Identifying Health Care Needs in West Texas Through Rural Health Research: Lessons from Project FRONTIER

1. Identifying Health Care Needs in West Texas Through Rural Health Research: Lessons from Project FRONTIER Matthew E. Lambert, Ph.D.Cathy Hudson, B.S.Adriana Gamboa, B.A.

2. Rural vs. Urban Living • Over the past 50 years there has been an increasing trend toward urbanization in the United States. • In 1970 26.4% of the population lived in rural areas with a decline to 24.8% in 1990. • As of 2010 only 19.3% of the population lived in rural areas.

4. Where the Jobs Are • Without rural communities many jobs would not exist!

7. Problems in Rural Living • Lower Socio-Economic Status • Poorer Educational Status • Less Access to Healthcare Services and Poorer Health

11. Why is Rural Health Research Needed? • Understand the Health Needs of Rural Communities • Provide Basis for Health Care Service Delivery • Plan Specific Interventions for Rural Health Care • Address Disparities in Health Care Access • Preserve Rural Communities and Their Economic Contributions

12. Lessons From Project FRONTIER

13. Mission Statement The mission of Project FRONTIER is to explore the natural course of chronic disease development and its impact on longitudinal cognitive, physical, social, and interpersonal functioning in a multi-racial adult sample from rural communities of West Texas. Such exploration will be used to develop programs for effective disease management, preservation of cognitive functioning throughout the lifespan, and improvement of the overall health of individuals living in rural West Texas.

14. Cochran County Aging Study was rechristened as Project FRONTIER (Facing Rural Obstacles to healthcare now Through Intervention, Education & Research) in 2009. • Project expansion in 2009 with addition of participants from Parmer County. • Further participant expansion occurred in 2011 with the addition of Bailey County • Recent expansion now includes participants from Hockley County.

15. Project FRONTIER Locations

16. Data Collection and Usage Process • Data Collected in Local Communities • Community Coordinators Schedule and Manage Data Collection • Data Files and Biological Specimens Transferred Back to TTUHSC for Analysis and Storage • Consensus Diagnostic Review of Every File • Specific Research Questions Posed for Analysis in the Data • Results of Analyses Published in Peer Reviewed Journals

17. Data Collection Process Initial Contact File Sent to Lubbock Research Visit Medical Exam Consent Clinical Labs 2-3 hrs total Testing Scored Blood/ Serum Samples Sent To Biobank Interview Cognitive Testing Files Prepped -Consensus Review New Files Merged into Dataset- Ready for Researchers Analysis of Samples (incl. APOE, AS3MT) Feedback Letter sent to Participant Data Entry & Verification Consensus Review Meeting Feedback Letter sent to Provider (if requested)

18. Variables Medical Examination: • Standardized medical exam completed by local MD, NP, or PA • Review of systems – general, dermatology, HEENT (head, eyes, ears, nose, throat), breast, respiratory, cardiovascular, gastrointestinal, genitourinary, endocrine, hematologic, musculoskeletal, neurological, psychiatric, and functional • Hachinski Ischemic Scale • Neurological assessment

19. Variables Fasting blood work: Biobank: serum and DNA • In addition to the clinical blood work, each participant will be asked to provide additional blood (3 tablespoons) for storage. This will include 2 10mL serum-separating tubes (tiger-top) that will be spun and aliquoted into 500 microliter aliquots and stored in a -30* freezer. One 10mL whole blood tube (yellow-top) will be collected and frozen for later extraction of DNA. All samples will be transported back to the TTUHSC Department of Neurology and stored in a -80* freezer. The Project FRONTIER Biobank is solely for storage purposes; any analyses of specimens from the Biobank will first be reviewed and approved by the IRB. Any participant can refuse participation in the Project FRONTIER Biobank.

20. Variables Interview: • Portions of the CDC Behavioral Risk Factor Surveillance System (BRFSS) questionnaire – diabetes, hypertension, cholesterol, cardiovascular disease, cancer, women’s and men’s health, physical activity • Demographics, education, residential, and occupational history • Medical history (self and family) • Medication use and dosage (prescription, over-the-counter, vitamins, and supplements) • Affective screenings (Geriatric Depression Scale & Beck Anxiety Inventory) • Substance use history (tobacco, alcohol) • Informant report of participant’s cognition, memory, and daily functioning • Objective measures: • Blood pressure and pulse (3 readings each) • Height and weight • Body Mass Index (BMI) • Abdominal and neck circumference • Blood oxygen saturation • Body impedance (body fat percentage) • Heel scan (bone density – Parmer County only)

22. Participants as of May 2014

23. Cohort Demographics

24. Census 2012 estimates

25. What we’ve learned so far • Cochran County

26. What we’ve learned so far • Parmer County

27. What we’ve learned so far • Bailey County

28. Cognition

29. Emotional Health

30. Project FRONTIER Research Areas • Association between Coronary Heart Disease and Arsenic Exposure • Language Proficiency and Diabetes and Cardiovascular Disease Status • The relationship between GGT and Cardiovascular Disease • The Role of Vitamin B-12 and Depression • Symptom Overlap in the Clinical Dementia Rating Scale and Geriatric Depression Scale • Comprehensive Risk Factors for Suicide Risk among Rural Adults • End of Life Decision Making in Rural West Texas • Association of hypothyroidism with arsenic exposure • Food insecurity in Rural West Texas • Algorithm Development for Polysomnography to Diagnosis Obstructive Sleep Apnea • Relationship between allostatic load and glucocorticoid receptor polymorphisms in individuals living in rural West Texas • Comparing Efficacy of Diabetes Education Models in Large and Rural Medical Settings • Reducing Prostrate Cancer Incidence From Arsenic Exposure

31. The Project FRONTIER Database • Large Database with over 2000 unique variables and 1200 participants • Requires Processes for Data Preparation, Entry and Management • Data Preparation: Conversion from raw entry to entry form in QDS Database Program • Data Entry: Entry and Verification Phase • Data Management: Adjustments to Database, Data Utilization, and Data Security

32. Database Management • Conversion of data from QDS program to SPSS/SAS • Addition and deletion of variables over time based on epidemiological research • Repeated checks of data integrity • Maintaining data security (HIPPA - standards) • Creating data subsets for specific research studies – identified vs. de-identified data

33. Data Utilization • Completion of Research Proposal • Research basis, research questions, population-methodology-statistical analyses, protection of human participants, variables included, and results dissemination process • Review by Scientific Advisory Committee • Completion of Data Use Agreement

34. Data Use Agreement • Project FRONTIER • DATA USE AND PUBLICATION AGREEMENT (DUPA) • This Data Use and Publication Agreement (“DUPA”) is between the F. Marie Hall Institute for • Rural and Community Health (“Covered Entity”) and ____________________ (“Recipient”). • This Agreement is effective on ____________________ (date). •  The Health Insurance Portability and Accountability Act of 1996 (HIPAA) and its • associated regulations at 45 C.F.R. Part 160 and 164 (Privacy Rule) requires a Data Use • Agreement in connection with the disclosure of a limited data set (LDS) by Covered • Entity to Recipient; •  Recipient conducts research, performs public health activities, or performs health care • operations using protected health information (PHI) in a LDS as defined by the HIPAA • Privacy Rule regulations at 45 C.F.R. 164.514(e); •  Covered Entity wishes to provide to Recipient PHI in a LDS for the purposes of research. • In consideration of the above requirements, the parties agree: • 1. DATA USE • 1.1. I will receive de-identified data and will not attempt to establish the identity of, or • attempt to contact any of the Project FRONTIER subjects. • 1.2. I will not further disclose these data beyond the uses outlined in this agreement and my • data use application. • 1.3. I will require anyone on my team who utilizes these data, or anyone with whom I share • these data to comply with this DUPA. • 1.4. I will accurately provide the requested information for persons who will use these data • and the analyses that are planned using these data. • 1.5. I will respond promptly and accurately to annual requests to update this information. • 1.6. I will comply with any rules and regulations imposed by my institution and its • institutional review board in requesting these data. • 2. PUBLICATIONS and PRESENTATIONS • If I publish abstracts using data from Project FRONTIER, I agree to the following: • 2.1. I will cite the F. Marie Hall Institute for Rural and Community Health as the source of • data and the Project FRONTIER funding sources in the abstract as space allows. • 2.2. I will provide abstracts to be listed on the F. Marie Hall Institute for Rural and • Community Health website for users to see either as they are accepted or after they are • presented. • If I publish manuscripts using data from Project FRONTIER, I agree to the following: • 2.3. On the author line of the manuscript, after the named authors, I will include the phrase • “and the F. Marie Hall Institute for Rural and Community Health*” with an asterisk • referring to the following statement and list of names: • *Data used in the preparation of this article were obtained from the F. Marie Hall Institute for Rural and Community Health Project FRONTIER database. • The F. Marie Hall Institute for Rural and Community Health contributed to the design • and implementation of Project FRONTIER and/or provided data but did not participate • in the analysis or writing of this report. Project FRONTIER investigators include • ________________________________. • 2.4. I will include language similar to the following in the methods section of my • manuscripts in order to accurately acknowledge data gathering by the Project • FRONTIER personnel. Depending upon the length and focus of the article, it may be • appropriate to include more or less than the example below, however, inclusion of some • variation of the language shown below is mandatory. • "Data used in the preparation of this article were obtained from the F. Marie Hall • Institute for Rural and Community Health Project FRONTIER database.” • 2.5. I will acknowledge funding of Project FRONTIER in the support acknowledgement • section of the manuscript using language similar to the following: • “Project FRONTIER is funded by The F. Marie Hall Institute for Rural and Community • Health at Texas Tech University Health Sciences Center. • 2.6. I will submit all manuscripts to the Project FRONTIER PI and/or Advisory Committee • prior to submitting to a journal. This review will not be a scientific review, but is • intended to ensure that items above are correctly implemented. The PI and Advisory • Committee will maintain confidentiality of the manuscript and will complete its review • within two weeks.

35. 2.7. I will ensure that Investigators who utilize Project FRONTIER data use appropriate • administrative, physical and technical safeguards to prevent use or disclosure of the data • other than as provided for by this Agreement. • 2.8. I will report any use or disclosure of the data not provided for by this Agreement of • which I become aware within 15 days of becoming aware of such use or disclosure. • 3. GENERAL • 3.1. This Agreement may be terminated: • 3.1.1. By Covered Entity on material breach by Recipient, provided: • 3.1.1.1. Covered Entity gives Recipient written notice of the breach, and • 3.1.1.2. Recipient fails to cure the breach within thirty (30) days of receipt of such • written notice. Covered Entity may agree to extend the time for • Recipient’s cure of the breach. • 3.1.2. By either party upon thirty (30) days written notice to the other, or • 3.1.3. In a written agreement signed by both parties. • 3.2. The responsibilities of Recipient described in this Agreement shall survive termination • of this Agreement. • 3.3. This Agreement shall be governed and interpreted in accordance with the laws of the • State of Texas. • 3.4. This Agreement may not be assigned by Recipient without the prior express written • consent of the Covered Entity. • 3.5. None of the terms of this Agreement are intended to create, nor shall be construed to • create, any relationship between the parties other than that of independent entities • contracting with each other solely for the purpose of transferring a LDS. • I understand that failure to abide by these guidelines will result in termination of my privileges to access Project FRONTIER data. • IN WITNESS WHEREOF, the parties have executed this Agreement on the effective date stated • above. • Recipient • Signed by: ______________________________________________ Date __________ • Print or Type Name: _______________________________________ • Title: ___________________________________________________ • Organization: ____________________________________________________________ • Address: ________________________________________________________________ • City: ___________________________________ State: __________ Zip: ____________ • Covered Entity • Signed by: _______________________________________________ Date __________ • Print or Type Name: ________________________________________ • Title: ____________________________________________________ • Organization: F. Marie Hall Institute for Rural and Community Health • TTUHSC Office of Research • This Agreement must be signed by a TTUHSC signatory authority either in Research or • Sponsored Programs. • Signed by: ________________________________________________ Date _________ • Print or Type Name: ________________________________________ • Title: ____________________________________________________

36. Questions