The Veterans Aging Cohort Study: Understanding and Improving Outcomes in HIV Infection David Fiellin, MD, Cynthia Brandt, MD and Amy Justice, MD, PhD For the VACS Project Team and Informatics Fellowship

HIV is a Complex Chronic Disease Major debilitating illness with protracted survival Life long toxic treatment Multi-morbidity the rule Medical disease Psychiatric disease Substance use/abuse Racial /ethnic, economic, and sexual minorities Population ages ~1 year with each year

Patient Outcomes in HIV in 2007 Aging Comorbid Disease, Behaviors, & NonARV Toxicity HIV HIV Treatment

Hypothesis We can improve HIV outcomes by improving our management of complexity HIV conditions and treatment Medical, psychiatric comorbidity Aging Behavioral issues Substance use Adherence Diet, exercise

VACS Goals Quantify effects of aging, comorbid disease, substance use, and drug toxicity on patient outcomes in HIV. Compare these effects among those with and without HIV infection. Identify modifiable mediators of survival; quality of life; and incidence and severity of disease. Design and implement large strategy trials using the EMR and behavioral interventions.

VA Near Ideal Laboratory Largest provider of HIV care Near “closed system” of care 96% report getting all HIV meds from VA Older population (10 yrs older than CDC) Enriched with people of color Appropriate HIV uninfected veteran controls VA culture of evidence based medicine Excellent national databases for benchmarking

VA Health Information System Pharmacy data (fill and refill) Administrative data (inpt/ outpt ICD-9) Laboratory data Mortality data Includes progress notes Built in messaging and provider prompts Links with decision support Integrated across modules

VACS Strategies Prospective, consented cohort VA ID and GIM clinics All HIV positive patients seen are eligible GIM patients “matched” to HIV patients All electronic medical record (EMR) data Self completed surveys supplement EMR Permission to recontact for intervention Followed for long term outcomes Validate data via triangulation

Stratified Enrollment by Race/Ethnicity

Stratified Enrollment by Age

Use VHA Resources National data allows comparison of sample with those not in sample Site data allows comparison with those not enrolled VA Informatics community including fellowship

VA CT Informatics Fellowship Co Directors: Cynthia Brandt and Amy Justice Post doctoral fellowship Must be US Citizen 2 years In collaboration with Yale National Library of Medicine Informatics Fellowship Contact: cynthia.brandt@yale.edu

Data Validation HIV diagnosis Comorbidity/AIDS Diagnostic groupings Against Immunology Case Registry Report Fultz SL, et al. Development and verification of a “virtual” cohort using the national VA health information system. Med Care 2006;44(Suppl 2):S25-S30 Comorbidity/AIDS Diagnostic groupings Against a full, manual, structured chart review Justice AC, et al. Medical disease and alcohol use among veterans with human immunodeficiency infection. Med Care 2006;44(Suppl 2):S52-S60. EMR based performance measures Against External Peer Review Program Goulet JL, et al. Measuring performance directly using the veterans health administration electronic medical record. Med Care 2007, 45(1):73-79 Pharmacy fill data Against provider and patient report of active medications In preparation

Pilot Intervention Work Symptom Management (Tsevat) Alcohol use Brief intervention via computer (Conigliaro, VA) Peer led intervention (Justice/Pappas, Kenya)

Other Informatics Projects Text processing Computer interfaces for self report Patient safety monitoring (drug toxicity) Health status of OIF/OEF veterans

Intervention Plans Identify groups of conditions that commonly co-occur E.g., alcohol, drug, cigarette use and depression Use Markov Modeling to develop a combined strategy for prioritizing care incorporating: Risk/benefit Costs Patient preferences Use EMR to support the intervention Identifying subjects Collecting additional information Implementing intervention Measuring outcomes

Publications 2006-07 Crothers K, Goulet JL, Rodriguez-Barradas M, Gilbert C, Butt A, Braithwaite RS, Peck R, Justice AC.  Decreased awareness of current smoking among health care providers of HIV-positive compared to HIV-negative veterans.  J Gen Intern Med (in press). Butt AA, Justice AC, Skanderson M, Rigsby MO, Good CB, Kwoh CQ. Rate and predictors of treatment prescription for hepatitis C. Gut 2007, 000: 1-6. Braithwaite RS, Roberts MS, Justice AC.  Incorporating quality of evidence into decision analytic modeling.  Ann of Intern Med, 2007:  146:  133-141.  Gange SJ, Kitahata MM, Saag MS, Bangsberg DR., Bosch RJ, Brooks JT, Calzavara L, Justice AC, et al.  Cohort Profile:  The north American AIDS Cohort Collaboration on Research and Design (NA-ACCORD).  Int J Epidemiol (in press). Goulet JL, Erdos J, Kancir S, Levin FL, Wright SM, Daniels SM, Nilan L, Justice AC.  Measuring performance directly using the veterans health administration electronic medical record.  Med Care 2007, 45(1):73-79. Justice AC.  Prioritizing primary care in HIV:  comorbidity, toxicity, and demography.  Topics in HIV Med 2006; 14(5): 159-163. Cotton S, Puchalski CM, Sherman SN, Mrus JM, Peterman AH, Feinberg J, Pargament KI, Justice AC, Leonard AC, Tsevat J.  Spirituality and religion in patients with HIV/AIDS.  J Gen Intern Med 2006;21:S5-S13. Mrus JM, Leonard AC, Yi MS, Sherman SN, Fultz S, Justice AC, Tsevat J.  Health-related quality of life in veterans and non-veterans with HIV/AIDS.  J Gen Intern Med 2006;21:S39-S47. Braithwaite RS, Shechter S, Roberts MS, Schefer A, Bangsberg DR, Harrigan PR, Justice AC.  Explaining variability in the relationship between antiretroviral adherence and HIV accumulation.  J Antimicrob Chemother 2006;58:1036-1043. McGinnis KA, Fultz SL, Skanderson M, Conigliaro J, Bryant K, Justice AC.  Hepatocellular carcinoma and non-hodgkin’s lymphoma: the roles of HIV, hepatitis C infection, and alcohol abuse.  J Clin Oncol 2006;24(31):5005-5009. Crothers K, Butt AA, Gibert CL, Rodriguez-Barradas MC, Crystal S and Justice AC, for the VACS 5 Project Team.  Increased COPD among HIV-positive compared to HIV-negative veterans.  Chest 2006; 130: 1326-1333. Oursler KK, Goulet J, Leaf D, Akingicil A, Katzel L, Justice AC, Crystal S.  Association of comorbidity with physical disability in older HIV-infected adults: the veterans aging cohort five-site study.  AIDS Patient Care and STD 2006;20(11):782-791.

13. Diero L, Kimaiyo S, Siika AM, Shaffer D, Rotich JK, Smith FE, Mamlin JJ, Einterz R, Jusicd AC, Carter EJ, Tierney WM.  Characteristics of patients with HIV infection. East Afr Med J 2006;93(8):424-433. 14. Butt AA, Justice AC, Skanderson M, Good C, Kwoh CK.  Rate and predictors of hepatitis C virus treatment in HCV-HIV –coinfected subjects.  Aliment Pharmacol Ther 2006;24(4):585-591. 15. May MT, Sterne JAC, Costagliola D, Sabin CA, Phillips AN, Justice AC, Dabis F, Gill J, Lundgren J, Hogg RS, de Wolf F, Fätkenheuer G, Staszewski S, d’Arminio Monforte A, Egger M.  HIV treatment response and prognosis in Europe and North America in the first decade of highly active antiretroviral therapy: a collaborative analysis.  Lancet 2006;368(9534):451-458. 16. Conigliaro J, Justice AC, Gordon AJ, Bryant K; VACS Alcohol and Behavior Change Research Group.  Role of alcohol in determining human immunodeficiency virus (HIV)-relevant outcomes: a conceptual model to guide the implementation of evidence-based interventions into practice.  Med Care 2006;44(Suppl 2):S1-S6. 17. Justice AC, Erdos J, Brandt C, Conigliaro J, Tierney W, Bryant K.  The Veterans Affairs Healthcare System: a unique laboratory for observational and interventional research.  Med Car 2006;44(Suppl 2):S7-S12). 18. Justice AC, Dombrowski E, Conigliaro J, Fultz SL, Gibson D, Madenwald T, Goulet J, Simberkoff M, Butt AA, Rimland D, Rodriguez-Barradas MC, Gibert CL, Oursler KAK, Brown S, Leaf DA, Goetz MB, Bryant K.  Veterans aging cohort study (VACS): overview and description.  Med Care 2006:44(Suppl 2):S13-S24. 19. Fultz SL, Skanderson M, Mole LA, Gandhi N, Bryant K, Crystal S, Justice AC.  Development and verification of a “virtual” cohort using the national VA health information system.  Med Care 2006;44(Suppl 2):S25-S30. 20. Cook RL, McGinnis KA, Kraemer KL, Gordon AJ, Conigliaro J, Maisto SA, Samet JH, Crystal S, Rimland D, Bryant KJ, Braithwaite RS, Justice AC.  Intoxication before intercourse and risky sexual behavior in male veterans with and without human immunodeficiency virus infection.  Med Care 2006;44(Suppl 2):S31-S36. 21. Gordon AJ, McGinnis KA, Conigliaro J, Rodriguez-Barradas MC, Rabeneck L, Justice AC, for the VACS-3 Project Team.  Associations between alcohol use and homelessness with healthcare utilization among HIV infected veterans.  Med Care 2006;44(Suppl 2):S37-S43. 22. Kraemer KL , McGinnis KA, Skanderson M, Cook R, Gordon A, Conigliaro J, Shen Y, Fiellin DA, Justice AC.  Alcohol problems and health care services use in human immunodeficiency virus (HIV)-infected and HIV-uninfected veterans.  Med Care 2006;44(Suppl 2):S44-S51. 23. Justice AC, Lasky E, McGinnis KA, Skanderson M, Conigliaro J, Fultz SL, Crothers K, Rabeneck L, Rodriguez-Barradas M, Weissman S, Bryant K, for the VACS 3 Project Team.  Medical disease and alcohol use among veterans with human immunodeficiency infection.  Med Care 2006;44(Suppl 2):S52-S60. 24. Butt AA, Justice AC, Skanderson M, Good C, Kwoh CK.  Rates and predictors of hepatitis C virus treatment in HCV-HIV-coinfected subjects.  Aliment Pharmacol Ther 2006;24(4):585-591. 25. Braitstein P, Justice AC, Bangsberg D, Yip B, Alfonso V, Schechter M, Hogg R, Montaner JSG. Hepatitis C co-infection with HIV is independently associated with decreased adherence to antiretroviral therapy in a population-based HIV cohort.  AIDS 2006;20:323-331.

Related Funding (Interventions*) PI Type Focus of Study Berliner R01 (NHLBI/NIA) Unexplained Anemia in HIV+/- Aging Veterans Braithwaite R21 (NIAAA) Defining the Threshold for Alcohol- Induced Nonadherence in HIV+ Patients Braithwaite K23 (NIAAA) Tailoring HIV therapy to alcohol using populations Butt K23 (NIDA) Treatment Disparities/Outcomes of HCV-HIV Co-Infection Conigliaro* R21 (NIAAA) Alcohol Use & HIV: Developing Computerized Interventions Freiberg K23 (NIAAA) Alcohol and Coronary Heart Disease in People with HIV (Barnett) R01 (NHLBI) Cost-benefit of Smoking Cessation in HIV

Related Funding cont’d PI Type Focus of Study Lim R21 (NIAAA) Markers of Alcohol Toxicity in HIV-infected Veterans Justice U10 (NIAAA) Alcohol Associated Outcomes Among HIV+/- Veterans Justice (Papas)* R21 (NIAAA) Alcohol & HIV in Kenya: Stage 1 Trial of a Peer-led Alcohol Behavior Intervention Oursler K23 (NIA) Aging and Physical Functioning in HIV Tsevat* VA HSR&D Implementing Symptom Assessment into Clinical HIV Care Lore K23 (NIAID) Risk Factors and Prediction of Liver Disease in HIV/HCV

It Takes a Village…

Acknowledgements PI and Co-PI: AC Justice, DA Fiellin Participating VA Medical Centers: Atlanta (D. Rimland, C Jones-Taylor), Baltimore (KA Oursler, R Titanji), Bronx (S Brown, S Garrison), Houston (M Rodriguez-Barradas, N Masozera), Los Angeles (M Goetz, D Leaf), Manhattan-Brooklyn (M Simberkoff, D Blumenthal, J Leung), Pittsburgh (A Butt, E Hoffman), and Washington DC (C Gibert, R Peck) Core Faculty: S Braithwaite, C Brandt, K Bryant, R Cook, J Conigliaro, K Crothers, J Chang, S Crystal, N Day, J Erdos, M Freiberg, M Kozal, M Gaziano, M Gerschenson, B Good, A Gordon, J Goulet, M Hernan, N Kim, K Kraemer, J Lim, S Maisto, K Mattocks, P Miller, L Mole, P O’Connor, R Papas, H Paek, J Robins, C Rinaldo, M Roberts, J Samet, B Tierney, J Whittle Staff: D Cohen, A Consorte, D Gibson, K Gordon, F Kidwai, F Levin, K McGinnis, M Rambo, J Rogers, M Skanderson, F Whitsett Major Collaborators: Immunology Case Registry, Pharmacy Benefits Management, Framingham Heart Study, Women’s Interagency HIV Study, Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC), Health Economics Research Center (HERC), Center for Health Equity Research and Promotion (CHERP) Funded by: National Institute on Alcohol Abuse and Alcoholism (2U10 AA 13566); National Institute on Aging (K23 G00826); Robert Wood Johnson Generalist Faculty Scholar Award; an Inter-Agency Agreement between National Institute on Aging, National Institute of Mental Health, and the Veterans Health Administration; the VHA Office of Research and Development; and, VHA Public Health Strategic Health Care Group.