Improving Palliative Care for Older Seriously Hospitalized Patients and Their Families: A Randomized Trial of an Informed Assent Communication Intervention about CPR

改善老年严重住院患者及其家人的姑息治疗：关于心肺复苏知情同意沟通干预的随机试验

• 批准号: 9266706
• 负责人: Renee D Stapleton
• 金额: $ 50.24万
• 依托单位: UNIVERSITY OF VERMONT & ST AGRIC COLLEGE
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-05-01 至 2021-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9266706
• 关键词: Admission activity; Adult; Anxiety; Cardiopulmonary Resuscitation; Caring; Cessation of life; Chronic Disease; Chronically Ill; Collaborations; Communication; Communication Methods; Data; Do Not Resuscitate Order; Elderly; Enrollment; Family; Family member; Feeling; Goals; Home environment; Hospitalization; Hospitals; Impaired cognition; Intervention; Journals; Knowledge; Life; Measures; Medicine; Methodology; Multicenter Studies; New England; Outcome; Palliative Care; Patient Recruitments; Patients; Perception; Phase; Physicians; Pilot Projects; Positioning Attribute; Procedures; Provider; Publishing; Quality of Care; Randomized Controlled Trials; Regrets; Research; Research Personnel; Research Proposals; Stress; Survival Rate; Survivors; Symptoms; Time; Training; Work; anxiety symptoms; attentional control; cost; depressive symptoms; end-of-life communication; experience; functional disability; health care service utilization; hospital readmission; improved; innovation; novel; older patient; patient oriented; preference; public health relevance; randomized trial; reduce symptoms; satisfaction; stress symptom; treatment as usual

 DESCRIPTION (provided by applicant): High quality palliative care and communication in older patients improves quality of care, patient and family satisfaction, and costs of care. One important component of communication is discussing cardiopulmonary resuscitation (CPR), as this is required for every hospital admission and most older patients have not discussed CPR prior to hospitalization. Unfortunately, these conversations are often inadequate and leave patients and families feeling burdened, stressed, and concerned. Outcomes after in-hospital CPR in chronically ill older patients continue to be very poor, despite decades of efforts toward improvement. Our prior work has shown that an increasing proportion of hospitalized older adults receive CPR before death with continued poor survival rates and that the longer-term benefits of CPR are decreasing with fewer patients discharged home after CPR. Additionally, when compared to those without chronic illness, older patients with advanced chronic illness have significantly worse hospital discharge and long-term survival after CPR, and among survivors, experience more hospital readmissions until death and are less likely to be discharged home. We have recently successfully completed two pilot studies of a novel "informed assent" approach to discussing CPR, a specific communication framework whereby older patients who meet specific criteria and do not wish to remain alive at all costs are informed that they should not receive CPR. Our preliminary data demonstrate that this intervention is feasible and well-received by patients, family members, and physicians. Additionally, among patients who wanted CPR at enrollment in our pilot RCT, significantly more patients receiving the intervention changed their preferences to "no CPR" than did control patients. We therefore propose a phase II proof-of-concept RCT comparing our innovative informed assent intervention versus usual care with attention control for older hospitalized adults with severe life-limiting illness or functional or cognitive impairment, enrolling patients and family members. We hypothesize that informed assent will improved quality of and satisfaction with communication about CPR; reduce the burden of potentially harmful CPR discussions, including reduced patient and family symptoms of depression, anxiety and decisional regret; and reduce intensity of care and health care utilization. The research team proposing this project, led by an Early Stage Investigator, has extensive experience with RCTs and patient recruitment, as well as years of successful collaboration, including recent completion of two pilot studies of informed assent. They are well positioned to conduct this study that aims to change the paradigm of CPR discussions with older adults unlikely to benefit from CPR. If effective, this informed assent intervention has the potential to revolutionize discussions about CPR with chronically ill older patients.

 描述（由申请人提供）：老年患者的高质量姑息治疗和沟通提高了护理质量、患者和家属满意度以及护理成本。沟通的一个重要组成部分是讨论心肺复苏术（CPR），因为这是每次住院所必需的，大多数老年患者在住院前没有讨论过CPR。不幸的是，这些对话往往是不够的，让病人和家属感到负担，压力和关注。尽管经过几十年的努力，在慢性病老年患者中进行院内心肺复苏术后的结果仍然很差。我们之前的工作表明，越来越多的住院老年人在死亡前接受心肺复苏术，存活率持续低下，心肺复苏术的长期益处正在减少，心肺复苏术后出院的患者越来越少。此外，与没有慢性疾病的患者相比，患有晚期慢性疾病的老年患者在心肺复苏术后的出院和长期生存率显着更差，并且在幸存者中，经历更多的再次住院直至死亡，并且不太可能出院回家。我们最近成功地完成了两个试点研究的一个新的“知情同意”的方法来讨论心肺复苏术，一个特定的沟通框架，使老年患者谁符合特定的标准，不希望继续活着不惜一切代价的通知 他们不应该接受心肺复苏。我们的初步数据表明，这种干预是可行的，并受到患者，家庭成员和医生的欢迎。此外，在我们的试点RCT中，在登记时想要CPR的患者中，与对照患者相比，接受干预的患者明显更多地改变了他们的偏好“无CPR”。因此，我们提出了一项II期概念验证随机对照试验，比较我们的创新知情同意干预与常规护理与注意力控制，用于患有严重生命限制性疾病或功能或认知障碍的老年住院成人，招募患者和家庭成员。我们假设，知情同意将提高质量和满意度的沟通心肺复苏术;减少潜在有害的心肺复苏术讨论的负担，包括减少患者和家庭的抑郁症，焦虑和决策后悔的症状;并降低强度的护理和卫生保健利用。提出该项目的研究团队由早期研究者领导，在RCT和患者招募方面拥有丰富的经验，以及多年的成功合作，包括最近完成的两项知情同意试点研究。他们有能力进行这项研究，旨在改变与不太可能从心肺复苏术中受益的老年人进行心肺复苏术讨论的范式。如果有效，这种知情同意干预有可能彻底改变慢性病老年患者对心肺复苏术的讨论。