BACKGROUND/RATIONALE:
Hepatitis C virus (HCV) infection is an important health problem that results in substantial morbidity and mortality, including cirrhosis, hepatocellular carcinoma and death. HCV poses a major burden within the Veterans Administration (VA), with Veterans being 2.5 times more likely to be infected with HCV as the general population. Current studies show that HCV infection can be cured with therapy in up to 60% of patients. However, only a small percentage of HCV-infected Veterans in the VA Healthcare System initiate antiviral therapy. It is important to increase enrollment into therapy as HCV results in cirrhosis in 20% and death in 10% of cases. Yet the reasons for the low enrollment by Veterans into treatment are poorly understood.

OBJECTIVE(S):
To identify the factors associated with barriers to initiating antiviral therapy, we addressed the following aims: 1) Examine whether patient knowledge of HCV and communication with the referring provider was associated with attendance at an initial Gastroenterology (GI) consultation appointment; 2) Examine whether patient knowledge of HCV and communication with the consulting GI provider was associated with the initiation of HCV treatment; and 3) Examine provider knowledge and attitudes toward antiviral therapy. We also examined the following exploratory aims: (1) Assess the impact of stigmatization on the initiation of therapy; and (2) determine whether racial differences in the initiation of antiviral therapy exist.

METHODS:
This prospective study of Veterans referred to the VA Pittsburgh and Puget Sound GI clinics for an initial HCV consultation used two primary methodologies: (1) Veterans completed structured surveys with items measuring patient knowledge of HCV (Patient Education About Hepatitis C, PEAHC) and patient perception of communication with providers (Medical Interview Satisfaction Scale); and (2) semi-structured interviews analyzed with qualitative techniques exploring barriers to antiviral therapy, knowledge of HCV treatment, and trust in providers. In addition, VA GI and Primary Care providers completed a 10-item survey on attitudes toward patients and their candidacy for HCV antiviral therapy.

FINDINGS/RESULTS:
From December 2006-June 2010, 768 potential subjects met medical eligibility criteria. Of these, 540 (70%) consented to be in the study and 501 (93%) provided interview data. Of the 408 patients (89%) who attended their scheduled GI appointment, 403 (90%) were interviewed post-appointment.

Aim 1: Consistent with the underlying hypothesis, (a) patient's understanding of disease severity as measured by the PEAHC predicted attending the GI appointment (p=0.04); and (b) interview descriptions of communication problems with Primary Care Providers predicted not attending the GI appointment (p=0.004). Multivariable logistic regression analyses also identified age (p=0.02), no college degree (p=0.02), and living alone (p=0.02) as predictors of attendance. Qualitative codes predictive of not attending the GI appointment included: doubting the competence of specialty providers (0.005), describing substance use problems (p=0.02), expressing resistance to treatment (p=0.10), and noting an unstable living situation (p=0.04).

Aim 2: Treatment initiation rates were low, with only 17% of subjects who attended the initial GI appointment and for whom antiviral therapy was medically indicated actually starting treatment. As hypothesized, patient understanding of disease severity as measured by the PEAHC was associated with initiating treatment (p=0.007) and the qualitative code of understanding that treatment led to a lower quality of life was associated with not initiating treatment (p=0.06). In terms of communication with the GI provider, none of the 7% of subjects expressing concerns about comfort with or trust in the GI provider initiated treatment (p=0.06). Multivariable logistic regression analyses also identified African American race (p=0.05) and low (<35K) annual income (p=0.007) as predicting no initiation of treatment.

Aim 3: Data acquisition was delayed by the fact that the local Institutional Review Board (IRB) re-evaluated our right to approach providers and collect identifiable information that would enable us to link providers and patients. The approach was modified and an anonymous HCV Provider Survey was sent via Survey Monkey to 205 VAPHS GI, Mental Health, and Primary Care providers. To date, 18 providers have (8.8%) completed the survey. Thus, findings are preliminary and will be amended once data collection and analysis is completed. At this point with a sample of 18, the majority of providers indicated that they would: (1) recommend antiviral treatment for patients with normal ALT levels (N=12); (2) treat methadone users for HCV infection (N=11); (3) not have reservations about recommending antiviral treatment given its side effects and response rate (N=15); and (4) encourage African Americans to enter treatment despite their lower treatment success rates (N=16). Providers indicated that they would: (1) consider previous medication adherence to be important when deciding to initiate antiviral therapy (N=14); (2) find it futile to treat drinkers with antiviral therapy (N=7); and (3) not treat current intravenous drug users for HCV infection (N=9).

Exploratory Aim I. Although we hypothesized that the stigma associated with HCV would be a barrier to treatment, there was no such evidence. Stigma was seen as a barrier that mostly existed only in the past and for only a small portion of Veterans (2.5%).

Exploratory Aim 2. There were no significant racial differences in patients attending an initial GI appointment. Yet, African Americans who did attend the initial appointment were significantly less likely (p=0.05) to initiate antiviral therapy compared to non-African Americans who attended the initial appointment.

IMPACT:
This study is the first investigation to provide insights into the reasons that the vast majority of potentially eligible Veterans do not initiate medically indicated antiviral therapy for HCV. The project focuses on patient perceptions of HCV treatment, while also exploring the role of provider attitudes toward treatment and patients, thereby providing novel and important information about different factors that contribute to the persistently low treatment rate. The results suggest that future research efforts should be directed towards the development and testing of interventions at the patient and provider levels to address knowledge gaps and improve communication in order to improve treatment rates for HCV infection in the VA.

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External Links for this Project

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PUBLICATIONS:

Journal Articles

1. Rogal SS, Arnold RM, Chapko M, Hanusa BV, Youk A, Switzer GE, Sevick MA, Bayliss NK, Zook CL, Chidi A, Obrosky DS, Zickmund SL. The Patient-Provider Relationship Is Associated with Hepatitis C Treatment Eligibility: A Prospective Mixed-Methods Cohort Study. PLoS ONE. 2016 Feb 22; 11(2):e0148596. [view]

Journal Other

1. Rogal SS, Arnold RM, Chapko MK, Hanusa BH, Youk AO, Switzer GE, Sevick MA, Bayliss NK, Zook CL, Chidi A, Obrosky DS, Zickmund SL. Factors associated with hepatitis C treatment eligibility. [Abstract]. Hepatology. 2014 Oct 1; 60(S1):901A. [view]
2. Beste LA, Straits-Troster K, Zickmund S, Larson M, Chapko M, Dominitz JA. Specialty care and education associated with greater disease-specific knowledge but not satisfaction with care for chronic hepatitis C. [Abstract]. Alimentary pharmacology & therapeutics. 2009 Aug 1; 30(3):275-82. [view]

Conference Presentations

1. Obrosky DS, Burkitt KH, Zickmund SL. A data security framework for research study databases using metadata. Paper presented at: VA HSR&D National Meeting; 2008 Feb 14; Baltimore, MD. [view]
2. Zickmund SL, Chapko ML, Hanusa BV, Youk A, Switzer GE, Sevick MA, Bayliss N, Zook C, Obrosky DS, Arnold RA. Barriers to initiating treatment for hepatitis C: results of a Veteran population. Presented at: American Association for the Study of Liver Diseases Annual Meeting; 2014 Nov 10; Boston, MA. [view]
3. Rogal SS, Youk AO, Chapko MK, Hanusa BH, Arnold RM, Switzer GE, Sevick MA, Bayliss NK, Zook CL, Obrosky DS, Zickmund SL. Factors associated with hepatitis C treatment eligibility. Poster session presented at: American Association for the Study of Liver Diseases Annual Meeting; 2014 Nov 10; Boston, MA. [view]
4. Zickmund SL, Chapko ML, Hanusa BV, Youk A, Switzer GE, Sevick MA, Bayliss N, Zook C, Obrosky DS, Arnold RA. Predictors of attendance at GI to discuss treatment for hepatitis C. Presented at: American Association for the Study of Liver Diseases Annual Meeting; 2014 Nov 10; Boston, MA. [view]
5. Zickmund SL, Hanusa BH, Obrosky DS, Chapko MK, Bayliss NK, Switzer GE, Sevick MA, Zook CL, Mrkva A, Arnold RM. Racial disparities in the initiation of hepatitis C antiviral therapy. Poster session presented at: VA HSR&D / QUERI National Meeting; 2012 Jul 17; National Harbor, MD. [view]
6. Zickmund SL. Racial disparities in treatment for hepatitis C: a longitudinal mixed methods approach. Poster session presented at: National Institutes of Health Science of Eliminating Health Disparities Annual Summit; 2012 Dec 17; National Harbor, MD. [view]
7. Demian N, Mitchell M, Warburton A, Arnold R, Switzer GE, Sevick MA, Bayliss NK, Chapko MK, Zickmund SL. Stigmatization and hepatitis C in a Veteran population: comparisons of substance users and non-substance users. Presented at: American Association for the Study of Liver Diseases Annual Meeting; 2014 Nov 9; Boston, MA. [view]
8. Warburton A, Mitchell MA, Demian N, Arnold RM, Switzer GE, Sevick MA, Bayliss NK, Chapko MK, Zickmund SL. Veterans with hepatitis C report negative experiences communicating with their providers. Presented at: American Association for the Study of Liver Diseases Annual Meeting; 2014 Nov 9; Boston, MA. [view]

DRA: Health Systems Science, Infectious Diseases
DRE: Epidemiology, Treatment - Observational
Keywords: Behavior (patient), Behavior (provider), Communication -- doctor-patient
MeSH Terms: none