Hybrid efficacy-effectiveness trial to promote goals-of-care discussions for patients with Alzheimer's disease and related dementias and their family caregivers

项目总结/摘要 阿尔茨海默病和相关痴呆症（ADRD）患者通常会经历高强度， 在接近生命结束时可能会有负担的护理，这可能与他们的价值观和目标不一致。患者 ADRD及其家人经常面临关于最适当的护理强度的复杂决定。目标 与临床医生讨论护理与改善患者和家庭结局相关， 在生命的最后时刻给予高度的关怀。尽管护理目标讨论可以促进目标一致性的交付， 护理，他们目前很少发生或太晚的疾病。电子健康记录（EHR）提供了一个关键 有机会确定哪些患者将从这些讨论中受益，并促进这些讨论， 少数先前的干预措施已将EHR用于此目的。为了弥补这一差距，我们建议在NIH第三阶段 一项名为Jumpstart的沟通启动干预的混合功效-效果试验， 与ADRD患者及其家庭照顾者讨论护理目标的发生率和质量 门诊设置。我们将使用EHR数据来识别患者并促进干预措施的实施。在 目标1，我们将对适应性Jumpstart干预进行NIH III期混合疗效-有效性试验 与常规护理相比，评估促进发生和改善目标质量的有效性， 护理讨论和改善患者和家庭报告的结果。主要成果是EHR 在入组后3个月内记录护理目标讨论。我们将招募1200名患者， ADRD及其家庭护理人员。目标2研究干预措施对重要的 以患者和家庭为中心的结局，包括患者的姑息治疗需求和干预对 医疗保健利用，并监测心理干预的意外后果 痛苦和一年全因死亡率。在目标3中，我们将进行混合方法评估，以探索 进一步改进干预措施，并确定实施干预措施的障碍和促进因素。 我们的团队有能力实现这些目标。我们有处理大型， 以患者和家庭为中心的结局、生物统计学、定性和混合方法的随机试验 分析，ADRD研究和政策，以及实施科学方法。我们利用信息学 与EHR集成，以识别ADRD患者并测量护理质量，方法类似 这里提出的，包括测量的主要成果。这项研究将为 ADRD患者、其家庭护理人员、临床医生和医疗保健系统对Jumpstart的疗效 干预，以改善沟通和促进目标一致的护理，并将提供见解， 实施类似的基于EHR的干预措施，旨在改善沟通和患者结局。

PROJECT SUMMARY/ABSTRACT Patients with Alzheimer’s disease and related dementias (ADRD) often experience high-intensity, potentially burdensome care near the end-of-life that may not align with their values and goals. Patients with ADRD and their families often face complex decisions about the most appropriate intensity of care. Goals-of- care discussions with clinicians are associated with improved patient and family outcomes and reduced intensity of care at the end of life. Although goals-of-care discussions can facilitate delivery of goal-concordant care, they currently occur infrequently or too late in the illness. Electronic health records (EHR) provide a key opportunity to identify patients who would benefit from these discussions and to promote these discussions, yet few prior interventions have used the EHR for this purpose. To address this gap, we propose an NIH Stage III hybrid efficacy-effectiveness trial of a communication-priming intervention, called Jumpstart, to increase the occurrence and quality of goals-of-care discussions with patients with ADRD and their family caregivers in the outpatient setting. We will use EHR data to identify patients and facilitate implementation of the intervention. In Aim 1, we will conduct a NIH Stage III hybrid efficacy-effectiveness trial of the adapted Jumpstart intervention compared to usual care to assess effectiveness for promoting occurrence and improving quality of goals-of care discussions and improving patient- and family-reported outcomes. The primary outcome is EHR documentation of a goals-of-care discussion by 3 months after enrollment. We will enroll 1200 patients with ADRD and their family caregivers. Aim 2 examines the mechanisms of action of the intervention on important patient- and family-centered outcomes including patients’ palliative care needs and the intervention’s effect on healthcare utilization, and monitors for unintended consequences of the intervention in terms of psychological distress and one-year all-cause mortality. In Aim 3, we will conduct a mixed-methods evaluation to explore further intervention improvements and identify barriers and facilitators to intervention implementation. Our team is well-positioned to accomplish these aims. We have experience conducting large, randomized trials with patient- and family-centered outcomes, biostatistics, qualitative and mixed methods analyses, ADRD research and policy, and implementation science methods. We have used informatics integrated with the EHR to identify patients with ADRD and measure quality of care similar to the methods proposed here, including measurement of the primary outcome. This study will provide important data for patients with ADRD, their family caregivers, clinicians, and healthcare systems on the efficacy of the Jumpstart intervention to improve communication and facilitate goal-concordant care and will provide insights for implementation of similar EHR-based interventions designed to improve communication and patient outcomes.