Preparing for New Antivirals: Preferences for Treatment of Hepatitis C

准备新的抗病毒药物：丙型肝炎治疗的偏好

• 批准号: 8529234
• 负责人: Liana Fraenkel
• 金额: --
• 依托单位: VA CONNECTICUT HEALTHCARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-11-01 至 2014-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8529234
• 关键词: Adherence; American; Antiviral Agents; Caring; Chronic Hepatitis C; Clinic; Combined Modality Therapy; Communication; Computers; Consensus Development Conferences; Data; Decision Making; Education; Equilibrium; Ethnic Origin; Feedback; Funding; Future; Genotype; Goals; Guidelines; Healthcare; Hepatitis C; Hepatitis C virus; Hispanics; Individual; Inflammation; Informed Consent; Interferons; Intervention Trial; Knowledge; Liver diseases; Methods; Not Hispanic or Latino; Patient Education; Patient Preferences; Patient-Centered Care; Patients; Physicians; Pilot Projects; Pre-Post Tests; Printing; Protease Inhibitor; Provider; Quality of Care; Recruitment Activity; Resources; Ribavirin; Risk; Sampling; Testing; Toxic effect; Translating; Uncertainty; United States Food and Drug Administration; United States National Institutes of Health; Validity and Reliability; Veterans; base; expectation; illness perceptions; improved; liver biopsy; meetings; preference; response; satisfaction; standard care; theories; tool; treatment planning; uptake

DESCRIPTION (provided by applicant): Project Summary 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.

描述（由申请人提供）： 项目摘要 慢性丙型肝炎 (HCV) 是美国退伍军人的主要医疗负担。在接受聚乙二醇干扰素和利巴韦林治疗的基因1型患者中，持续病毒学应答（SVR）率仅为20%。然而，两种新的基于蛋白酶抑制剂的联合治疗方案预计将在 2010 年接受美国食品和药物管理局的审查：1) 聚乙二醇化干扰素 + 利巴韦林 + 特拉匹韦和 2) 聚乙二醇化干扰素 + 利巴韦林 + 博普瑞韦。两者都与 SVR 率增加相关，并且与聚乙二醇化干扰素和利巴韦林标准治疗相比，两者都会增加毒性风险。治疗方案的持续时间也有所不同。考虑到这些权衡，开始哪种治疗的决定（假设患者是所有三种治疗的候选者并且可以获得这三种治疗）理想情况下应取决于知情患者的选择。然而，尚无行之有效的方法来实施个性化决策规划。 该项目的近期目标是修改先前开发的 HSRD 资助的决策支持工具，以改善患者教育并使患者能够构建自己的 HCV 治疗偏好。将创建该工具的两个版本，以便能够向初治患者和无反应者/复发者提供个性化信息。我们还将有目的地招募不同的患者样本，以评估种族对患者决策的影响。这些数据将帮助退伍军人管理局针对新的丙肝治疗需求制定计划。我们建议通过以下目标来实现我们的目标： 具体目标 1：为 HCV 治疗候选者修改现有的决策支持工具。该工具将被修改为：i) 包括交互式、个性化、教育内容和患者知识评估，ii) 包括一项引出患者对 HCV 概念化的任务，iii) 扩大治疗选择，使受试者能够构建对特拉匹韦和博普瑞韦的新三联疗法组合的偏好，iv) 向患者提供反馈，说明他们的权衡如何转化为特定的治疗偏好，v) 使患者能够识别和 打印出他们想与医生讨论的具体问题。此外，为了最大限度地提高未来的使用率，将开发该工具，以便可以在诊所或团体环境中对个体患者进行管理（例如与丙型肝炎资源中心的教育课程结合使用）。将创建该工具的两个版本，以便能够向初治患者和无反应者/复发者提供个性化信息。具体目标 2：通过确定决策支持工具对 VA 提供者和患者的可接受性、在两种环境（个体患者和群体）中使用该工具的可行性，以及通过在前后测试试点研究中获得可靠性、有效性和功效的初步证据，为干预试验做好准备。具体目标 3：描述患者对新的抗病毒联合治疗方案的偏好，并比较非西班牙裔白人、非西班牙裔黑人和西班牙裔退伍军人之间的偏好。这些数据将有助于退伍军人管理局针对未来新的丙肝治疗需求进行规划。 该工具将具有三个目标：1) 向患者介绍可用的治疗方案，并随后验证他们是否具备做出明智选择所需的最低限度的知识，2) 让患者能够构建自己的治疗偏好，3) 生成个性化表格，描述每位患者对 HCV 相关的疾病认知、他们的治疗偏好、他们偏好的原因以及他们希望与提供者讨论的具体问题。这些目标遵循 VA 促进以患者为中心的护理、知情同意和患者自主权的原则，并符合要求对 HCV 引起的轻度至中度肝病患者进行个体化决策的指南。 这项研究产生的数据将支持一项干预试验，以检查添加此决策支持工具对患有丙肝病毒的退伍军人的护理质量的影响。具体来说，我们假设，添加此工具将提高 1) 退伍军人做出知情且价值一致的选择的可能性，2) VA 提供者和考虑 HCV 治疗的退伍军人之间的沟通质量，3) 退伍军人根据其预测选择开始治疗的可能性，4) 坚持治疗，5) 对护理的满意度，以及 6) 获得 SVR 的退伍军人的比例。