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

项目摘要/摘要 阿尔茨海默病和相关痴呆症(ADRD)患者经常经历高强度、 临终关怀可能会带来负担，可能与他们的价值观和目标不符。患有疾病的患者 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-- 与临床医生进行护理讨论与改善患者和家庭结果相关，并减少 临终关怀的强度。尽管护理目标讨论可以促进目标一致性的交付 护理方面，它们目前在疾病中罕见或发生得太晚。电子健康记录(EHR)提供了一把钥匙 确定哪些患者将从这些讨论中受益并促进这些讨论的机会，但 此前很少有干预措施将电子健康记录用于这一目的。为了解决这一差距，我们提出了NIH第三阶段 一种名为JumpStart的沟通启动干预的混合功效-有效性试验，以增加 与ADRD患者及其家庭照顾者的护理目标讨论的发生率和质量 门诊部。我们将使用电子病历数据来识别患者，并促进干预措施的实施。在……里面 目的1，我们将进行NIH第三阶段适应性JumpStart干预的混合疗效-有效性试验 与常规护理相比，评估促进目标发生和提高目标质量的有效性 护理讨论和改善患者和家庭报告的结果。主要结果是EHR 在注册后3个月内记录护理目标讨论。我们将招募1200名患者参加 ADRD和他们的家庭照顾者。目的2考察干预对重要疾病的作用机制。 以患者和家庭为中心的结果，包括患者的姑息治疗需求和干预对 医疗保健利用情况，并监测干预在心理方面的意外后果 痛苦和一年的全因死亡。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，并找出实施干预措施的障碍和促进者。 我们的团队有能力实现这些目标。我们有经验进行大型， 以患者和家庭为中心的随机试验、生物统计学、定性和混合方法 分析、反兴奋剂研究和政策，以及实施科学方法。我们使用了信息学 与电子病历相结合，以识别ADRD患者并衡量类似方法的护理质量 在此提出，包括对主要结果的衡量。这项研究将为以下工作提供重要数据 ADRD患者、他们的家庭照顾者、临床医生和医疗系统对JumpStart疗效的影响 旨在改善沟通和促进目标一致性护理的干预措施，并将为 实施类似的基于电子病历的干预措施，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.