Chronic hepatitis C (HCV) is a major healthcare burden among American veterans. Among those with genotype 1 who have been treated with pegylated-interferon and ribavirin, the rate of sustained virologic response (SVR) is only 20%. However, two new protease inhibitor-based combination treatment options are expected to undergo review by the Food and Drug Administration in 2010: 1) pegylated-interferon + ribavirin + telaprevir and 2) pegylated-interferon + ribavirin + boceprevir. Both are associated with increased SVR rates, and both confer an increased risk of toxicity over standard treatment with pegylated-interferon and ribavirin. Treatment options also vary in their duration. Given these trade-offs, the decision of which treatment to initiate (assuming patients are candidates for, and have access to, all three) should ideally depend on the informed patient's choice. There are, however, no proven methods to implement individualized decision planning. The immediate goal of this project is to modify a previously developed HSRD-funded decision support tool to improve patient education and enable patients to construct their treatment preferences for HCV. Two versions of the tool will be created to enable presentation of individualized information to treatment naove patients and nonresponders/relapsers. We will also purposefully recruit a diverse sample of patients to evaluate the effects of ethnicity on patient decision making. These data will help the VA plan for the demand of new HCV treatments. We propose to meet our objectives through the following aims:
Specific Aim 1 : To modify an existing decision support tool for veterans who are candidates for treatment of HCV. The tool will be modified to i) include an interactive, individualized, educational component and assessment of patient knowledge, ii) include a task to elicit patients' conceptualization of HCV, iii) expand the treatment options to enable subjects to construct preferences for the new triple therapy combinations with telaprevir and boceprevir, iv) provide patients with feedback illustrating how their trade-offs translate into specific treatment preferences, and v) enable patients to identify and print out specific concerns they would like to discuss with their physician. In addition, to maximize future uptake, the tool will be developed so that it can be administered to individual patients in the clinic or in a group setting (such as in conjunction with the Hepatitis C Resource Centers' education classes). Two versions of the tool will be created to enable presentation of individualized information to treatment naove patients and nonresponders/relapsers.
Specific Aim 2 : To prepare for an intervention trial by determining the decision support tool's acceptability to VA providers and patients, the feasibility of using the tool in two settings (individual patient and group), and by obtaining preliminary evidence of reliability, validity and efficacy in a pre-post test pilot study.
Specific Aim 3 : To describe patient preferences for new antiviral combination treatment options and to compare preferences between non-Hispanic White, non-Hispanic Black, and Hispanic veterans. These data will help the VA plan for future demand of new HCV treatments. The tool will have three objectives: 1) to educate patients about available treatment options and subsequently verify that they have the minimum required knowledge to make an informed choice, 2) to enable patients to construct their treatment preferences, and 3) to generate a personalized form describing each patient's illness perceptions related to HCV, their treatment preference, the reasons underlying their preferences, and specific concerns they would like to discuss with their provider. These goals adhere to the VA principles of promoting patient centered care, informed consent and patient autonomy, and meet guidelines calling for individualized decision making for patients with mild to moderate liver disease due to HCV. The data generated from this study will support an intervention trial to examine the effects of adding this decision support tool on the quality of care of veterans with HCV. Specifically we hypothesize, that addition of this tool will improve 1) the likelihood of veterans making informed and value concordant choices, 2) the quality of communication between VA providers and veterans considering treatment for HCV, 3) the likelihood of veterans initiating treatment with their predicted choice, 4) adherence with treatment, 5) satisfaction with care, and 6) the proportion of veterans attaining SVR.
Guidelines for treatment of hepatitis C from the National Institutes of Health Consensus Development Conference Panel recommend individualized treatment planning for patients with mild to moderate degrees of inflammation on liver biopsy. There are, however, no proven methods to implement individualized treatment planning. The immediate goal of this project is to modify a previously developed interactive computer-based decision support tool to improve patient education and enable veterans to construct their treatment preferences for hepatitis C. The tool will incorporate two new protease inhibitor-based combination treatments expected to undergo review by the Food and Drug Administration in 2010. The deliverable will be a theory-based, well- balanced, decision support tool to facilitate informed choice and implement individualized treatment planning for veterans with hepatitis C.