR-12 based outcome measures for National Quality Forum (NQF) endorsement. o Draft report 9 months after contract starts o Final Report 12 months after contract starts • Phase 2: The materials and analyses necessary to develop a new PROMIS-based health outcome measure in older adults with MCC for NQF endorsement. o Draft Report 18 months after contract starts o Final Report 21 months after contract starts • A complete report of the analysis suitable for presentation and publication in peer-reviewed literature. 23 months after contract starts • A complete cleaned data set with adequate documentation of all elements, and programming code used to produce analyses in Final Reports and manuscript(s), delivered with the Final Report. • Semi-annual reports, every 6 months, no later than 30 days after the end of the reporting period. • Final Report, on or before completion of the contract. ANTICIPATED PERIOD OF PERFORMANCE Two years from date of award, estimated time frame for award is June 2014. OTHER IMPORTANT CONSIDERATIONS The Government is expected to use procedures in FAR Part 15, contracting by Negotiations. The North American Industry Classification System (NAICS) Code 541990 with a size standard of $14.0M. CAPABILITY STATEMENT/INFORMATION SOUGHT: a. Capability Statement - Respondents to this notice must provide, as part of their response, a capability statement to include the following: (1) information regarding the respondents' (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work as described above; (c) prior completed projects of a similar nature; (d) corporate experience and management capability; and, (e) examples of prior completed Government contracts, references, and other related information; (2) respondents' DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZone, etc.) pursuant to the applicable NAICS code; and, (3) any other information that may be helpful in developing or finalizing the acquisition requirement. b. Information Submission Instructions - Respondents should provide responses accordingly: (1) submit information both electronically and by mail. No telephone or facsimile responses will be accepted; (2) format capability statements using Microsoft Word or Adobe PDF including attachments, resumes, charts, etc. Use single space, 12 font minimum and 8 ½ x 11 size paper; (3) organize material in such a manner that clearly identifies and address capability requirements and provide an executive summary; (4) capability statement should not exceed ten (10) single sided pages including references; (5) respondents must send two original copies via mail and one electronic copy via email; (6) responses should be received no later than November 4, 2013 at 4:00 PM Local Time; (7) include respondents' technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses; and (8) send responses to this notice via email to madan.kar@nih.gov and ybrown@mail.nih.gov. The original statements mailed using the U.S. Postal Service should be sent to ATTN: Yvette Brown, Contracting Officer, National Institutes of Health, Office of Acquisitions - NIDA Neuroscience COAC, NIA R&D Contracts Management Section, 6001 Executive Boulevard, Room 8154, MSC 9661, Bethesda, MD 20892-9661. If using a courier service such as the UPS, Federal Express, etc., change the City, State and Zip Code to Rockville, MD 20852. (Please be aware that the U.S. Postal Service's "Express Mail" DOES NOT deliver to the Rockville, Maryland address.) DISCLAIMER AND IMPORTANT NOTES. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. CONFIDENTIALITY No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
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