Patient self-management and gene guided therapy for CHC

描述（由申请人提供）：慢性丙型肝炎（CHC）的治疗将在今年发生巨大变化，当时一种新的血液检测方法用于检测白细胞介素28 B（IL 28 B）基因附近的遗传多态性，两种新批准的蛋白酶抑制剂用于增强患者的反应。该多态性是基因型1感染患者治疗反应的强预测因子，两种蛋白酶抑制剂可能治愈CHC。随着基因检测结果指导新疗法，预计会使症状恶化，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，以分享新的信息，并检查分享的方式是否会随着时间的推移影响患者的症状和SM。适应性领导框架提供了一个有用的方法来描述病人与供应商之间的关系，区分技术工作，适应性挑战和适应性领导。 这项为期2年的探索性混合方法纵向病例研究（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检测结果和治疗的背景下促进或阻碍患者的SM。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24周的CHC治疗期间，这项工作与SM的关系; 2）描述提供者在临床就诊期间使用T-WORK和A-LEAD方法，3）描述与患者和提供者报告T-WORK相关的疾病感知、症状、病毒载量和SM的轨迹，A-WORK和A-LEAD从首次临床就诊到随访治疗反应就诊（约24周）。我们将在索引临床接触后采访患者和提供者，以探索他们对T-WORK，A-WORK和A-LEAD的解释，然后在24周的治疗中通过电话采访每位患者6次，以探索他们如何以及为什么参与SM以及提供者的T-WORK和A-LEAD如何促进或构成SM的障碍。治疗结束时将与患者和提供者进行面谈。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：患者激活测量值，M.D.安德森症状量表、病毒载量和疾病感知量表的控制/治愈子量表。有8个数据收集点。患者病例是分析单位。将计算每种仪器的评分，并用于绘制每名受试者的症状轨迹。来自临床接触和深入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，明显的意义的方法。定性和定量数据将使用联合矩阵分析加以整合。 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依从性，慢性丙型肝炎是美国最常见的血液传播感染，因此，必须找出新的方法来处理临床遇到的问题。 适应性领导框架提供了一种有用的方式来描述病人与供应商之间的关系，区分技术和适应性工作，适应性领导，以加强自我管理，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.