Year of Publication

2017

College

Public Health

Degree Name

Dr. of Public Health (Dr.P.H.)

Committee Chair

James W. Holsinger, Jr., MD, PhD

Committee Member

Cezar Brian Mamaril, PhD

Committee Member

Jens Rosenau, MD

Abstract

Introduction. Hepatitis C virus (HCV) is the most prevalent blood borne infection in the United States and its chronic infection has a high burden on the American healthcare system. Since 2014, the all-oral Directly Acting Antiviral (DAA)-based therapy has been established as the standardized curative treatment for HCV with unprecedented high effectiveness and tolerability. Nevertheless, there is a significant gap between the promise from DAAs benefits and the treatment initiation rates in the United States and Kentucky.

Objectives. The goal of this study is to improve the access to the all-oral DAA-based treatment among HCV patients seeking outpatient treatment services at the Kentucky Clinic.

Methods. This study was conducted from October to December 2016 in the specialized HCV outpatient clinic at the Kentucky Clinic in Fayette County, Lexington, Kentucky. The study utilized a mixed methods approach to address the barriers for initiating HCV treatment. The qualitative analysis explored the current model of care applied to the patients seeking HCV treatment, its tools included: field observations, semi-structured in-depth interviews with healthcare personnel providing administrative and clinical services to HCV patients, and review of relevant administrative forms. The quantitative analysis followed a retrospective cohort design including all chronic HCV patients who had their first visit to the Kentucky Clinic between July 1, 2014 and June 30, 2015. The observation time for this cohort was calculated from the first visit until treatment initiation or the last day of observation November 30, 2016. To assess the predictors for treatment initiation, we assessed the sociodemographic, clinical, and behavioral variables of the study cohort. Quantitative analysis included descriptive analysis of the patients’ explanatory variables comparing those who initiated treatment to those who did not followed by time to treatment analysis for: assessing the cumulative incidence of treatment initiation, constructing Kaplan–Meier time to treatment curves estimating the proportion of patients who initiated treatment at different time points comparing each explanatory variable levels, and identifying the predictive independent variables for treatment initiation over time using Cox Proportional Hazards Regression analysis.

Results. Multiple interrelated difficulties in accessing the DAAs treatment were found of relevance to the current model of care and patients’ characteristics. The treatment initiation journey is long and hindered by complicated stepwise administrative and clinical procedures. Lack of proper communication between the referring facility, the scheduling center, and the HCV clinic is obvious. Lack of awareness among the patients and their referring provider concerning the treatment initiation procedures add to the difficulty in communication. In general, the HCV treatment services are broken and not properly connected with other services needed by HCV patients. The administrative and clinical procedures are centered around the PA requirements and Medicaid applied restrictive criteria favoring advanced liver disease patients which requires a clinical proof difficult to achieve in border line cases between the mild and advanced liver disease stages. The quantitative results showed that a total of 880 HCV patients visited the HCV clinic at the Kentucky Clinic between July 1, 2014 and June 30, 2015. Only 195 (22.16%) patients initiated the DAAs treatment during the observation period. Time to treatment initiation results are consistent with the long waiting time found in the model of care results. The average number of days to initiate treatment was 263.57 days. Univariate analysis using Kaplan-Meier time to treatment initiation estimates showed significant earlier treatment among males, African Americans, patients who followed-up at least once, and patients without a history of substance abuse. The disproportionate treatment initiation achievement among the patients born before 1965 was inconsistent under Medicaid coverage and with mild liver disease; patients showed significantly later treatment initiation at different points of time. Bivariate analysis of insurance and liver disease condition showed that Medicaid patients with mild liver disease had the lowest chance for treatment initiation at different time points compared to other groups. The cox model significance results confirmed the previous results on age group, insurance type, and liver disease condition. Medicare baby boomers have almost double and more than quadruple the likelihood of Medicaid baby boomers to initiate treatment at advanced and mild liver disease stages respectively. This likelihood jumps to five and thirteen times respectively on comparing patients born after 1965 with the same characteristics. Likewise, Medicaid baby boomers have less than half the likelihood of private and other insurance patients to initiate treatment at either disease stages. In parallel, the Medicaid patients born after 1965 have nearly quarter the likelihood of private and other insurance patients to initiate treatment at either disease stage. The only significant likelihood difference between Medicare and private and other types of insurance was found among mild liver disease patients born after 1965 where the former group are three times as likely as the latter group to initiate treatment.

Conclusion. Access to HCV treatment in the Kentucky Clinic is hindered by a variety of barriers revolving mainly around the model of care, which is greatly influenced by the insurance system. Structural adjustment for the current model of care and prioritizing the disproportionately affected groups of patients by HCV infection is urgently needed. This study proposes a patient centered comprehensive model of care fostering a patient navigation system providing: early linkage and continuity of care, patient education based on a baseline needs assessment, and awareness for the referring provider about the treatment process. In addition, administrative support is mandatory to speed up the process utilizing data linkage with other healthcare facilities and a special prior authorization support system. Integration of HCV services with other services including primary care, substance abuse management, and other social services. Prioritization should consider Medicaid young patients living in southeast Kentucky with mild liver disease and practicing injection drug use. HCV treatment task shifting to primary providers in the southeastern Appalachian counties is key solution on the long term.

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