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: 8699232
• 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/8699232
• 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; individualized medicine; 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）： 慢性丙型肝炎（HCV）是美国退伍军人的主要医疗负担。在基因型1的患者中，接受聚乙二醇干扰素和利巴韦林治疗的患者中，持续病毒学应答（SVR）率仅为20%。然而，两种新的基于蛋白酶底物的组合治疗方案预计将在2010年接受食品和药物管理局的审查：1）聚乙二醇干扰素+利巴韦林+特拉匹韦和2）聚乙二醇干扰素+利巴韦林+ boceprevir。两者都与SVR率增加有关，并且与聚乙二醇化干扰素和利巴韦林的标准治疗相比，两者都增加了毒性风险。治疗方案的持续时间也各不相同。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人，并且可以获得所有三种治疗）应该理想地取决于知情患者的选择。然而，目前还没有行之有效的方法来实施个性化的决策规划。 该项目的直接目标是修改以前开发的HSRD资助的决策支持工具，以改善患者教育，使患者能够构建他们的治疗偏好的HCV。将创建该工具的两个版本，以便向治疗初治患者和无应答者/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。这些数据将有助于VA计划新的HCV治疗的需求。我们建议通过以下目标来实现我们的目标：具体目标1：修改现有的决策支持工具，用于治疗丙型肝炎病毒的退伍军人。将对该工具进行修改，以i）包括交互式、个性化、教育组件和患者知识评估，ii）包括引出患者对HCV概念化的任务，iii）扩展治疗选项，使受试者能够构建对特拉匹韦和博赛匹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具体的治疗偏好，以及v）使患者能够识别并打印出他们想要与他们的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（例如与丙型肝炎资源中心的教育课程结合）对个别患者进行管理。将创建该工具的两个版本，以便向治疗初治患者和无应答者/复发者提供个性化信息。具体目标二：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（个体患者和组）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，有效性和有效性的初步证据，为干预试验做准备。具体目标3：描述患者对新型抗病毒联合治疗选择的偏好，并比较非西班牙裔白色、非西班牙裔黑人和西班牙裔退伍军人的偏好。这些数据将有助于VA计划未来对新HCV治疗的需求。 该工具将有三个目标：1）教育患者关于可用的治疗选择，并随后验证他们具有做出知情选择所需的最低限度的知识，2）使患者能够构建他们的治疗偏好，以及3）生成描述每个患者与HCV相关的疾病感知、他们的治疗偏好、他们的偏好背后的原因的个性化表格，以及他们想与供应商讨论的具体问题。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所致轻度至中度肝病患者进行个体化决策的指南。 本研究产生的数据将支持一项干预试验，以检查增加这种决策支持工具对HCV退伍军人护理质量的影响。具体来说，我们假设，添加此工具将提高1）退伍军人做出知情和价值一致选择的可能性，2）VA提供者和考虑治疗HCV的退伍军人之间的沟通质量，3）退伍军人开始治疗的可能性与他们的预测选择，4）坚持治疗，5）对护理的满意度，以及6）退伍军人达到SVR的比例。