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

晚期癌症患者、护理人员和医生沟通辅导的随机对照试验

• 批准号: 8634734
• 负责人: Ronald M. Epstein
• 金额: $ 51.78万
• 依托单位: UNIVERSITY OF ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-06-01 至 2016-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8634734
• 关键词: Address; Advanced Malignant Neoplasm; Affect; Attention; Caregivers; Caring; Charge; Communication; Communication Research; Consultations; Critical Illness; Data; Diagnosis; Emotional; Enrollment; Equilibrium; Face; Feedback; Frustration; Goals; Healthcare; Individual; Interactive Communication; Intervention; Intervention Studies; Life; Oncologist; Outcome; Outcome Measure; Palliative Care; Participant; Patient Participation; Patients; Personal Satisfaction; Physicians; Play; Quality of life; Randomized; Reporting; Research; Risk; Role; Severity of illness; Site; Surveys; Testing; Visit; base; clinical decision-making; communication behavior; design; expectation; experience; group intervention; health care service utilization; hospice environment; improved; insight; instructor; meetings; novel; outcome forecast; outreach; patient oriented; peace; primary outcome; prognostic; psychologic; psychological distress; quality of death; skills; social; sound; theories; therapy design; treatment as usual

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.

描述（由申请人提供）：在严重疾病的背景下，制定符合患者意愿的护理需要明确、坦率和敏感的沟通，重点关注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-以改善关于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卫生保健决定的责任。有过这些讨论的患者不太可能被错误地告知疾病，不太可能得到毫无根据的积极治疗，更有可能体验到改善的幸福感。然而，这些关键的讨论往往没有发生。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，或使用第三方——在改善沟通方面的好处有限。我们的方法以生态学理论为依据，旨在通过调整患者、护理人员和医生的沟通来实现共同的目标，从而优化沟通和患者的健康。在本次再提交中，我们回应了PA-09-122：患者或有生命威胁疾病风险人群的临床决策研究，并有新的特定目的：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)影响医疗服务的利用。Design是一项双组分干预的双点群随机对照试验，旨在改善晚期癌症患者关于预后和治疗选择的交流，并促进患者参与有关其护理的讨论。肿瘤学家（N=30）将被随机分配到常规护理组或干预组：两次办公室会议，针对他们的沟通技巧提供个性化的反馈。晚期癌症患者（n = 300）及其护理人员将被分配到常规护理组或干预组：就诊前指导和问题提示列表，以解决与医生相同的沟通目标。我们对干预的两个组成部分都进行了试点。从患者-护理人员-肿瘤学家访问的录音中获得的主要结果测量将评估a)互动沟通，包括对患者关切的回应；告知患者治疗选择；平衡的预测框架；让病人参与决策。我们还将通过对患者和护理人员的调查，在研究开始时和每3个月评估b)访问后1周的沟通和患者的幸福感（心理困扰、生活质量、安宁感和死亡质量）；c)在使用图表审计的研究入组后，生命最后一周积极干预和姑息治疗和临终关怀咨询的使用情况。意义：提出的研究解决了在限制生命的疾病背景下有效沟通的至关重要的障碍。这是第一次测试一种针对医生、病人和护理人员的新型沟通干预措施，并且可扩展用于传播。