Health Services Research & Development

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Hepatitis Awareness Month

May 2016


May is National Hepatitis Awareness Month. "Hepatitis" means inflammation of the liver, and is also the name of a family of viral infections that affect the liver; the most common include Hepatitis A, Hepatitis B, and Hepatitis C. Chronic Hepatitis C infection can last a lifetime and lead to serious liver problems, including cirrhosis (scarring of the liver) or liver cancer. An estimated 3.5 million people in the United States have chronic HCV, and it is of particular concern to VA because approximately 165,000 Veterans are infected.1

Approximately 75% to 85% of people who become infected with the Hepatitis C virus (HCV) develop chronic infection.2,3 Moreover, based on the known hepatitis C virus (HCV) acquisition time (i.e., 1960s to 1980s) and the age of acquisition (i.e., 20 to 40 years) of most infected persons in the United States, the proportion of elderly Americans with CHC is expected to increase over time.4 The standard of care for treating HCV is changing rapidly. Until recently, HCV treatment was based on therapy with interferon and ribavirin, which required weekly injections for 48 weeks. Recently, new antiviral drugs have been developed. Direct antiviral agents (DAA) are more effective, safer, and are better tolerated.2,3

HSR&D Research on Hepatitis

HSR&D funds numerous research studies on issues important to providing optimal health and care for Veterans with hepatitis. For example, HSR&D's Bridging the Care Continuum QUERI program works to improve vulnerable Veterans' use of services across the care continuum, "bridging" the continuum by improving outreach and diagnosis, as well as linkage and engagement with specialty care. This QUERI program is working to expand hepatitis C testing and linkage to care in order to prevent cirrhotic liver disease. Following are descriptions of just a few of the HSR&D-funded studies on hepatitis.

Cost-effective Uses of New Hepatitis C Treatments and Budgetary Impact

Standard two-drug treatments for the hepatitis C virus (HCV) are effective in a limited proportion of patients and can cause substantial side effects. When added to standard treatment, direct-acting antivirals (DAAs) improve success rates, but they're also expensive and can increase rates of serious side effects. VA estimated expenditures for DAAs and associated treatments were estimated to reach one billion dollars in FY2012. In addition, recent studies provide evidence that an individual's Interleukin 28B (IL-28B) genotype predicts response to HCV therapy and may help predict response to therapy. This study sought to characterize the treatment costs and utilization, care patterns, and patient characteristics of Veterans with HCV who are treated in the VA healthcare system. In addition, the study assessed the cost-effectiveness of DAAs and IL 28B genotype testing, and estimated VA budget impact and resource requirements associated with uptake of new treatment strategies. Investigators analyzed VA data for 229,693 Veterans who received pharmacologic treatment for HCV from October 2009 to July 2013. Thus far, findings show:

  • The uptake of direct-acting antivirals (DAAs) boceprevir and telaprevir was rapid, and the number of Veterans initiating treatment approximately doubled in the period after their introduction.
  • While new prescriptions favored boceprevir or telaprevir over standard interferon plus ribavirin therapy, there appeared to still be a strong role for interferon plus ribavirin in treating HCV patients.
  • More than 50,000 Veterans received one or more treatments.
  • Of the study cohort, 6% also were infected with HIV.

Implications: This research has the potential to contribute substantially to the current and future clinical care and policy decisions needed to improve health outcomes for more than 165,000 Veterans living with chronic HCV infections.

Principal Investigator: Doug Owens, MD, MS, is part of the HSR&D Center for Innovation to Implementation (Ci2i) and the VA Palo Alto Healthcare System.

Gidwani , Barnett P, Goldhaber-Fiebert J, et al. Uptake and utilization of directly acting antiviral medications for hepatitis C infection in U.S. Veterans. Journal of Viral Hepatitis. May 1, 2015; 22(5):489-95.

Understanding the Role of Informal Caregivers for Veterans with Hepatitis C

For many years antiviral treatment for hepatitis C virus (HCV) was challenging because of the severe side effects from the interferon-containing medication regimens, the stigma associated with HCV, and high prevalence in vulnerable populations such as persons experiencing substance use disorders and homelessness. While recent dramatic improvements in HCV medications have eliminated most of the side effects, there remains a need to understand how serious chronic diseases are managed in the context of interpersonal relationships in a population that has limited social supports. This study explored, during the era of interferon-containing HCV medication regimens, the caregiving relationships Veterans with HCV have, and whether and how those caregivers contribute to the completion of HCV treatment.

Investigators conducted interviews with Veterans infected with HCV and with their informal caregivers (n=32). For this study, informal caregivers were individuals that knew about the Veteran's hepatitis C, had provided some support for their health and other life issues, and who were not paid for this support. Approximately half of the Veteran-caregiver dyads were marital or intimate partners; the remaining caregivers included friends, siblings, and adult children of the Veterans. All patients were male, while most caregivers were female. Findings show:

  • Emotional interactions were complicated. While many Veteran-caregiver dyads reported increased tension, some also experienced greater closeness and fulfillment. Caregivers' support was appreciated, yet it could also threaten Veterans' feelings of self-sufficiency and independence as they struggled with limitations secondary to side-effects, as well as their commitments to complete treatment.
  • Caregivers provided instrumental support, including:
    • Transportation and assistance with housework and shopping;
    • Emotional support through listening to Veterans' difficulties and providing encouragement; and
    • Informational support by helping Veterans recall and understand medical information given to them at appointments.
  • Caregivers experienced both emotional and logistical burdens. The primary source of burden was Veterans' depression, irritability, and fatigue caused by antiviral therapy. Awareness of the stigma associated with HCV also was present, and several caregivers worried about the future should treatment fail.
  • Caregivers' needs encompassed both informational and emotional support. While some caregivers attended the Veterans' medical appointments regularly, many only received second-hand information from Veterans and wished they knew more so that they could better understand and support them. Also, some caregivers had few sources of their own social support and often felt alone and burdened through the treatment process.

Implications:

Although HCV antiviral treatment has changed, these findings continue to be relevant because many Veterans with HCV have chronic health challenges due to end-stage liver disease, and stigma is still associated with HCV. Supporting these Veteran-caregiver relationships would be beneficial for Veterans' chances of achieving treatment success. Part of this support might entail supporting the informal caregiver with information about HCV and the treatment process on an ongoing basis. It also may entail providing emotional/psychological support to informal caregivers that experience intense anxiety about potential loss if treatment is not successful.

Principal Investigator: Keith McInnes, ScD, MS, is part of HSR&D's Center for Healthcare Organization and Implementation Research (CHOIR) and the Edith Nourse Rogers Memorial Veterans Hospital in Bedford, MA.

Leveraging HIT to Improve Specialty Care Access for Veterans with HCV

In 2012, VA launched a new program known as Specialty Care Access Network - Extension for Community Healthcare Outcomes (SCAN-ECHO) - telehealth technology to help provide specialty, comprehensive care to Veterans nationwide, regardless of where they live. With this program, the specialist team coaches the primary care provider to become a local expert on a specific health condition. This ongoing study aims to compare HCV and liver-related quality of care among Veterans enrolled in SCAN-ECHO sites to those in structurally similar control sites - and to understand the process and content of specialist-generalist consultation process.

In Phase 1 of the study, investigators recorded SCAN-ECHO sessions to understand the collaboration process between specialists and generalists caring for Veterans with HCV. Direct observation established the average duration of patient-case video consultations was 8.5 minutes. Cross-site process differences included: participant attendance frequency, interactional style, interpersonal tenor, presentation and discussion focus, and consultation character. Consultation content results showed that generalists' questions addressed diagnosis and disease-related etiology (38%), treatment concerns (37%), and effective communication (18%), but some consultations had no identifiable question (7%). Process factors, especially attendance frequency and consultation character, may contribute to differences in video consultation content.

In Phase 2 of the study, a quantitative analysis was performed to understand the clinical impact of the program on hepatitis C quality of care at the mentored site and provider level. Since program inception, 2,581 Veterans with HCV have been served by the program. Thus far, finding show:

  • Compared to structurally similar control sites, Veterans with HCV who received care from mentored providers and sites were significantly more likely to receive HCV therapy, hepatitis A and B vaccination, and screening for liver cancer.

Implications:

The live video teleconferencing format of SCAN-ECHO enables rapid (8.5 minutes) per patient case consultation. In addition, provider participation in the program increases the likelihood that Veterans with HCV receiving care at a mentored site are more likely to receive HCV treatment and preventive liver care.

Principal Investigator: Catherine Rongey, MD, MSHS, is part of the San Francisco VA Medical Center.

In addition, VA HSR&D's Quality Enhancement Research Initiative (QUERI) partnered with VA's Office of Specialty Care Transformation to assess the implementation and impacts of four initiatives that include SCAN-ECHO. Findings for SCAN-ECHO showed extremely strong support for the program on the part of providers, but highlighted the need for protected time for primary care providers' participation, as well as the importance of leadership engagement at all stages of implementation.

Care for Women Veterans with Hepatitis C

Most knowledge of chronic hepatitis C (CHC) care within VA is based on studies of men. However, women's healthcare needs differ from men's for several conditions including CHC, and barriers to CHC treatment also are likely to vary by gender. For example, women with CHC have more mental health comorbidities - the leading modifiable barrier to antiviral treatment. In addition, women's care experiences and their perception of VA care are distinct from those of men. This ongoing study will examine gender differences in access to and receipt of CHC care measured by seeing a CHC specialist and receipt of antiviral treatment, respectively. Investigators also will identify predictors of access to and receipt of CHC care, and characterize women's experiences with accessing and receiving CHC treatment in the VA healthcare system. Investigators will use VA data for a national cohort of Veterans with CHC (n>10,000 women and >290,000 men) who were enrolled in VA healthcare during 2002-2014 to examine the effect of gender on these measures. They also will conduct in-depth interviews with women Veterans with CHC at three geographically distinct VA sites who have either not seen a CHC specialist, seen a specialist once but have not completed a clinical evaluation of their CHC, or expressed interest in or received CHC treatment. Responses from these patient groups will provide insight into the factors that patients consider (or potentially should or could have considered) in engaging in CHC care, as well as the perceived barriers to and facilitators of such engagement in quality care from the woman Veterans' perspective.

Implications:

This multifaceted study will help in the development of strategies to provide patient-centered high-quality care to the increasing number of women Veterans with CHC. Findings also will have implications extending beyond CHC, in that it will provide data on the experiences of women Veterans with chronic health conditions not typically managed in the primary care or mental health settings.

Principal Investigator: Fashia Kanwal, MD, MSHS, is part of HSR&D's Center for Innovations in Quality, Effectiveness and Safety (IQuESt) and the Michael E. DeBackey VA Medical Center in Houston, TX.

Web-based Intervention to Reduce Alcohol Use in Veterans with Hepatitis C

Veterans with the hepatitis C virus (HCV) report high rates of current or prior alcohol use disorders. Alcohol consumption is particularly problematic among this population as it can negatively impact eligibility for antiviral therapy and worsen HCV disease progression. Despite abundant data demonstrating effectiveness, person-delivered Brief Alcohol Interventions (BAIs) are not always implemented in HCV clinics due to many potential barriers (e.g., scarce provider time, limited clinic resources, and logistical concerns). This results in a gap in care for many HCV-positive Veterans who would likely experience improved health if they reduced or eliminated their alcohol use. This ongoing study will redesign an existing web-based BAI for use with Veterans with HCV, and assess patient, provider, and system factors that may impact the adoption of this intervention within VA Liver Clinics. Investigators also will implement and examine the effectiveness of the redesigned BAI in Liver Clinics at two VA medical centers, and conduct budget impact analyses. In the first phase of the study, interviews were conducted with 30 Veterans with HCV and 9 Liver Clinic staff members to obtain feedback on the elements of a computer-delivered BAI for the purpose of redesigning this program for use in VA Liver Clinics. After changes were made to the BAI based on this feedback, a second round of interviews was conducted showing that participants responded positively and that they requested no new revisions. The second phase of the study is a randomized clinical trial comparing the computer-delivered BAI to usual care. The trial began in early 2016 and will enroll VA patients through the end of the year.

Implications: Study investigators anticipate that findings will show that web-based BAIs are a feasible, low-cost and effective approach for reducing alcohol consumption in Veterans with HCV, and by extension could be tried in other care settings as well (e.g., surgery). If this web-based BAI is effective, VA's Office of Mental Health Operations, Office of Mental Health Services, and the VA Office of Public Health are interested in implementing this approach across VA medical centers nationally.

Principal Investigator: Keith Humphreys, PhD, is part of the HSR&D Center for Innovation to Implementation (Ci2i) and the VA Palo Alto Healthcare System.

References:

1. Cost-Effective Uses of New Hepatitis C Treatments and their VA Budgetary Impact. HSR&D study IIR 12-059.

2. Hepatitis C. Centers for Disease Control and Prevention (CDC).

3. Hepatitis C. World Health Organization.

4. El-Serag H, Kramer J, Duan Z, and Kanwal, F. Epidemiology and Outcomes of Hepatitis C Infection in Elderly U.S. Veterans. Journal of Viral Hepatitis. April 3, 2016; Epub ahead of print.

Veterans' Resource: