HCV in Veterans Administration (VA)
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1 HCV in Veterans Administration (VA) Timothy Morgan, MD, Rachel Gonzalez, MPH, Angela Park, PharmD, Pam S. Belperio, PharmD, Bill Lukesh, Kristine Desotto, Tim Schmoke, Maggie Chartier, PhD, David Ross, MD, PhD, and the HIT s HIV, Hepatitis and Related Conditions, Office of Patient Care Services IVHEM, Amsterdam, 8 December 2018
2 Disclosures Clinical trials: AbbVie, Bristol-Myers Squibb, Genfit, Gilead, and Merck 2
3 VA Structure 8.9 million Veterans enrolled in VA care 18 regions called Veteran Integrated Service Networks (VISNs) 151 VA Medical Centers (VAMCs), with 6-8 per VISN Approximately 1000 community-based outpatient clinics (CBOCs) HCV recognized as a priority by VA leadership VA is the largest single provider of HCV care in the United States 3
4 HCV in VA: A Brief History 1998: Under Secretary for Health issues information letter all Veterans will be assessed for HCV risk factors and, if positive, tested for HCV Ab 1998: Hepatitis Screening day: 6.6% of 26, : VA Directive Mandatory initiation of risk-based HCV clinical reminders 2000: VA requests $195 million for HCV screening 2001: VA requests $340 million for HCV treatment 2001: GAO: VA needs to improve HCV screening and testing 2001: National Hepatitis C Program in Office of Public Health Creation of Hepatitis C Resource Centers HCV Clinical Case Registry 2003: GAO: VA needs to improve notification of Veterans of positive HCV results 2009: Reflex HCV RNA testing if HCV antibody is positive (same blood specimen)
5 Hepatitis Innovation Teams Structure and function VACO Hospital-based multidisciplinary teams of MD, NP, RN, clerks, system redesign Write annual process improvement projects National Leadership Team provides guidance and monthly virtual meetings HITs exchange best practices, status of improvement projects, and goals HHPHP Collaborative Leadership Team VISN HIT Leads Focused working groups Constant communication between Leadership Team and VISN HITs HIT medical centers 5
6 HCV Innovation Teams (HIT) and Lean: Improve HCV care by redesigning care delivery processes Employ Lean methodology to produce measurable improvements in variability, access, and quality of HCV care Assess how we deliver care now (current state ) Identify problems with care delivery (problem statement) Propose & test solutions (future state & tests of change) Measure change in care (monitoring and evaluation) Assess improvements 6
7 Patients with HCV System Redesign Why system redesign? 2000 Facility Liver Clinic <100 <125 <150 >3.25 <3.25 Platelet Count FIB-4 Treatments are not effective if patients don t receive them 7
8 Current State (2013) VA Long Beach Patient completes Hep C education class Provider completes risk assessment Patient tests positive
9 Sustain Change Team/Aim Sustain Change Map/Measure Sustain Change Map/Measure Title: VISN 18 HIT Aim #1 Screening the Birth Cohort for HCV VISN 18 Winston Evans Project Manager: Melinda Russell Start Date: March 2015 Owner: Project Leader: Ronald Schifman, MD Tucson Team Members: Cindy Barger, Danny Luevano SR Lead: Teresa Cox Updated on: 1/18/ Reasons for Action: 4. Gap Analysis: 7. Implementation / Completion Plans: Problem Statement: In the United States, the prevalence of chronic HCV infection is approximately 1.3%, but double that among Veterans and 8.9% among birth cohort Veterans in the VA system during CY Recent guidelines for HCV screening include universal testing for all individuals born between 1945 and As of November 2014, 191,136 enrolled patients in VISN 18 are in this age range and 131,036 (68.56%) have been tested for HCV. The remaining 60,100 remain untested, of which 36,000 had appointments within the past 12 months. New treatment options for chronic HCV infection have less severe side effects and better long term outcomes. As a result, more patients may benefit from seeking care for VISN 18 HIT Aim #1 BC Screening Aim 1: Increase VISN 18 HCV screening rate of birth cohort FY 15 FY 16 FY 17 FY 18 FY 19 Veterans ( ) from 71% 73% 75% 78% 70% to greater than 80% by 80% the end FY19. In Scope: Veterans born between 1945 and 1965, Start: Identify each Veteran in seen in VISN 18 in past 2 years, without one time BC not screened screening in CDW Stop: Notify Veteran of Out of Scope: Veterans with death record, screening result and follow-up Veterans with bad address flags for new cases A3 2. Current State: 5. Countermeasures / Solution Approach: Current SAVAHCS State: Hepatitis C Virus Screening Current State Process Map Value added Non-value added but necessary Non-value added Gap Analysis IfWe: Then we expect: 8. Confirmed State: A3 Encounter with PACT or Admin Med HCV Ab test performed Result entered in Vista HCV Ab Result HCV Screen ordered? YES Historical data not checked Duplicate tests Referred to GI in Error Large pool unconfirmed POS Molecular Dept. performs a Historical search for HCV Viral Load testing YES Blood draw within 6 months? Viral Load testing performed NO Historical result in chart? NEG YES NEG NO NO Result entered in Vista Historical HCV Viral Load Result Order too old Lost to Testing Process variability Provider reviews results POS No viral load testing is performed Liver Disease? NO Lost to HCV Testing progresses YES GI consult Remains Untested Remains Untreated placed PCP orders liver enzymes, Ultrasound NOT Referred to GI in Error Patient notified of positive viral POS HCV Viral Load load Result NEG SVR or Antibody false positive Known history of positive viral load How is patient notified? Treatment HCV Ab history unclear Negative 3. Target State: Tucson Program Developer queries CDW for birth cohort not screened but eligible Test Result POS Chief, Diagnostics calls/ s provider to offer referral to GI. NEG SAVAHCS Hepatitis C Screening Future Map Tucson Program Developer applies the PACT Provider preferences to query (option, letter, number sent per month) Confirmatory Test (HCV Viral Load) POS Tucson Program Developer creates a progress note, auto signs Pat ch = R1AC PRI NT POSTCARD 4. 0 Test Result NEG Negative Result letter sent to Veteran Provider notifies Veteran or patient contacts provider Phase 1 PACT Screening TIU triggers letter to be sent from Sacramento HCV antibody testing performed Chief, Diagnostics monitors follow-up (note in CPRS that result was discussed with patient) until complete. Veteran Receives Letter Blood collected (two serum tubes) Veteran presents to Lab? YES Veteran brings letter or requests test YES Lab places order Screening Complete NO NO Veteran remains Unscreened Veteran remains Unscreened Tool for Non-Lab Staff Phlebotomy: Instructions with visual cues "What Right Looks Like" 6. Rapid Experiments: Rapid Experiments Plan: Write SQL code to develop registry of untested Design testing options and letter templates Enlist one PAC Teamlet Run SQL code and validate registry of untested Select options and letter and number of letters per month Do: Activate notifications Send 50% letters and measure response. 90 days later send remainder of letters. Study: Monitor screening in patients notified versus those that are not Act: Adjust options and number as needed based on results Enlist entire PACT, facility, VISN facilities Only one positive test result in pilot study 9. Insights: Current state maps can open eyes for the need to improve and embrace a team solution Difficult to engage team members with treatment funding uncertainty Reassure team, no matter the political climate, do what is right for the Veteran Technology and tech experts, make this project easy to implement Difficult to engage a VISN team for a four year project when our VISN is being redistributed Automated Letter process is virtually transparent to Providers (no work) Universal screening of the Birth Cohort as recommended by the CDC in this project pilot yielded <1% incidence of positive test results Prior study screening high risk BC patients yielded a 16% incidence of positive test results (see below). 9
10 Data and Metrics National Metrics: Leading measure: screening Leading measure: treatment starts Leading measure: SVR documented Lagging measure: HCV cured Annual goals Data HCV screening rates (quarterly) HCV starts (monthly) SVR testing rates (monthly) 10
11 HCV Dashboards Providers have real-time access to patient data HCV dashboard committee: Karine Rozenberg, Janice Taylor, Linda Chia, Amy Hirsch, Andrew Himsel, Andrew Jacob
12 HCV Testing: Interventions 1) Clinical Reminder for Primary Care in ehr : risk-based screening 2014 present: birth cohort and risk based 2) Reflex HCV RNA testing if HCV Ab positive 3) Performance measure for Healthcare Executives 4) Multimedia Marketing (print, social media, VSOs) 5) Focus on at-risk groups by educating and partnering with: Mental Health & Substance Use Tx Providers Homeless stand-downs HUD-VASH (Veterans Affairs Supportive Housing) 12
13 Expanding HCV Care Beyond Specialty Providers Face to face Shared medical appointments Telephone Clinical video telehealth (CVT) VA-ECHO Electronic Consult based systems (e consult) PharmD, Nurse Practitioner Primary Care VA CPPO Role of Clinical Pharmacy Specialist Fact Sheet, June 2016 Remotely /another site Expanding Access to HCV Treatment Same site Provider: MD, NP/PA PharmD, Home Primary Care
14 VA s Hepatitis C Treatment Considerations: Remove restrictions for HCV treatment All patients with chronic HCV who do not have medical contraindications are potential candidates for antiviral treatment. Substance use: Not an automatic exclusion Liver fibrosis: No restrictions All HCV antivirals available on formulary No pre-authorization Criteria for Use to define appropriate therapy 14
15 % of Birth Cohort Veterans Tested HCV Birth Cohort Testing in VA 100,0% 80,0% 60,0% 65,8% 68,8% 73,9% 80,1% 84,3% 40,0% 20,0% 0,0% Oct Sept 2014 Oct Sept 2015 Oct Sept 2016 Oct Sept 2017 Oct Sept 2018 Born HCV tested Percent tested 65,8% 68,8% 73,9% 80,1% 84,3% Source: CDW prepared by Population Health Services (10P4V) 15
16 HCV (DAA) Treatment Cumulative VA Population Health 10P4V 16
17 Number of Veterans with HCV in VA Care, requiring HCV antiviral treatment HCV persistence likely for many years VA Population Health 10P4V 17
18 Veterans Starting Treatment
19 Cascade of HCV Care in VA 19 Population Health Service 10P4V; Data through 31 December 2017
20 Lessons learned: National All patients PharmD, NP ECHO Group Clinics Drug price Expand Treaters $$$ Leadership Support VACO, VSO Congress Leading, lagging Annual goals Monitor progress Metrics Goals Cure Teams & Leaders Multidisciplinary Hospital-based Communications SharePoint Monthly calls Education Screening, treatment, SVR Dashboard Monthly data reports to HITs Data System Redesign VERC Annual VISN HIT A3 Share Best Practices Implementation Strategies 20
21 VA Viral Hepatitis Progress through 9/2018: Key Points 84.3% of Veterans in care in the birth cohort have been screened for HCV 15,500 estimated undiagnosed in VA care. (>90% diagnosed) 112,986 Veterans have been treated with all-oral DAAs <30,000 known viremic Veterans. Enriched with MH/SUD, housing, distance, co-morbidities, unwillingness, etc. 21
22 Thanks to the Hepatitis C HIT teams (a few shown here) 22
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