Patient self-management and gene guided therapy for CHC

CHC 患者的自我管理和基因引导治疗

• 批准号: 8265041
• 负责人: Donald E Bailey
• 金额: $ 23.55万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-04-13 至 2014-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8265041
• 关键词: Address; Adherence; Adverse effects; Anemia; Blood; Blood Tests; Blood Transfusion; Caring; Case Study; Chronic Disease; Chronic Hepatitis C; Clinical; Clinical Data; Code; Complex; Data; Data Collection; Doctor of Medicine; Dose; Equipment and supply inventories; Fatigue; Fostering; Genes; Genetic Polymorphism; Genetic screening method; Genomics; Genotype; Health; Infection; Interleukins; Intervention; Interview; Joints; Knowledge; Lead; Leadership; Learning; Legal patent; Life; Measures; Methods; Modeling; Motivation; Nature; Nurses; Pain; Participant; Patients; Perception; Pharmaceutical Preparations; Physician Assistants; Physicians; Problem Solving; Protease Inhibitor; Provider; Regimen; Reporting; Research; Resources; Schedule; Self Management; Shapes; Solutions; Source; Symptoms; Telephone; Test Result; Time; Treatment Protocols; Viral Load result; Work; authority; base; cognitive change; design; experience; follow-up; illness perceptions; improved; indexing; insight; instrument; response; technical report; treatment response

DESCRIPTION (provided by applicant): Treatment for chronic hepatitis C (CHC) will undergo a dramatic change this year when a new blood test for a genetic polymorphism near the interleukin 28B (IL28B) gene and two newly approved protease inhibitors are used to enhance patient response. The polymorphism is a strong predictor of treatment response for patients with genotype 1 infection and the two protease inhibitors may cure CHC. With genetic test results guiding the new therapy that is expected to worsen symptoms, provider interactions with patients have even greater potential to influence symptom trajectories and self-management (SM). Thus, this study will explore how providers (physicians, physician assistants, and nurses) interact with patients to share the new information and examine whether the way it is shared influences patents' symptoms and SM over time. The adaptive leadership framework provides a useful way to describe the patient-provider relationship by distinguishing between technical work, adaptive challenges and adaptive leadership. This 2 year exploratory mixed-methods longitudinal case study (n=18) will describe patients' and providers' explanations of how and why they engage in technical work (T-WORK), adaptive work (A-WORK), and adaptive leadership (A-LEAD) and how these strategies promote or pose barriers to patients' SM in the context of the new genetic test results and treatments. Specific aims are to: 1) Examine how T-WORK, A- WORK and A-LEAD influence patients' perceptions of their likelihood of cure and how this work relates to SM during 24 weeks of treatment for CHC; 2) Describe providers' use of T-WORK and A-LEAD approaches during clinical encounters and 3) Describe the trajectories of illness perceptions, symptoms, viral load, and SM in relation to patient and provider reports of T-WORK, A-WORK and A-LEAD from the index clinical encounter to the follow-up treatment response encounter (approximately 24 weeks). We will interview patients and providers after the index clinical encounter to explore their explanations of T-WORK, A-WORK, and A-LEAD and then interview each patient six times by telephone over 24 weeks of treatment to explore how and why they engage in SM and how the T-WORK and A-LEAD of providers promotes or poses barriers to SM. Patients and providers will be interviewed at the end of treatment. The following measures collected over time allow us to describe A-WORK that supports SM: Patient Activation Measure, M.D. Anderson Symptom Inventory, viral load and the Control/Cure subscale of the Illness Perception Scale. There are 8 data collection points. The patient case is the unit of analysis. Scores will be calculated for each instrument and used to plot trajectories o symptoms for each participant. Data from clinical encounters and in-depth interviews will be coded using manifest content analysis, an approach used to explore visible, obvious meaning in the data from multiple sources. The qualitative and quantitative data will be integrated using joint matrix analyses. PUBLIC HEALTH RELEVANCE: In order to promote self-management and adherence in patients with chronic hepatitis C, the most common blood-borne infection in the U.S., it is essential to identify new ways of managing the clinical encounter. The adaptive leadership framework provides a useful way to describe the patient-provider relationship by distinguishing between technical and adaptive work, and adaptive leadership to enhance self-management and thus improve the treatment trajectory for these patients.

描述（由申请人提供）：今年慢性丙型肝炎 (CHC) 的治疗将发生巨大变化，届时将使用针对白细胞介素 28B (IL28B) 基因附近的遗传多态性的新血液检测以及两种新批准的蛋白酶抑制剂来增强患者的反应。该多态性是基因 1 型感染患者治疗反应的有力预测因素，两种蛋白酶抑制剂可能治愈 CHC。随着基因检测结果指导预计会使症状恶化的新疗法，提供者与患者的互动更有可能影响症状轨迹和自我管理（SM）。因此，本研究将探讨提供者（医生、医生助理和护士）如何与患者互动以共享新信息，并检查共享方式是否会随着时间的推移影响患者的症状和 SM。适应性领导框架通过区分技术工作、适应性挑战和适应性领导，提供了一种描述患者与提供者关系的有用方法。 这项为期 2 年的探索性混合方法纵向案例研究 (n=18) 将描述患者和提供者对他们如何以及为何从事技术工作 (T-WORK)、适应性工作 (A-WORK) 和适应性领导 (A-LEAD) 的解释，以及这些策略如何在新的基因测试结果和治疗的背景下促进或对患者的 SM 造成障碍。具体目标是： 1) 检查 T-WORK、A-WORK 和 A-LEAD 如何影响患者对其治愈可能性的看法，以及在 CHC 治疗 24 周期间这项工作与 SM 有何关系； 2) 描述提供者在临床接触期间对 T-WORK 和 A-LEAD 方法的使用，以及 3) 描述从索引临床接触到后续治疗反应接触（大约 24 周）期间与患者和提供者的 T-WORK、A-WORK 和 A-LEAD 报告相关的疾病感知、症状、病毒载量和 SM 的轨迹。我们将在索引临床接触后采访患者和提供者，探讨他们对 T-WORK、A-WORK 和 A-LEAD 的解释，然后在 24 周的治疗期间通过电话采访每位患者六次，以探讨他们如何以及为何参与 SM，以及提供者的 T-WORK 和 A-LEAD 如何促进或阻碍 SM。患者和提供者将在治疗结束时接受采访。随着时间的推移收集的以下测量值使我们能够描述支持 SM 的 A-WORK：患者激活测量、M.D. Anderson 症状量表、病毒载量和疾病感知量表的控制/治愈子量表。共有8个数据采集点。患者病例是分析单位。将为每个仪器计算分数，并用于绘制每个参与者的症状轨迹。来自临床接触和深度访谈的数据将使用明显内容分析进行编码，这是一种用于探索多个来源数据中可见、明显含义的方法。将使用联合矩阵分析来整合定性和定量数据。 公共卫生相关性：为了促进慢性丙型肝炎（美国最常见的血源性感染）患者的自我管理和依从性，必须找到管理临床情况的新方法。 适应性领导框架提供了一种有用的方法来描述患者与提供者的关系，通过区分技术工作和适应性工作，以及适应性领导来增强自我管理，从而改善这些患者的治疗轨迹。