BACKGROUND/RATIONALE:
With the advent of direct acting agents (DAAs) for Hepatitis C Viral (HCV) infection, the probability of cure may be higher (~70%), the duration of treatment may be half as long for some patients, but the side-effect burden will be significantly greater than the current standard. DAA treatment also puts stringent demands for adherence to a more complicated regimen. Thus, although the treatment may be more effective, decisions will remain (and perhaps become more) challenging. Our overarching goal is to develop and implement an evidence-based shared decision making aid in HCV. As a first (preparatory) step, we proposed a well-defined qualitative study to examine what factors HCV providers and patients consider while making treatment decisions, and to elicit their perceptions related to the decision process.

OBJECTIVE(S):
Aim 1: Conduct semi-structured interviews with HCV providers and HCV patients to identify what information they perceive as important to make treatment decisions, understand how best to communicate this information, determine the preferred mode and timing of information presentation, and clarify patient values as they relate to HCV treatment. Aim 2: Convene an advisory panel of key stakeholders to review the qualitative findings, discuss a draft decision-making aid, and advise on implementation elements necessary for a successful decision-making process in HCV treatment.

METHODS:
To achieve Aim 1, we conducted in-depth qualitative interviews with a) HCV clinicians, b) HCV patients who were contemplating DAA treatment, c) patients who had declined treatment, and d) patients who had started DAA treatment. Responses from the 3 patient groups provided complementary insight into the factors that patients consider in making treatment decisions as well as the perceived barriers to and facilitators of shared decision-making. The systematic comparison of patients' and their providers' accounts, both within and between groups, highlighted discrepancies and therefore areas where increased decision support may be needed. Our approach was to let these interviews guide the content and format of the decision aid. To achieve Aim 2, we convened an Advisory Panel of stakeholders in HCV treatment to review results from Aim 1 and to discuss implementation elements necessary for a successful decision-making process in HCV.

FINDINGS/RESULTS:
Aim 1: Qualitative interview data from 7 HCV providers and 29 HCV patients (21 male; 8 female) from 4 diverse VA Medical Centers (Houston, St. Louis, Los Angeles, Little Rock) was analyzed using Atlas.ti software. Results revealed that HCV clinicians consider a common set of factors when deciding if a patient is a good candidate for treatment. Most considered substance abuse history, mental health history, liver status, co-morbidities, patient willingness, and social stability (living situation, available support). Many also considered the promise of new treatments expected to become available in the near future. Providers endorsed the need for all factors to be considered together. Among providers who indicated a single most important factor, all named patient willingness to be treated. When deciding to recommend immediate treatment versus delaying treatment, providers considered the same factors as above, with increased emphasis on stage of liver damage (cirrhosis).

Analysis of patient interview data) revealed that patients considered 39 unique factors (mean=8; range, 5-13) as important during the HCV treatment decision-making process. The two most commonly noted factors were physical side-effects of treatment (n=24) and treatment efficacy (n=23). Other commonly noted factors included availability of new medications on the horizon (n=16), psychological side-effects (n=16), underlying status of liver disease (n=15), complexity of treatment regimen (n=12), family and friend support network (n=12), and other illnesses (n=12). Multiple factors were interrelated in highly complex ways. These data were used to develop the value clarification component of a shared decision-making aid prototype.

Aim 2: An advisory panel of 12 clinicians, research scientists, and other key stakeholders met to discuss qualitative interview results, make recommendations on the design of the decision aid prototype, as well as recommend next steps for future research. The group agreed that the development of a shared decision-making aid for HCV is important (as none exists at this time) despite the rapidly changing HCV treatment paradigm (new medications with fewer side-effects emerging yearly). The panel felt that in addition to eliciting and clarifying patient values regarding antiviral treatment, the decision aid can also serve as an educational tool to re-enforce verbal information given to the patient during the HCV clinical visit. Recommendations for next steps included: 1) modifying the prototype decision aid to include both interferon-based and interferon-sparing treatment regimens; 2) including more information on cirrhosis progression; 3) obtaining feedback via cognitive interviews on the prototype from a few HCV patients; 4) modifying the prototype based on patient feedback. The panel also made recommendations regarding the implementation elements necessary for a successful decision-making process in HCV.

IMPACT:
Chronic infection with Hepatitis C Virus (HCV) is a common condition. Treatment with interferon and ribavirin reduces liver disease progression and improves survival. However, the decision to start treatment is difficult. The trade-offs that patients face include a modest probability of cure (~50%) and a high probability of side-effects for up to 48 weeks. Providers also consider patients' comorbidities and motivation to adhere to a difficult treatment course. Given this, not many Veterans with HCV receive treatment. Results from this study will lead to the development of a decision-making aid to help HCV patients and providers with these difficult decisions and thus ultimately help realize the benefits of antiviral treatment.

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External Links for this Project

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PUBLICATIONS:

Journal Articles

1. Zuchowski JL, Hamilton AB, Pyne JM, Clark JA, Naik AD, Smith DL, Kanwal F. Qualitative analysis of patient-centered decision attributes associated with initiating hepatitis C treatment. BMC gastroenterology. 2015 Oct 1; 15:124. [view]

Conference Presentations

1. Zuchowski J, Hamilton AB, Pyne J, Clark J, Smith D, Kanwal F. Gender differences in treatment decision-making among Veterans with hepatitis C. Poster session presented at: VA HSR&D Enhancing Partnerships for Research and Care of Women Veterans Conference; 2014 Jul 31; Arlington, VA. [view]
2. Sansgiry S, Pyne J, Smith D, Brown AC, Hodges D, Stanley R, Kanwal F. Health-related quality of life in chronic hepatitis C patients with depression. Poster session presented at: International Society for Pharmacoeconomics and Outcomes Research Annual Meeting; 2014 Jun 3; Montreal, Canada. [view]
3. Natarajan Y, Shukla R, Tansel A, Qureshi Z, El-Serag HB, Kanwal F. Primary Biliary Cirrhosis and the Incidence of Hepatocellular Carcinoma: A Systematic Review. Poster session presented at: American College of Gastroenterology Annual Meeting; 2015 Oct 14; Honolulu, HI. [view]

DRA: Infectious Diseases
DRE: Prognosis
Keywords: none
MeSH Terms: none