Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, 624 N Broadway, Baltimore, MD 21205, USA.
Johns Hopkins School of Nursing, 525 N. Wolfe St, Baltimore, MD 21205, USA.
Contemp Clin Trials. 2022 Aug;119:106818. doi: 10.1016/j.cct.2022.106818. Epub 2022 Jun 8.
Advance care planning (ACP) and involving family are particularly important in dementia, and primary care is a key setting. The purpose of this trial is to examine the impact and implementation of SHARING Choices, an intervention to improve communication for older adults with and without dementia through proactively supporting ACP and family engagement in primary care.
We cluster-randomized 55 diverse primary care practices across two health systems to the intervention or usual care. SHARING Choices is a multicomponent intervention that aims to improve communication through patient and family engagement in ACP, agenda setting, and shared access to the patient portal for all patients over 65 years of age. The primary outcomes include documentation of an advance directive or medical orders for life-sustaining treatment in the electronic health record (EHR) at 12 months for all patients and receipt of potentially burdensome care within 6 months of death for the subgroup of patients with serious illness. We plan a priori sub-analysis for patients with dementia. Data sources include the health system EHRs and the Maryland health information exchange. We use a mixed-methods approach to evaluate uptake, fidelity and adaptation of the intervention and implementation facilitators and barriers.
This cluster-randomized pragmatic trial examines ACP with a focus on the key population of those with dementia, implementation in diverse settings and innovative approaches to trial design and outcome abstraction. Mixed-methods approaches enable understanding of intervention delivery and facilitators and barriers to implementation in rapidly changing health care systems.
gov Identifier: NCT04819191.
在痴呆症中，预先医疗照护计划（ACP）和让家属参与尤其重要，而初级保健是一个关键场所。本试验的目的是检验 SHARING Choices 的影响和实施，这是一项通过主动支持 ACP 和初级保健中的家属参与来改善有或没有痴呆症的老年人沟通的干预措施。
我们将两个医疗系统中的 55 个不同的初级保健实践进行聚类随机分配至干预组或常规护理组。SHARING Choices 是一种多组分干预措施，旨在通过患者和家属参与 ACP、设定议程以及为所有 65 岁以上患者共享患者门户来改善沟通。主要结果包括在所有患者的电子健康记录（EHR）中记录在 12 个月时的预先医疗指示或维持生命治疗的医疗指令，以及在患有严重疾病的患者亚组中在 6 个月内接受潜在负担过重的护理。我们计划对患有痴呆症的患者进行预先分析。数据来源包括医疗系统的 EHR 和马里兰州健康信息交换。我们采用混合方法来评估干预措施的接受程度、保真度和适应性以及实施的促进因素和障碍。
这项聚类随机实用试验检查了 ACP，重点关注痴呆症关键人群，在不同环境中实施以及对试验设计和结果抽象的创新方法。混合方法方法能够了解在快速变化的医疗保健系统中干预措施的实施情况和促进因素和障碍。
gov 标识符：NCT04819191。
