Diabetes Prevention

TITLE: PPHF 2015 Diabetes Prevention - DM Registries (Diverse Population-based and electronic cohort to assess risk factors for type 2 diabetes, diabetes incidence, prevention approaches and their access and uptake) - Financed solely by 2015 Prevention and Public Health Funds Notice Type: Sources Sought Synopsis: This is a sources sought notice to determine the availability of potential vendors (including, but not limited to, small business (e.g. 8 (a), veteran-owned small business, service-disabled veteran owned small business, HUBZone small business, small disadvantage business, and women-owned small business that can demonstrate the ability to provide a diverse, population-based electronic cohort to develop and validate electronic assessment of diabetes risk factors and incidence and to examine the availability, access and uptake of evidence-based high quality diabetes prevention approaches in accordance with the attached excerpts from the Performance Work Statement (PWS). The National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) is contemplating award of one (1) 5 year Cost Plus Fixed Fee (CPFF) contracts to support Center-wide technical and management support activities. The period of performance shall be for one 12- month base period with four 12-month option periods. Background and Need Chronic diseases - such as heart disease, stroke, cancer, diabetes, and arthritis - are among the Diabetes mellitus (DM) is one of the most rapidly increasing threats to the health of the U.S. public because of the wide range of complications that follow, along with its complicated and costly treatment (National Diabetes Fact Sheet). Incidence of diagnosed diabetes has doubled over the last 15 years and lifetime risk is now 40% (Geiss et al., 2014; Gregg et al., 2014). Moreover, an estimated 86 million Americans have prediabetes, a condition associated with a high risk of developing type 2 diabetes. Randomized controlled trials have shown that in adults structured lifestyle interventions can reduce incidence of type 2 diabetes (Knowler et al., 2002; Tuomilehto et al., 2001; Crandall et al., 2007) and prospective cohort studies have identified several modifiable risk factors for type 2 diabetes that are highly prevalent in the population (Tabak et al. 2012). Furthermore, community translation trials suggest that clinical-community partnerships that refer high-risk people to low cost, high quality prevention programs can achieve adequate weight loss and behavior change to influence diabetes risk (Ali et al., 2012; Li et al., 2014). Economic studies have suggested, however, that the cost-effectiveness of structured lifestyle interventions is likely to depend upon careful risk stratification and availability of high quality, low-cost programs (Zhuo et al., 2012; Zhuo et al., 2013). These findings, along with the diversity of risk profiles in the U.S. call for a multi-tiered response to the type 2 DM epidemic with effective interventions tailored for alternative risk strata, age, and contexts. However, more evidence on the effectiveness of alternative health system approaches and how best to risk-stratify the population for referral to low-cost, evidence-based, high quality prevention programs is needed. In addition to the need for better evidence about how to implement diabetes prevention in the U.S., information about the prevalence and variation of pre-diabetes and diabetes risk factors is limited by the lack of methods and systems for comprehensive surveillance of these conditions. Similarly, the lack of comprehensive cohort studies for diabetes incidence has left knowledge about the magnitude of many modifiable risk factors inadequate. Despite the long history of health system surveillance and registry systems for high cost, complex chronic conditions like diabetes and congestive heart failure, health system registries and effective risk factor management approaches have not been developed for the population at high risk of chronic diseases such as type 2 diabetes. In addition to playing an important role in the surveillance and monitoring of diabetes and its care, registries have been a crucial component of integrated diabetes care to risk-stratify patients, provide timely feedback, and facilitate quality of care improvement (Karter et al.2005) and have played an important role in the improvement of diabetes care and reduction of diabetes complications in the U.S. that have occurred over the past 15 years (Shojania et al. 2004; Ali et al., 2013; Gregg et al., 2014). However, health systems and their measurement systems are largely oriented toward secondary prevention and have not adapted to the needs of primary prevention of type 2 diabetes and related cardio-metabolic conditions. As a result, there has been little development or validation of methods to assess diabetes risk factors, indicators of pre-diabetes, preventive interventions, and quantify progression to diabetes using electronic registries. Project Objective and Purpose The specific objectives to be accomplished are: 1) Establish a diverse, population-based electronic cohort to assess traditional and emerging risk factors for diabetes, progression to diabetes and related morbidity, and the access and delivery of preventive care. 2) Conduct validation studies of risk factors, conditions, and preventive care practices measured as part of the electronic cohorts. 3) Demonstrate the utility of cohorts for sentinel surveillance by assessing and monitoring population-level prevalence of risk factors for diabetes and related morbidity, incidence of diabetes and related morbidity, and the access and delivery of evidence-based prevention programs, including community program utilization. 4) Conduct longitudinal, epidemiologic analyses of the relationship between traditional and emerging behavioral and metabolic risk factors and preventive services and the progression to diabetes and related conditions. 5) Develop, test, and validate alternative risk stratification approaches for the screening, testing, and referral of appropriate persons for diabetes prevention services. ? Project Requirements The contractor shall furnish all necessary labor, facilities, supplies, and equipment to: 1) Develop the design, validation, and analysis of a population-based registry and electronic cohort for diabetes incidence and prevention. The data are expected to permit both serial cross-sectional and longitudinal analyses. The longitudinal analyses include historical perspective data, but should also include prospective data at least through the year 2018. 2) Develop and lead the construction of a detailed protocol and manual of operations that include overall study design, database architecture, definitions of population denominators, key risk factors, covariates and outcomes, validation approaches, and principal analyses. 3) Assemble and standardize data for the construction of a dynamic electronic cohort of a population of at least 100,000 persons, ranging in age from adolescence to older adults, and including different U.S. racial/ethnic groups. 4) Develop appropriate methodologies to combine applicable data sources and variables to estimate sentinel surveillance, identify novel modifiable risk factors, and examine the access and uptake of prevention approaches (within 1 year). 5) Develop analytic protocols to test the reliability and validity of key variables used to define risk factors, diabetes incidence and burden, and behaviors and services of diabetes prevention. 6) Develop protocols and methods for ancillary data collection, where appropriate, to supplement the definitions of risk factors, burden, and prevention services, or to accomplish the analyses of reliability and validity described above in item 5. 7) Using the constructed electronic cohort described in item 3 above, conduct the following analyses: a. Conduct analyses of the reliability and validity of newly developed variables for risk factors, conditions, and preventive care practices, including levels of obesity, physical activity and dietary behaviors, metabolic markers of progression, comorbid conditions, diabetes prevention, and receipt of preventive care services, including nutritional and lifestyle counseling, referral to community programs and use of preventive medications. b. Conduct cross-sectional and longitudinal analyses of population levels and trends of risk factors, conditions, and preventive care practices, including levels of obesity, physical activity and dietary behaviors, metabolic markers of progression, comorbid conditions, diabetes prevention, and receipt of preventive care services, including nutritional and lifestyle counseling, referral to community programs and use of preventive medications. c. Conduct longitudinal analyses of the relationship between traditional and emerging behavioral and metabolic risk factors and prevention services and the progression to diabetes and related conditions. d. Conduct longitudinal analyses of the barriers and predictors of preventive behaviors and receipt and uptake of prevention services. 8) Provide to the CDC: estimates of de-identified analytic dataset with SAS analysis code and data dictionaries used to produce the estimates. The datasets should include the variables related to the specific analyses conducted as part of the contract. 9) Develop manuscripts for publication covering the design and methods, validation, and analyses described above in step 7. The contractor will be required to provide technical and management support services to the NCCDPHP. The contractor must demonstrate its staff capabilities and its arrangement for obtaining scientific and professional experts from various fields, including but not limited to arthritis, cancer control, workplace health, nutrition, physical activity and obesity, diabetes, epilepsy, heart disease and stroke, health research, early child care and education, health disparities, reproductive health, and tobacco. The contractor must demonstrate the capacity to provide project coordination and managing staff that are capable of implementing large-scale evaluation studies, technical projects, program assessments, research and demonstration projects, economic evaluation and cost modeling using sound and current scientific methods. The contractor must demonstrate that these services can be provided in a timely manner. Independently and not as an agency of the Government the Contractor shall provide all qualified personnel, materials, equipment, and facilities - except where individual task orders request the provision of the above mentioned project services to the Government be performed on-site. The task orders issued will be for work consisting of current or long term projects of interest or concern to the U.S. Government. Contractor performance under any order may not begin prior to the submission of a business and technical proposal from the contractor and subsequent approval from the Contracting Officer. Each task order will be negotiated separately, funded individually, and receive a unique task order award number. The contractor is required to provide a Project Director to oversee and address specific issues related to individual task orders. Oversight includes all policy, program, evaluation design issues, assessment issues and support services which pertain to each new assigned task. The contractor will conduct meetings with appropriate Government representatives to discuss activities, which pertain to each new awarded task order. The contractor shall be available to meet, as necessary, with appropriate the appropriate Government representative to present and discuss the overall work plan including milestones and strategies. For each task order the contractor will clearly define an estimated project timeline, total effort that the task is to receive, and considerations that may guide the contractor in its analysis, design or experimentation of the task. Electronic mail format is acceptable. Deliverables for projects under these contracts will be specified within individual requests for task order. Capability Statement: Vendors who believe that they have the ability to satisfy all of the above stated objectives are encouraged to submit a capability statement. The capability statements will be evaluated based on the information provided in relation to the objectives and requirements above and the current in-house capacity to perform the work including: (a) staff availability, experience, and training; (b) prior completed projects of a similar nature; and (c) examples of prior completed contracts, dollar value of the contracts, references, and other related information. Capability statements must demonstrate the requirements outlined above. Capability statements shall include the following information: company name, address, point of contact, phone/fax/email, and business size and status (e.g. small business, 8(a), veteran-owned small business, service-disabled veteran owned small business, HUBZone small business, small disadvantage business, and women owned small business). The remainder of the capability statement should be tailored to the requirements stated above and must demonstrate that similar work has been performed in the past. Submission Instructions: Interested parties having the capabilities necessary to perform the stated requirements may submit a capability statement of up to 25 pages to Jerry Outley (contact@example.gov) via email by 2:00 P.M., EST on April 20, 2015. No facsimile transmissions will be accepted. CAPABILITY STATEMENTS MUST DEMONSTRATE THE MINIMUM REQUIREMENTS OUTLINED ABOVE. The subject line of the email shall be "PPHF 2015 Diabetes Prevention - DM Registries (Diverse Population-based and electronic cohort to assess risk factors for type 2 diabetes, diabetes incidence, prevention approaches and their access and uptake) - Financed solely by 2015 Prevention and Public Health Funds". Capability statements will not be accepted after the due date. ? Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response to the Sources Sought notice. 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 organizations 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. RESPONSES TO THIS NOTICE WILL NOT BE CONSIDERED ADEQUATE RESPONSES TO A SOLICITATION. Primary Point of Contact: Jerry W. Outley Contracting Officer Procurement and Grants Office (PGO) Centers for Disease Control and Prevention (CDC) 2920 Brandywine Road M/S K-69 Atlanta, GA 30341 Email: contact@example.gov Phone: +1 (555) 000-0000