Recognize VACS Sites

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Recognize VACS Sites
Atlanta Rimland D., Jones-Taylor C. Baltimore
Oursler KA., Titanji R. Bronx Brown S.,
Garrison S. Houston Rodriguez-Barradas
M.,Masozera N. Los Angeles Goetz M., Leaf
D. Manhattan/Brooklyn Simberkoff M., Leung J,
Blumenthal D. Pittsburgh Butt A., Hoffman
E. Washington, DC Gibert C., Peck R.
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Database Update

• Build 1 Complete
• Build 2 Underway
• Update site data
• Update patient lists (VC and VACS)
• Build 3 in Planning
• Create web interface for counts

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Intervention Plans

• Pilots covered separately

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Long Term Goal

• Use the VA as a laboratory to develop and
• test innovative interventions to optimize care
  of chronic diseasestart with HIV infection

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VACS Approach to Intervention

• Use observational data to design intervention
• Characterize population
• Identify modifiable mediators of outcomes
• Study inter-relationships among mediators
• Inform power calculations
• Event rates
• Effect size
• Large multi-level, multi-modal, strategy trials
• Translational research
• Integrated into VA healthcare
• Built from evidence based components
• Focused on easily identified groups at increased
  risk
• Individually tailored
• Randomized at the clinic level

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Compared to Uninfected, HIV Infected Veterans
Have

• More prevalent
• Liver disease
• Renal disease
• Pulmonary disease
• Intracranial hemorrhage
• Thrombosis
• Cancer
• Multi-morbidity
• All cause mortality

• Less prevalent (maybe)
• Obesity
• Diabetes
• Hyperlipidemia
• Hypertension
• Cardiovascular disease

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Non AIDS Causes of Death Since 2000
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Liver Disease Causes of Death
Cancer
Vascular Disease
HCV and MI risk
Hepatotoma
Liver Disease
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Markers of Liver Disease

• Most never have liver biopsies
• Noninvasive tests include
• Ultra sound
• Elaborate bench assays
• Ratios of available tests (APRI FIB-4)
• FIB 4 age X AST /(platelets X Sqrt of ALT)
• gt3.25 likely liver fibrosis/cirrhosis
• lt1.45 unlikely liver fibrosis/cirrhosis
• lt1.45 89 Negative Predictive Value

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Alcohol Liver Disease
Percent FIB-4 gt3.25
Lim et al, in preparation
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Multiple, Overlapping Root Causes

• Substance use
• Drugs, ALCOHOL
• Major cause of nonadherence
• Viral hepatitis
• Chronic Hepatitis C and B
• Medication toxicity
• Antiretrovirals (nevaripine, mitochondrially
  toxic D drugs)
• non-HIV medications
• HIV infection
• Chronic inflammation
• Immune compromise coupled with immune
  deregulation

Liver Disease
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Veterans at Risk of Liver Injury

• Fib-4gt1.45
• Outside protected range
• 23 HIV- in VACS
• 42 HIV in VACS
• Rather than focusing on etiology, we focus on
  modifying clinical risk

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The Intervention

• Saving lives by minimizing liver injury among HIV
  infected veterans in care
• Acronym anyone?

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Combined Literature

• Interactive behavior change technology
• Adaptive prevention
• Multiple health behavior change
• Five As assess, advise, agree, assist, arrange
• Motivational interviewing
• Behavioral cognitive therapy
• Pharmacologic treatment

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Key Concepts/Goals

• Concepts
• No level of alcohol consumption safe
• Early detection of risk of liver injury
• Intervention targeted at multiple root causes
• Local expert for pharmacologic treatment
• Long term maintenance critical
• Goals
• Screen for contributing causes
• Empower patient to own behavior and care
• Provide decision support to MD
• Coordination of new and existing services

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Multi Modal Intervention

• EMR to
• Identify those at risk
• Alert for and coordinate existing care options
• Identify liver toxic medications
• Measure processes and outcomes
• Offer decision tools
• Coordinate care
• Health Coach to
• Provide tailored risk education and personalized
  feedback
• Empower patient to ask for care
• Enhance and reflect patients motivations
• Reinforce importance of and problem solve around
  adherence
• Use biomarkers as feedback/motivator

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Intervention Outline

• Subjects HIV infected veterans with FIB-4gt1.45
• Sites to be randomized VACS HIV clinics
• Data collection only, otherwise usual care
• Intervention
• Behavior Targets
• Patient
• Any alcohol use
• ARV adherence below 95
• Provider
• Chronic viral hepatitis treatment
• Liver toxic medications
• Primary outcomes Still being determined

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Health Coach Patient Contacts

• First Contact
• Tailored risk assessment/interpretation/advice
• Means of decreasing risk (adherence, alcohol,
  Hepatitis Rx)
• Targeted advice re discussion with provider
• Medication reconciliation
• Case Management
• Vaccinate for hepatitis A or B if negative and
  not previously done
• 3 additional face to face treatments first month
• Update medication reconciliation, Pill counts
• Barrier identification and problem solving
• Review, encourage, action plan
• FU phone/email/website/chat room at monthly, more
  if needed
• As requested by patient additional face to face
• Final treatment visit at 6 months face to face
• Updated 5As with new behavior, biomarker, and
  medication data

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Alcohol Pharmacotherapy

• Screened for hazardous or worse alcohol
• Referral recommended to provider
• Patient activated to request/accept referral
• Trained alcohol pharmacotherapy doctor
• Can use Naltrexone, Topiramate, or Disulfiram
• (Acomprosate is nonformulary)
• Manages and titrates medications
• Monitors toxicity and outcomes
• May choose to refer to substance use clinic

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Provider Contacts

• Orientation/education re liver injury
• Initial encounter
• Risk assessment
• Very specific recommendations for
• Non-action (irrelevant performance measures)
• Action (echo, treat, refer)
• Medication reconciliation with liver summary (all
  sources)
• Patient receptivity/ requests
• Subsequent contacts
• Alert if risk changes
• Alert if new liver toxic medication
• Additional visits if patient requests them

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MD Relief

• Medication reconciliation
• Performance measure resolution
• Alcohol
• Depression
• Tobacco (partial)
• Turn off screens that dont apply
• Colon cancer

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MD Advice Requests

• Liver riskreduction
• OTC toxic medicationsavoidance
• Any alcohol useabstinence
• Not adherentimprovement

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MD Medication Requests

• SSRIs (or referral)
• If depressed
• Pick ARV active against HBV
• If HBV
• Consider discontinuation of toxic medications
• Treat side effects of ARVs
• If nonadherent

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MD Referral Requests

• Alcohol pharmacotherapy
• If dependent
• Hepatology (HCV Clinic)
• If patient willing
• If no absolute contraindications to treatment
• Mental health (or SSRI Rx)
• If depressed

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Graded Alcohol Treatment

• All receive
• Risk assessment, medication reconciliation
• Patient activation
• Advice to quit drinking (health coach and MD)
• Evaluation for viral hepatitis
• Evaluation of ARV adherence
• Hazardous and above drinkers receive
• Request for pharmacologic treatment
• May also be referred to substance use clinic
• If referred for pharmacologic treatment
• Selection of medications
• Graded dosing
• Continued monitoring

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Primary and Secondary Outcomes
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VACS HIV Demographics
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VACS HIV Substance Use (last 12 months)
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VACS HIV Adherence, Hepatitis, and Liver Toxic
Medications
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VACS Outcomes
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Expected Sample
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Possible Trial Endpoints
Assuming 2/3 of eligible patients in VACS
enroll. Analyses underway to determine these
rates.
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Sites Needed for Trial

• Must randomize by clinic
• ICC probably on the order of 0.016
• Get more power with sites than patients
• We likely need more sites
• How many more, remains to be seen

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Remaining Questions

• Demonstrate that changes in FIB 4 and
• biomarker score are associated with
• Changes in mortality
• Changes in SF 12 PCS
• Power calculation for randomization by clinic
• Need better estimations of the ICC.
• Do we need to add sites?
• Is a two year horizon right?

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Implementation Plan

• This fall/winter
• Estimate expected effect size using VACS
  longitudinal data
• Pilots of Naltrexone, Adherence, Life expectancy
• CDA application for adherence intervention
• Work on computer automation of study components
• LOI to Cooperative Studies/possibly other funders
  as well
• Next spring/summer
• Analyze, report results from pilots
• Launch computerized surveys in VACS full study
• Finalize primary endpoint, sites, subjects, and
  time horizon
• Next fall
• Launch 6 month pilot of full trial

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Veterans Aging Cohort Study

• PI and Co-PI AC Justice, DA Fiellin
• Scientific Officer (NIAAA) K Bryant
• 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 K Mattocks (Deputy Director), 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, K Kraemer, J Lim, S Maisto, P Miller, L
  Mole, P OConnor, R Papas, H Paek, J Robins, C
  Rinaldo, M Roberts, J Samet, B Tierney, J Whittle
• Staff D Cohen, A Consorte, 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, Womens Interagency HIV Study,
  Massachusetts Veterans Epidemiology Research and
  Information Center (MAVERIC), Health Economics
  Research Center (HERC), Center for Health Equity
  Research and Promotion (CHERP), ART-CC, NA-ACCORD
• 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.