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）： 项目摘要慢性肝炎（HCV）是美国退伍军人的主要医疗保健负担。在接受过二乙二醇化Interferon和Ibavirin治疗的基因型1的患者中，持续病毒反应（SVR）的速率仅为20％。然而，预计2010年食品药品监督管理局将接受两种新的基于蛋白酶的组合治疗方案：1）Pegylated Interferon + Ribavirin + Ribavirin + telaprevir和2）Pegyperated Interterferon + Ribavirin + Ribavirin + Boceprevir。两者都与SVR率提高有关，并且两者都赋予了与卵甲膜相互作用和利巴韦林相对于标准治疗的毒性风险增加。治疗方案的持续时间也有所不同。鉴于这些权衡，要启动哪种治疗的决定（假设患者是候选者的候选者，并且可以使用这三者）应理想地取决于知情的患者的选择。但是，没有实施个性化决策计划的可靠方法。 该项目的直接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，并使患者能够建立其HCV的治疗偏好。将创建两个版本的工具，以便将个性化信息呈现给治疗NAOVE患者和无反应者/复发剂。我们还将有目的地招募各种患者样本，以评估种族对患者决策的影响。这些数据将帮助VA计划满足新的HCV治疗需求。我们建议通过以下目的实现目标：特定目的1：为候选人治疗HCV的退伍军人修改现有的决策支持工具。 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打印出他们想与医生讨论的具体问题。此外，为了最大程度地提高未来的摄取，将开发该工具，以便可以在诊所或小组环境中对单个患者进行管理（例如与丙型肝炎资源中心的教育类别）。将创建两个版本的工具，以便将个性化信息呈现给治疗NAOVE患者和无反应者/复发剂。具体目的2：通过确定决策支持工具对VA提供者和患者的可接受性，在两种情况下使用该工具的可行性，并通过在PES POST测试试验前研究中获得可靠性，有效性和功效的初步证据，以准备进行干预试验。特定目的3：描述患者对新抗病毒组合治疗方案的偏好，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VA计划，以满足新的HCV治疗的未来需求。 该工具将有三个目标：1）教育患者可用的治疗方案，然后确认他们具有最低的知识以做出知情选择，2）使患者能够构建他们的治疗偏好，3）生成一个个性化的形式，描述了每个患者的疾病知觉，与HCV相关的治疗偏好，他们的偏好的理由，以及他们的偏好和特定的关注者都可以与他们的偏好进行讨论。这些目标遵守VA促进患者护理，知情同意和患者自主权的原则，并符合针对HCV引起的轻度至中度肝病患者的个性化决策的准则。 这项研究产生的数据将支持一项干预试验，以研究添加此决策支持工具对使用HCV的退伍军人护理质量的影响。 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.