Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, USA.
Department of Family Medicine, University of Colorado School of Medicine, Aurora, CO, USA.
Trials. 2020 Jun 18;21(1):542. doi: 10.1186/s13063-020-04482-0.
Most individuals with dementia or mild cognitive impairment (MCI) have multiple chronic conditions (MCC). The combination leads to multiple medications and complex medication regimens and is associated with increased risk for significant treatment burden, adverse drug events, cognitive changes, hospitalization, and mortality. Optimizing medications through deprescribing (the process of reducing or stopping the use of inappropriate medications or medications unlikely to be beneficial) may improve outcomes for MCC patients with dementia or MCI.
With input from patients, family members, and clinicians, we developed and piloted a patient-centered, pragmatic intervention (OPTIMIZE) to educate and activate patients, family members, and primary care clinicians about deprescribing as part of optimal medication management for older adults with dementia or MCI and MCC. The clinic-based intervention targets patients on 5 or more medications, their family members, and their primary care clinicians using a pragmatic, cluster-randomized design at Kaiser Permanente Colorado. The intervention has two components: a patient/ family component focused on education and activation about the potential value of deprescribing, and a clinician component focused on increasing clinician awareness about options and processes for deprescribing. Primary outcomes are total number of chronic medications and total number of potentially inappropriate medications (PIMs). We estimate that approximately 2400 patients across 9 clinics will receive the intervention. A comparable number of patients from 9 other clinics will serve as wait-list controls. We have > 80% power to detect an average decrease of - 0.70 (< 1 medication). Secondary outcomes include the number of PIM starts, dose reductions for selected PIMs (benzodiazepines, opiates, and antipsychotics), rates of adverse drug events (falls, hemorrhagic events, and hypoglycemic events), ability to perform activities of daily living, and skilled nursing facility, hospital, and emergency department admissions.
The OPTIMIZE trial will examine whether a primary care-based, patient- and family-centered intervention educating patients, family members, and clinicians about deprescribing reduces numbers of chronic medications and PIMs for older adults with dementia or MCI and MCC.
NCT03984396. Registered on 13 June 2019.
大多数痴呆症或轻度认知障碍（MCI）患者都患有多种慢性疾病（MCC）。这种组合导致了多种药物和复杂的用药方案，增加了发生重大治疗负担、药物不良事件、认知变化、住院和死亡的风险。通过减少用药（减少或停止使用不合适或可能无益的药物）来优化药物治疗，可能会改善痴呆症或 MCI 合并 MCC 患者的预后。
在患者、家属和临床医生的参与下，我们开发并试点了一项以患者为中心的实用干预措施（OPTIMIZE），以教育和激励患者、家属和初级保健临床医生了解减少用药，作为痴呆症或 MCI 合并 MCC 老年患者最佳药物管理的一部分。该基于诊所的干预措施针对的是服用 5 种或更多药物的患者、他们的家属和初级保健临床医生，采用实用的、集群随机设计，在科罗拉多州的 Kaiser Permanente 进行。该干预措施有两个组成部分：一个针对患者/家属的部分，重点是关于减少用药潜在价值的教育和激励；一个针对临床医生的部分，重点是提高他们对减少用药的选择和流程的认识。主要结局是慢性药物的总数和潜在不适当药物（PIMs）的总数。我们预计，大约 2400 名患者将接受 9 个诊所的干预措施。来自 9 个其他诊所的可比数量的患者将作为候补对照。我们有超过 80%的功效来检测平均减少 0.70（<1 种药物）。次要结局包括 PIM 的起始数量、选定 PIM（苯二氮䓬类、阿片类药物和抗精神病药）的剂量减少、药物不良事件（跌倒、出血事件和低血糖事件）的发生率、日常生活活动能力以及熟练护理设施、医院和急诊部入院的情况。
OPTIMIZE 试验将研究基于初级保健的、以患者和家庭为中心的干预措施，教育患者、家属和临床医生减少用药，是否可以减少痴呆症或 MCI 合并 MCC 老年患者的慢性药物和 PIM 数量。
NCT03984396. 于 2019 年 6 月 13 日注册。
