Patient self-management and gene guided therapy for CHC

描述(申请人提供)：慢性丙型肝炎(CHC)的治疗将在今年经历戏剧性的变化，因为一种新的血液检测白介素28B(IL28B)基因附近的基因多态和两种新批准的蛋白酶抑制剂被用于增强患者的反应。该基因多态是1型感染患者治疗反应的有力预测因子，这两种蛋白水解酶抑制剂可能治愈CHC。随着基因测试结果指导预计会恶化症状的新疗法，提供者与患者的互动甚至有更大的潜力影响症状轨迹和自我管理(SM)。因此，这项研究将探索提供者(医生、医生助理和护士)如何与患者互动以共享新信息，并检查共享信息的方式是否会随着时间的推移影响专利的症状和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-提供者关系的有用方法。这项为期两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什么从事技术工作(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阻碍患者的SM。具体目的是：1)检查T工作、A工作和A导联如何影响患者对其治愈可能性的看法，以及在治疗CHC的24周期间这项工作与SM之间的关系；2)描述提供者在临床会诊期间使用T工作和A导联方法的情况；3)描述从T工作、A工作和A导联的患者和提供者报告的T工作、A工作和A导联从索引临床遭遇到后续治疗反应(大约24周)的疾病感知、症状、病毒载量和SM的轨迹。我们将在索引临床会面后采访患者和提供者，以了解他们对T工作、A工作和A导联的解释，然后在24周的治疗中通过电话采访每位患者六次，以了解他们如何以及为什么参与SM，以及提供者的T工作和A导联如何促进或阻碍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，收集的以下衡量标准允许我们描述支持SM的A-Work：患者激活测量、M.D.安德森症状清单、病毒载量和疾病感知量表的控制/治愈分量表。共有8个数据采集点。病人病例是分析的单位。将计算每个仪器的分数，并用来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清单内容分析进行编码，这是一种用于探索来自多个来源的数据中可见的、明显的含义的方法。定性和定量数据将使用联合矩阵分析进行整合。 公共卫生相关性：为了促进慢性丙型肝炎患者的自我管理和坚持治疗，这是美国最常见的血液传播感染，必须找到管理临床接触的新方法。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，它区分了技术性工作和适应性工作，并通过适应性领导来加强自我管理，从而改善这些患者的治疗轨迹。

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.