Sources Sought Notice – Healthy Aging in Neighborhoods of Diversity across the Life Span (HANDLS) Home Visit Study

Notice Type: Sources Sought Notice

Posted Date: 29-DEC-15

Office Address: Department of Health and Human Services; National Institutes of Health; National Institute on Drug Abuse; 6001 Executive BoulevardRoom 4211 - MSC 9559 Bethesda MD 20892

Subject: Healthy Aging in Neighborhoods of Diversity across the Life Span (HANDLS) Home Visit Study

Classification Code: A - Research & Development

Solicitation Number: HHS-NIH-NIDA(AG)-RDSS-16-017

Contact: Heather M. Orandi, Contract Specialist, Phone 3014436162, Email [email protected] - Yvette Brown, Senior Contracting Officer

Setaside: N/AN/A

Place of Performance (address): Bethesda, MD

Place of Performance (zipcode): 20892-9661

Place of Performance Country: US

Description: Department of Health and Human Services

National Institutes of Health

National Institute on Drug Abuse

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

The National Institute on Aging (NIA) has a need for a project entitled, The Healthy Aging in Neighborhoods of Diversity across the Life Span Home Visit Program (HHVP). Health disparities are marked differences or inequalities in health measures, such as disability or mortality, between two or more population groups based on race or ethnicity, gender, education, socioeconomic status (SES), or other criteria. Health disparities among ethnic minorities, the poor, and the medically underserved are well documented nationally and internationally. From perspective of the National Institute on Aging (NIA), understanding health disparities is linked to understanding aging because health disparities are characteristically seen in commonly occurring age-associated diseases such as cardiovascular and cerebrovascular disease as well as diabetes mellitus and cancer. The challenge to investigating health disparities and minority aging is designing and implementing studies that recruit and retain a racially and socioeconomically diverse cohort. Unfortunately, the failure to consistently include minority and socioeconomically diverse research participants has hampered efforts to address disparate health outcomes and conduct successful translational research in many areas of clinical research. With this background, the NIA developed the Healthy Aging in Neighborhoods of Diversity across the Life Span (HANDLS) study to investigate whether race and socioeconomic status influence health and age-related health disparities separately or synergistically as co-factors of behavioral, psychosocial, and environmental conditions.

HANDLS is a prospective population-based interdisciplinary, longitudinal study with an initial cohort of 3721 individuals who represent working-age African Americans and whites initially between 30-64 years old recruited as a fixed cohort of participants by household screenings from an area probability sample of twelve neighborhoods (contiguous census tracts) in Baltimore City and one dress rehearsal neighborhood. Power analyses for longitudinal analyses after twenty years of follow-up with repeated assessments every three years specify at least 80% power for a minimum sample size of 30 participants per cell defined by race (African American, white), socioeconomic status (self-reported household income based on 125% of the 2004 Health and Human Services Poverty Guidelines), age (seven 5-year age groups 30-64 years old), and sex. We identified neighborhoods that were likely to yield representative distributions of Baltimore City with sufficient individuals to fill the sampling design based on 2000 census data. The study domains examined in the baseline wave included: cognitive function, nutrition, neighborhood environment, anthropometry, cardiovascular health, physical performance, health services, molecular markers, genomics and psychology. The follow-up waves have added measures on personality, nephrology, neuroimaging, health literacy, and economic strain.

The Wave 3 re-visit examinations in the study began in July 2009. Evaluation of the success of the retention strategy is incomplete but data from the neighborhoods revisited thus far shows that the retention rate is 91% for those participants able to complete their follow-up examination. However, as HANDLS collects further information about our participants, it has become apparent there is a sub-population whose health status prevents them from completing the follow-up examination on NIA's Medical Research Vehicles. HANDLS is at risk for collecting biased follow-up data because this subpopulation is more likely to be lower socioeconomic status (OR = 3.15 95%CI = 1.70-5.82) and older (OR = 3.80 95%CI = 1.92-7.51). This suggests that NIA must examine this subgroup of participants to accurately assess the extent to which they have changed since the initial assessment. To avoid non-random missing data, the NIA developed the HANDLS Home Visit Program (HHVP). This protocol is designed to allow participants who are home bound or disabled to continue to participate in the HANDLS study as scheduled. Epidemiologists are unanimous in advising that collecting as complete data as possible is the most effective way to avoid biases introduced by non-random missing data. The International Conference on Harmonization (ICH-E9) guidelines state, "no universally applicable methods of handling missing values can be recommended" and they advise collected as much complete data as possible. Providing an alternative to the examination visit on the Medical Research Vehicles allows the NIA to collect valuable data about the influences of race and socioeconomic status on the development of age-related health disparities and disability among socioeconomically diverse African Americans and whites in Baltimore.

PURPOSE AND OBJECTIVES

This procurement shall acquire the services of a contractor for a 5-year period to perform home-based medical evaluations for HANDLS participants who are unable to visit the NIA's Medical Research Vehicles (MRVs) for their follow-up medical evaluations. This HANDLS substudy is called the HANDLS Home Visit Program (HHVP). Initially, the NIA will require approximately 50 home visits per year conducted primarily in the Baltimore metropolitan area, but also in other areas to which participants may have moved. Home visit medical evaluations shall be performed according to the HANDLS timeline specified for participants' scheduled follow-up MRV visits. The first year will also include home visits that are out of sequence (behind the usual scheduled appointment date) because HANDLS was unable to evaluate the participant on the MRV when initially scheduled.

The main objectives of the procurement are: (1) to perform follow-up study evaluations on all HHVP participants identified by the Government; (2) create, implement, and manage a database tracking system for classifying all HHVP participants. The database will provide complete verification of the status of HANDLS home visit participants and shall include information indicating who are active and willing to participate, who completed a home visit, who have died, and who refuse the home visit (as they occur), and also up-to-date demographic and contact information for all home visit participants; (3) Increase the value of the study by reducing the biasing effect of "informative censoring" (non-random missing data); (4) Expand the collection of biological samples in participants who have developed substantial comorbidity and disability.

PROJECT REQUIREMENTS/SCOPE OF WORK

Requirements, Responsibilities and Work to be Performed: Independently, and not as an agent for the Government, the Contractor shall furnish all the necessary services, qualified personnel, material equipment and facilities, not otherwise provided by the Government needed to perform the Statement of Work outlined below. This procurement calls for performing the following activities for 5-years:

* Establish initial telephone or in-person contact with all HHVP participants to update contact information, confirm their current eligibility status, and their willingness to participate in the HHVP

* Develop and maintain web-based appointment calendar system for the HHVP and schedule in-home study evaluations to which the Project Officer and his colleagues shall have access

* Provide participants with a NIA-produced detailed description of the study and procedures

* Obtain informed consent for participation in the home visit study using NIA IRB-approved informed consent documents

* Perform in-home follow-up evaluations as outlined in the HHVP protocol

* Collect, process, prepare for delivery, and ship or deliver blood, urine and saliva samples to be used for basic tests of clinical chemistry, DNA extraction and storage of cells, serum and plasma

* Provide to NIA a database with all tracking information and data collected, maintaining full compatibility with the HANDLS database. The NIA Project Officer will supply information on the HANDLS database to insure compatibility with ongoing data collection

* contact, Recruit and Schedule HHVP participants: The NIA will provide the Contractor with a list of names, telephone numbers, and addresses of the HHVP participants currently on file

* Develop Electronic System for Tracking and Recording Information Collected during the Telephone contact: At Contract initiation, the Contractor shall provide a plan for data coding, data entry, and electronic transmission of these data to the NIA Contracting Officer's Representative (COR) that is compatible with ongoing methods for data storage and transmission used by HANDLS

* Develop Screening Questionnaire: The Contractor shall develop a screening questionnaire to be used for confirming general health status, presence of chronic disabling conditions and level of mobility, and review of active medications, all of which are criteria for home visit examinations. The contractor shall schedule home visits in person or on the telephone. The questionnaire shall be developed in collaboration with the NIA COR and his colleagues and shall contain a subset of the screening questionnaire used currently in HANDLS

* Conduct the Home Visit Protocol: The NIA will provide the Contractor with a list of information to be collected during the home visit, including specific test measures, and the requirements for coding of data. The Contractor will develop a Manual of Procedures (MOP) based on the NIA provided HHVP Operations Manual, including electronic data methodology, procedures to minimize risk to participants, procedures for training and certification of examiners, and detailed procedures for data coding, entry, quality control, and electronic data transmission. Prior written approval of the MOP by the NIA COR is required before beginning any home visits or telephone contacts. The length of the home visit is estimated between 3-5 hours

DATA TO BE COLLECTED DURING HOME VISIT

(a) Informed Consent - The NIA will provide Institutional Review Board approved consent forms for the use by the Contractor. The Contractor shall obtain informed consent from each participant before performing any testing or data collection. The Contractor shall be responsible for accurate completion of all required information. All Contractors who have access to personally identifiable information or who interview or examine HANDLS participants shall receive appropriate training and certification (see appendix). The Contractor shall maintain a paper and electronic copy of all signed informed consent documents and send the original to the NIA COR biweekly. The NIA will provide the HANDLS medical release form, and the Contractor shall obtain consent for release of medical information from the home visit participants.

(b) Collection of Blood, Saliva and Urine samples - A blood sample of 87.5 ml, divided into 10 tubes, as well as a urine and saliva sample shall be collected for local home visits. For local, same-day home visits, the Contractor shall collect the samples, store them in melting ice, and deliver them within 5 hours of collection to the NIA Core Laboratory. For out-of-town home visits to locations more than one day of travel from Baltimore, the Contractor shall collect one 10cc EDTA tube to be used for DNA extraction and a saliva sample, and ship them by overnight courier to the NIA Core Laboratory the same day of collection. The samples should arrive at the laboratory on the following days and hours: Monday through Friday 8:30 a.m. - 4:30 p.m. Local Time. The Contractor shall follow appropriate labeling and packaging for shipment of biological materials.

(c) Medical History and Physical - The Contractor shall begin the examination by obtaining a blood pressure reading and performing an EKG to assess each participant's medical stability and ability to participate. The Contractor shall terminate the home visit examination if the participant's blood pressure is >160/100, pulse >120 beats per minute, or respiratory rate >30, or the participant is unable to complete the examination in the judgment of the examiners. The Contractor shall report terminations to the HANDLS medically responsible physician immediately. If none of the termination criteria are met, then the Contractor shall proceed with the physical examination and medical history, recording data using electronic data capture provided by the NIA COR.

(d) Other Assessments - The home assessment shall also include: (1) Selected anthropometric measures including weight, height, waist circumference and hip circumference; (2) Three serial measures of blood pressure; (3) A recording of current medications and dietary supplements taken regularly; (4) A measure of hand grip using the dynamometer; (5) A battery of cognitive tests assessing memory, executive function, verbal fluency and knowledge, and spatial ability. In addition to dementia screening using the Mini-Mental State Examination, the Contractor will administer the Benton Visual Retention Test (BVRT), California Verbal Learning Test, Card Rotations, Prospective Memory, Wechsler Adult Intelligence Scale Digit Span Forward and Backward, Identical Pictures, Clock Drawing, Brief Test of Attention, Wide Rage Achievement Test, Trail Making A and B, animal fluency; (6) Symptoms of depression assessed by oral administration of the Center for Epidemiologic Studies Depression (CES-D) scale; and (7) The HANDLS Home Visit Questionnaire provided by the NIA COR who will also provide the order in which these instruments shall be administered.

The NIA COR and his colleagues will work closely with the Contractor, including training and routine observations of assessments to maintain consistency of all evaluations with procedures used by HANDLS.

(e) Quality Control: All measures shall be administered and scored according to standardized procedures provided by the NIA COR. The Contractor shall include a detailed plan for training and certification of examiners and maintenance of quality control in the MOP. This shall include monitoring by the NIA COR and demonstrated proficiency at administering, scoring, and data entry of these tests and inventories.

The Contractor shall develop and provide in the MOP a detailed plan to score all tests and information collected electronically during the home visit based on the NIA-provided HHVP Operations Manual, to enter such information into electronic database, and to ensure the accuracy of the data collection, scoring and data entry. NIA will provide the structure of the database for compatibility with existing HANDLS data. The Contractor shall score and independently re-score, and enter and independently re-enter all manually administered cognitive and neuropsychological tests, and the CES-D. Data shall be complete assessments with minimal missing data and free of scoring and entry errors.

Qualified sources should have the ability to provide:

* A licensed Nurse Practitioner with demonstrated experience and clinical judgment, nursing and phlebotomy skills in performing in-home examinations (including medical histories and physical examinations) in racially and socioeconomically diverse working-age and older participants; the Nurse Practitioner should have demonstrated management capabilities for supervising other staff in the contract and in conducting other work performed by this contract. Must have current certification and must maintain certification in Basic Life Support (BLS) and Advanced Cardiac Life Support (ACLS).

* A psychometric technician with demonstrated experience administering cognitive and neuropsychological tests, and administering psychiatric screening instruments, and behavioral, attitude, and personality screening inventories. Must have current certification and must maintain certification in Basic Life Support (BLS).

* All in-home staff should be familiar and comfortable with using a computerized data entry for recording information gathered during histories, physicals, interviews, and inventories.

* The transport of bio-specimens with appropriate packaging for biosafety and delivery within 5 hours

* Capability of local travel in the Baltimore region and occasional travel outside the Baltimore region with driver licenses and appropriate insurance.

* Capability to work whenever participants are available including holidays, weekends, and evenings.

* Capability for electronic data transfer.

REPORTS AND DELIVERABLES

Data Transfer: The Contractor shall forward to the NIA COR all data generated as part of this contract in an electronic format approved by the NIA COR.

* Materials and information forwarded to the NIA COR bi-weekly

* Original informed consent documents signed by HHVP participants, the consenters, and the witnesses

* A list of all participants who refused to participate or request to withdraw or delay participation in the study with their reasons provided

* A report with any abnormal or medically emergent results or findings from the home visit evaluation and data collection and actions taken to address medical emergency or abnormal finding materials and information forwarded to the NIA COR monthly

* All tracking information including data associated with all activities, telephone contacts, participants enrolled into the home visit program, participants scheduled for home visits, all contacts and assessments performed, and related contact information

* The number of blood, saliva and urine samples obtained and forwarded to the NIA

* All other data collected under this contract

The Contractor shall submit all documentation, data, and reports electronically to the NIA COR via email.

Monthly Data Transfer: The Contractor shall by the fifth calendar day (or any other mutually agreeable calendar day) after each month of the contract perform the monthly electronic data transmission to the NIA COR.

Final report: The Contractor shall submit a final report on or before the last day of the contract. This report shall include a summation of the results of the entire contract work for the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the numbers and types of evaluations performed as a result of the Statement of Work.

ANTICIPATED PERIOD OF PERFORMANCE

Five years from date of award, estimated time frame for award is on/or about November 2016.

OTHER IMPORTANT CONSIDERATIONS

Immediate notification by phone to the HANDLS Responsible Physician about:

* Any unexpected and untoward event that occurs during the Home Visit

* Any abnormal or medically emergent results or findings from the home visit evaluation and data collection

* Actions taken to address medical emergency or abnormal findings

Preparation and distribution of letters, and reports to participants and primary care physicians as appropriate using NIA-supplied on-site facilities; Preparation for shipping, tracking and review of clinical laboratory data completed by off-site laboratory; Delivery, processing and tracking of biological samples for NIA IRP Bio-specimen repository and keeping record of samples processed in accordance with NIH policies; Emergency and resuscitative services provided to HHVP participants as needed; The Contractor shall have employees available to work seven days per week or as required by the approved protocol; The Contractor shall prepare appropriate documents and financial control information to facilitate the NIA's participation compensation mechanism via debit card or other means furnished by the NIA COR. Required staff includes a part-time Principal Investigator, full-time Certified Registered Nurse Practitioner, full-time Licensed Practical Nurse, a full-time qualified neuropsychological tester, and a part-time database programmer, all of whom are regarded as key personnel.

The Contractor shall develop a plan for secure storage and electronic transfer of all data. All data under this contract shall be property of the NIA. Replication, dissemination or use of results is prohibited without express written permission of the COR. Data will be used by NIA scientists and their collaborators to address scientific questions related to the aging process and health disparities as well as predictors of health and quality of life in HANDLS participants. All data collected under this contract shall be forwarded to the NIA. Results will be disseminated to the scientific community via presentations at scientific meetings and publications in professional journals. Collaboration of the Contractor's Principal Investigator with NIA scientists is highly encouraged. However, the Contractor is explicitly prohibited from publishing or disseminating any information based on the work performed under this contract without prior, written approval from Chief, Health Disparities Research Section (HDRS), Laboratory of Population Science, NIA and the NIA COR in accordance with HHSAR 352.224-70, Confidentiality of Information. The confidentiality of information collected from HANDLS participants is protected under the Privacy Act as described in the Federal Register, Vol, 53., No. 225, Tuesday, November 22, 1988, pp. 47313-4. The Health Disparities Research Section (HDRS) will have access to and use of all data at any time. All data shall be transmitted electronically to the NIA. All data collected by the Contractor shall be maintained under controlled and secure conditions for the duration of the contract period. During the performance of this contract and upon completion of the contract, all data collected under this contract shall be the property of the NIH.

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 AND 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 1/2 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 January 28, 2016 at 4:00 p.m. 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 mailto:[email protected] and mailto:[email protected]. The original statements mailed using the U.S. Postal Service should be sent to ATTN: Heather Orandi/Fred Ettehadieh, 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).

Link/URL: https://www.fbo.gov/spg/HHS/NIH/NIDA-01/HHS-NIH-NIDA(AG)-RDSS-16-017/listing.html