MODIFICATION
A -- Outcome Performance Measure Development for Persons with Multiple Chronic Conditions (MCC) - Amendment 1
- Notice Date
- 9/29/2014
- Notice Type
- Modification/Amendment
- 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-14-005
- Archive Date
- 10/23/2014
- Point of Contact
- Jon J. Gottschalk, Phone: 3014439456, Fred Ettehadieh, Phone: 301-443-2696
- E-Mail Address
-
jon.gottschalk@nih.gov, fred.ettehadieh@nih.gov
(jon.gottschalk@nih.gov, fred.ettehadieh@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Amendment 01 SYNOPSIS 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 (MCC) have been defined by the Department of Health and Human Services (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 MCC 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 MCC 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 MCC. 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 MCC, and that forms a conceptual background (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. Overall quality of care for populations may be measured with a universal outcome composite. Many workgroups have expressed interest in patient reported outcome (PRO) measures to examine the health of persons with MCC, from the NIH-developed Patient Reported Outcome Measurement Information System (PROMIS) and other sources. The PROMIS-29 instrument, which can be used to survey MCC patients about physical function, anxiety, depression, fatigue, sleep, social roles and pain, was published in the Journal of the American Geriatrics Society, December 2012 (doi: 10.1111/j.1532-5415.2012.04240.x.) and is available from the PROMIS assessment center. The Medical Outcomes Study, Short-Form 36 (SF-36) is available online at: http://www.qualitymetric.com/WhatWeDo/SFHealthSurveys/tabid/184/Default.aspx. The Veterans Rand 12-item Health Survey (VR-12), a short survey instrument about quality of life, 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. Preliminary evaluations of outcome measures can be conducted with available data, with subsequent refinement using newly collected data. 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, 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). The targeted care settings are ambulatory or delivery system level. PROJECT REQUIREMENTS/SCOPE OF WORK This project consists of two phases, each of which should produce a 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 MCC. In this project, MCC should be defined consistent with DHHS (cited above), including at least 10 chronic conditions prevalent in the older population. The project 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). 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 (Base Period) Phase 1 involves the analysis of existing data on health-related quality of life on persons with MCC during the first (base) 12 month period. 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.Construct the PRO performance measure by using average change or percentage improved over time (functional stability or functional gain). Specify how the PRO will be used to determine the numerator, the method for including persons with MCC in the denominator, and any exclusions. 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.Develop and refine risk adjustment of the performance measure using available data and modeling. Evaluate and compare random-effects and fixed-effects approaches. Examine model stability. Evaluate potential risk-adjustment considering potential patient factors: socio-demographic, dual status, comorbidity, disability, and other clinical factors. Consider current NQF guidance on use of socioeconomic status as an adjustment factor. IV.Using the existing data and simulations, assess the potential for the performance measure to demonstrate differences between ambulatory practices; similarly assess the potential to demonstrate differences between health care systems. Consider variations in sample size and proxy response rates. Propose suggestions for future collection of PRO-PM data. V.Prepare documents describing the work to be conducted in Phase 2 that can be submitted to obtain human subjects review/clearance and for NIH clinical exemption from OMB clearance (included in Base). Source of Data for Phase 1: For this phase, the Offeror should specify and justify their proposed source of secondary data which is suitable for conducting the required analyses, and assure its availability. The Offeror shall provide sample size, disease ascertainment, outcome measures and a power calculation for three main analyses. Potential sources of available 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 Medicaid 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 (Option Period) 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 MCC. 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 Offeror 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 or short-term prospective design. III.Obtain required human subjects review and approval or exemption and NIH clinical exemption from OMB clearance. IV.Conduct the survey in the field, either a community or practice setting, 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. Construct the PRO performance measure by using average change or percentage improved over time (functional stability or functional gain). Specify how the PRO will be used to determine the numerator, the method for including persons with MCC in the denominator, and any exclusions. 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. VII.Using the collected data and simulations, assess the potential for the performance measure to demonstrate differences between ambulatory practices; similarly assess the potential to demonstrate differences between health care systems. Propose suggestions for future collection of PRO-PM data. REPORTS/DELIVERABLES The offeror shall conduct monthly calls with the NIA Contracting Officer's Representative (COR) regarding progress. In addition, the following deliverables shall be provided to the NIA COR and Contracting Officer (CO) 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, 2015 should be addressed in the deliverables. A. Semi-annual progress reports : The Offeror shall submit semi-annual progress reports that include any changes in Offeror personnel, the number of staff-hours committed to the contract project for the reporting period, the source and number of data points entered into the database for phase 1 and collected for phase 2, a summary of revisions to the codebook completed during the reporting period, a list of publications resulting from use of the database, and any technical problems reported by investigators and how they were addressed/resolved. Semi-annual reports shall be submitted to the COR and CO within thirty (30) calendar days of the end of each six (6) month period of the contract. The initial report shall be submitted for the first full six (6) months of the contract performance including any fractional part of the initial month. Thereafter, the reporting period shall consist of six (6) full calendar months. A semi-annual report will not be required for the period when the final report is due. B. Human subjects : The offeror shall submit two copies of documentation of human subjects exemption, waiver, or IRB approval for Phases 1-2 before undertaking any data analysis or human subject research, and no later than 3 months after the start of the contract. C. Clinical exemption package for Phase 2 : The Offeror shall submit two copies of the materials to be submitted to the NIH Clinical Exemption Review Committee for determination of clinical exemption for Phase 2, no later than 3 months after the start of the contract. This report shall be suitable for consideration of the clinical exemption under the Paperwork Reduction Act by the NIH clinical exemption review committee. D. Phase 1 - Draft repor t: The Offeror shall submit two copies of the materials for NQF submission to review a proposed quality measure of the VR-12 in MCC patients (or other instrument, if specified in the final contract) as a draft, no later than 9 months after the start of the contract. This report shall include the materials and analyses necessary to submit a MCC-specific version of the VR-12 based outcome measures for E.P hase 1 - Final report: The Offeror shall submit two copies of the final materials for NQF submission to review a proposed quality measure of the VR-12 in MCC patients (or other instrument, if specified in the final contract), no later than 12 months after the start of the contract. F. Phase 2 - Draft report: The Offeror shall submit two copies of the materials for NQF submission to review a proposed quality measure of the PROMIS-29 in MCC patients, as a draft, no later than 18 months after the start of the contract. This report shall include the materials and analyses necessary to develop a new PROMIS-based health outcome measure in older adults with MCC for NQF endorsement. G. Phase 2 - Final report: The Offeror shall submit two copies of the materials for NQF submission to review a proposed quality measure of the PROMIS-29 in MCC patients, t, no later than 21 months after the start of the contract. H. Draft data set and documentation: The Offeror shall submit two copies of the cleaned data set with documentation of all elements, and programming code used to produce analyses in Final Reports and manuscript(s), 23 months after the start of the contract. I. Draft manuscript: The Offeror shall submit two copies of the complete report of the analysis suitable for presentation and publication in peer-reviewed literature, 23 months after start of the contract. J. Final Report: The Offeror shall submit two copies of the Final Report, one each to the CO and COR, on or before completion of this contract. The final report shall include a summation of the work performed under the entire contract period of performance, including data used for Phase 1 and collected for Phase 2, publication resulting from use of the database, and any technical problems reported by investigators and how they were addressed/ resolved. A complete cleaned data set with adequate documentation of all elements, and programming code used to produce analysis and manuscript(s). In addition, two (2) CDs of the most up-to-date version of the database shall be submitted to the COR with the final report. 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 October 8, 2014 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 jon.gottschalk@nih.gov and ettehadiehf@mail.nih.gov. The original statements mailed using the U.S. Postal Service should be sent to ATTN: Jon Gottschalk, Contract Specialist Fred Ettehadieh, 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.
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