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临床试验/NCT05956665
NCT05956665已完成不适用

Adapting the Shed-MEDS Deprescribing Intervention to Dementia Care in Assisted Living

Vanderbilt University4 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2024年1月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
4
主要终点
Total Number of Medications That Have Been Deprescribed Since Enrollment

研究概览

简要总结

This single-arm pilot study will evaluate the effects of an intervention to reduce exposure to unnecessary or potentially harmful medications among residents with dementia living in an assisted living facility. The goal of the intervention is to safely deprescribe medications (defined by dose reductions and stopped medications), based on a combination of clinical criteria and resident/surrogate preferences. The investigators will evaluate the effects of the intervention on the total number of medications deprescribed from enrollment at 30, 60, and 90 days along with resident/surrogate reports of quality of life at enrollment and 90 days.

详细描述

This single-arm pilot trial will evaluate an evidence-based, patient-centered deprescribing intervention with assisted living facility (ALF) residents age 65+ who have a diagnosis of dementia. This deprescribing intervention was demonstrated to be safe and effective in reducing medication burden during the Shed-MEDS randomized clinical trial that enrolled hospitalized older adults discharging to post-acute care facilities. The intervention includes a comprehensive review of a participant's medications by the study's clinician and deprescribing recommendations using evidence-based guidelines. Deprescribing recommendations will be shared with residents/surrogate decision makers (i.e., respective family member/s) to determine their willingness to stop or reduce the dose of the targeted medications. If the resident/surrogate-decision maker agrees, deprescribing recommendations will then be communicated with the routine ALF medical providers for consideration and final deprescribing decisions.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Resident of assisted living facility
  • Speaks English (due to interview-based assessments)
  • Diagnosis of dementia
  • Taking a total of 5 medications or at least one potentially inappropriate medication (defined by the Beers criteria, STOPP criteria, and the Rationalization of home medication by an Adjusted STOPP in older Patients [RASP])
  • Able self-consent or has a proxy (surrogate)

排除标准

  • 未提供

结局指标

主要结局

Total Number of Medications That Have Been Deprescribed Since Enrollment

时间窗: 90 days

The number of medications (including all prescribed and over-the-counter medications and both scheduled and as-needed medications) that have been deprescribed since enrollment. Deprescribed is defined as either stopping or reducing the dose/frequency of a medication.

Resident Quality of Life

时间窗: 90 days

The Dementia Quality of Life Instrument-Proxy Version (DEMQOL-Proxy) is used to evaluate health-related quality of life in participants with severe dementia as rated by their caregivers. The DEMQOL-Proxy has 31 items which are reported on a four-point Likert scale (a lot/ quite a bit/ a little/ not at all) with a total score range from 31 to 124. Higher scores indicate a better health-related quality of life (i.e., higher scores are better).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer Kim

Professor

Vanderbilt University

研究点 (4)

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