Hartford Institute for Geriatric Nursing, NYU Rory Meyers College of Nursing, New York, New York, USA.
College of Nursing, University of Utah, Salt Lake City, Utah, USA.
Gerontologist. 2022 Feb 9;62(2):304-314. doi: 10.1093/geront/gnaa220.
Many investigators of Alzheimer's disease and related dementias (AD/ADRD) are unfamiliar with the embedded pragmatic clinical trials (ePCTs) and the indispensable pilot phase preceding ePCTs. This paper provides a much-needed example for such a pilot phase and discusses implementation barriers and additional infrastructure and implementation strategies developed in preparation for a nationwide AD/ADRD ePCT.
Two pilot trials were conducted in 2 hospices sequentially to refine and test Aliviado Dementia Care-Hospice Edition, a complex quality improvement intervention for advanced dementia symptom management. Readiness for the subsequent full-scale ePCT was assessed by three milestones: ≥80% training completion rate ("feasibility"), ≥80% posttraining survey respondents indicating intention for practice changes ("applicability"), and at least 1 Aliviado care plan/assessment instrument administered in ≥75% of dementia patients admitted to home hospice within 1-month posttraining ("fidelity").
Participants included 72 interdisciplinary team members and 11 patients with AD/ADRD across the pilots. Feasibility, applicability, and fidelity outcomes (92%, 93%, and 100%, respectively) all surpassed the preestablished milestones (80%, 80%, and 75%). Main implementation challenges were related to hospice staff turnover, integration of the Aliviado toolbox materials within the electronic health records, and hospices' limited research experience and infrastructure.
This pilot phase demonstrated feasibility, applicability, and fidelity required to proceed to the full-scale ePCT. Our study findings and discussions of additional infrastructure and implementation strategies developed following the pilot phase can inform researchers and clinicians interested in conducting AD/ADRD-related pilot studies for ePTCs or quality improvement initiatives.
NCT03681119.
许多阿尔茨海默病和相关痴呆症（AD/ADRD）的研究者对嵌入式实用临床试验（ePCT）以及 ePCT 之前必不可少的试点阶段并不熟悉。本文提供了一个急需的试点阶段示例，并讨论了为全国性 AD/ADRD ePCT 做准备而开发的实施障碍以及额外的基础设施和实施策略。
在 2 家临终关怀机构中连续进行了 2 项试点试验，以完善和测试用于晚期痴呆症状管理的复杂质量改进干预措施——Aliviado 痴呆护理-临终关怀版。通过三个里程碑来评估后续全面 ePCT 的准备情况：培训完成率≥80%（“可行性”）、培训后至少 80%的调查对象表示有实践改变的意向（“适用性”）、以及在培训后 1 个月内，至少有 75%的新入住家庭临终关怀的痴呆患者接受了 1 份 Aliviado 护理计划/评估工具（“保真度”）。
2 项试点研究共纳入 72 名跨学科团队成员和 11 名 AD/ADRD 患者。可行性、适用性和保真度的结果（分别为 92%、93%和 100%）均超过了既定的里程碑（80%、80%和 75%）。主要实施挑战与临终关怀工作人员的更替、Aliviado 工具包材料与电子病历的整合以及临终关怀机构有限的研究经验和基础设施有关。
该试点阶段证明了进行全面 ePCT 的可行性、适用性和保真度。我们的研究结果以及对试点阶段后开发的额外基础设施和实施策略的讨论，可以为有兴趣进行 AD/ADRD 相关 ePCT 或质量改进计划的研究人员和临床医生提供信息。
NCT03681119。
