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

项目概要/摘要 阿尔茨海默氏病和相关痴呆症 (ADRD) 患者经常经历高强度、 临终时可能会面临繁重的护理，这可能与他们的价值观和目标不一致。患者患有 ADRD 及其家人经常面临关于最合适护理强度的复杂决定。目标-- 与临床医生的护理讨论与改善患者和家庭的结果有关，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的实现 护理中，它们目前很少发生或在疾病发生时为时已晚。电子健康记录 (EHR) 提供了关键 有机会识别将从这些讨论中受益的患者并促进这些讨论，但 之前很少有干预措施将 EHR 用于此目的。为了解决这一差距，我们提出了 NIH 第三阶段 沟通启动干预措施的混合功效-效果试验，称为 Jumpstart，以提高 与 ADRD 患者及其家庭护理人员进行护理目标讨论的发生率和质量 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，我们将对改编后的 Jumpstart 干预措施进行 NIH III 期混合功效-效果试验 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 护理讨论并改善患者和家属报告的结果。主要结果是 EHR 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 及其家庭照顾者。目标 2 检查重要干预措施的作用机制 以患者和家庭为中心的结果，包括患者的姑息治疗需求以及干预措施对患者的影响 医疗保健利用，并监测干预措施在心理方面的意外后果 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来探索 进一步改进干预措施并确定干预措施实施的障碍和促进因素。 我们的团队完全有能力实现这些目标。我们拥有开展大型、 以患者和家庭为中心的结果、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。我们已经使用了信息学 与 EHR 集成，以识别 ADRD 患者并测量与方法类似的护理质量 此处提出，包括主要结果的衡量。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了解 Jumpstart 的功效 干预以改善沟通并促进目标一致的护理，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治疗结果。

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.