RCT of Patient, Caregiver and Physician Communication Coaching in Advanced Cancer

描述（由申请人提供）：在严重疾病的背景下，精心设计符合患者意愿的护理需要清晰，坦率和敏感的沟通，重点是对患者最重要的问题。我们的目标是测试一种潜在的强大干预措施-针对医生，患者和护理人员-以改善有关晚期癌症预后和治疗选择的讨论。这些讨论对于让患者参与他们的护理至关重要，无论他们是否愿意承担做出重大医疗保健决定的责任。进行过这些讨论的患者不太可能被误导，不太可能得到不必要的积极护理，更有可能体验到改善的幸福感。然而，这些重要的讨论往往不会发生。正如生态学理论所预测的那样，以个人为中心的干预措施--针对临床医生或患者，或利用第三方--在改善沟通方面的益处有限。我们的方法以生态学理论为基础，旨在通过调整患者，护理人员和医生的沟通来优化沟通-以及患者的福祉。在本次重新提交中，我们对PA-09-122：患有或有风险患危及生命疾病的患者的临床决策研究做出了回应，并有新的具体目标：确定患者/护理人员和医生的联合干预是否a）改善晚期癌症预后和治疗选择的沟通（主要结局），B）改善患者福祉和c）影响卫生服务利用。设计是一项双中心随机对照试验，采用双组分干预，旨在改善晚期癌症预后和治疗选择的沟通，并促进患者参与有关其护理的讨论。肿瘤学家（N=30）将被随机分配到日常护理控制或干预：两个在办公室会议提供个人定制的反馈，他们的沟通技巧。晚期癌症患者（n = 300）及其护理人员将被分配到常规护理控制或干预：访视前指导和问题提示列表，以解决与医生相同的沟通目标。我们已经试行了干预的两个组成部分。从患者-护理人员-肿瘤学家的音频记录访问中获得的主要结果指标将评估a）互动沟通，包括回应患者的担忧;告知患者治疗选择;平衡的框架;以及让患者参与决策。我们还将使用患者和护理人员调查评估B）访视后1周的沟通和研究入组时以及每3个月一次的患者健康（心理困扰、生活质量、平静感和死亡质量）;以及c）使用图表审核评估生命最后一周积极干预措施的使用以及研究入组后的姑息治疗和临终关怀咨询。意义：拟议的研究解决了在限制生命的疾病背景下有效沟通的关键重要障碍。这是第一个测试针对医生，患者和护理人员的新型沟通干预措施，并且可以扩展传播。

DESCRIPTION (provided by applicant): Crafting care that is concordant with the patient's wishes in the context of serious illness requires clear, frank and sensitive communication focused on the issues of greatest importance to the patient. We aim to test a potentially powerful intervention - targeting physicians, patients and caregivers - to improve discussions regarding prognosis and treatment choices in advanced cancer. These discussions are critical to involving patients in their care, whether or not they wish to assume responsibility for making major health care decisions. Patients who have had these discussions are less likely to be misinformed about the illness, less likely to get unwarranted aggressive care and more likely to experience improved well-being. Yet, these crucial discussions frequently do not occur. As predicted by ecological theory, individually-focused interventions - targeting clinicians or patients, or using third parties - are of limited benefit in improving communication. Our approach, informed by ecological theory, is designed to optimize communication - and patient well-being - by aligning patient, caregiver and physician communication towards common goals. In this resubmission, we respond to PA-09-122: Research on Clinical Decision Making in People with or at Risk for Life-Threatening Illness and have new Specific Aims: To determine whether a combined intervention for patients/caregivers and physicians a) improves communication regarding prognosis and treatment choices in advanced cancer (primary outcome), b) improves patient well-being and c) affects health services utilization. Design is a two-site cluster RCT of a 2- component intervention designed to improve communication about prognosis and treatment choices in advanced cancer and promote patient participation in discussions regarding their care. Oncologists (N=30) will be randomized to usual-care control or the intervention: two in-office sessions providing individual tailored feedback on their communication skills. Patients (n = 300) with advanced cancer and their caregivers will be assigned to usual-care control or the intervention: pre-visit coaching and question-prompt lists to address the same communication goals as physicians. We have piloted both components of the intervention. Main outcome measures derived from audio-recorded patient-caregiver-oncologist visits will assess a) interactive communication, including responding to patients' concerns; informing patients about treatment choices; balanced framing of prognoses; and engaging patients to participate in decisions. We will also assess b) communication 1 week following the visit and patient well-being (psychological distress, quality of life, sense of peace, and quality of death) at study entry and every 3 months using patient and caregiver surveys; and c) utilization of aggressive interventions in the last week of life and palliative care and hospice consultations following study enrollment using chart audit. Significance: The proposed study addresses critically important barriers to effective communication in the context of life-limiting illness. It is the first to test a novel communication intervention targeting physicians, patients and caregivers, and it is scalable for dissemination.