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: 8108801
• 负责人: Ronald M. Epstein
• 金额: $ 56.59万
• 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/8108801
• 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. PUBLIC HEALTH RELEVANCE: The proposed research tests whether a newly-developed coaching intervention for oncologists, patients with advanced cancer and their caregivers promotes communication about prognosis and treatment choices. The intervention is designed to improve communication, and result in care that respects the patient's wishes, meets patients' needs for information and emotional support, reduces psychological distress, and improves shared understanding, quality of life and sense of peace. This research has the potential to help thousands of people with advanced cancer who face a limited prognosis; they often have unanswered questions and unmet emotional needs, and are not sufficiently involved in choices regarding their care.

描述(由申请人提供)：在严重疾病的情况下，精心设计符合患者意愿的护理需要明确、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有力的干预--针对医生、患者和照顾者--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，无论他们是否希望承担做出重大卫生保健决定的责任。进行过这些讨论的患者不太可能被错误地告知疾病，不太可能得到不必要的积极治疗，更有可能体验到改善的幸福感。然而，这些关键的讨论往往不会发生。正如生态学理论所预测的那样，针对临床医生或患者或使用第三方的个别重点干预措施在改善沟通方面益处有限。我们的方法受到生态学理论的启发，旨在通过将患者、护理者和医生的沟通与共同目标保持一致，来优化沟通--以及患者的福祉。在此次重新提交中，我们响应PA-09-122：患有或有生命危险疾病的人的临床决策研究，并有了新的具体目标：确定患者/照顾者和医生的联合干预是否a)改善关于晚期癌症(主要结果)预后和治疗选择的沟通，b)改善患者福祉，c)影响医疗服务的利用。设计是一种双部位群集式随机对照试验，包括两组分干预，旨在改善关于晚期癌症预后和治疗选择的沟通，并促进患者参与有关他们的护理的讨论。肿瘤学家(N=30)将被随机分为常规护理对照组或干预组：两次办公室会议，提供关于他们沟通技能的个性化反馈。300名晚期癌症患者和他们的照顾者将被分配到常规护理对照组或干预组：来访前辅导和问题提示列表，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。由录音记录的患者-护理员-肿瘤医生访问得出的主要结果衡量标准将评估a)互动沟通，包括回应患者的关切；告知患者治疗选择；平衡制定预后；以及让患者参与决策。我们还将使用患者和照顾者调查来评估b)访问后1周的沟通以及研究开始时和每3个月患者的幸福感(心理困扰、生活质量、和平感和死亡质量)；以及c)使用图表审计在研究登记后的最后一周使用积极干预措施以及姑息治疗和临终关怀咨询。意义：这项拟议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、患者和护理人员的新型沟通干预，而且它是可扩展的传播。 公共卫生相关性：这项拟议的研究测试了新开发的针对肿瘤学家、晚期癌症患者及其照顾者的指导干预是否促进了关于预后和治疗选择的沟通。这种干预旨在改善沟通，产生尊重患者意愿的护理，满足患者对信息和情感支持的需求，减少心理痛苦，并提高共同理解、生活质量和和平感。这项研究有可能帮助数以千计的晚期癌症患者，他们面临的预后有限；他们经常有未得到回答的问题和未得到满足的情感需求，并且没有充分参与到关于他们的护理的选择中。