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临床试验/NCT03405298
NCT03405298已完成不适用

Reducing Inappropriate Benzodiazepine Use Among Older Adults

University of Michigan2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2018年2月8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
44
试验地点
2
主要终点
Change in avg. daily dose of benzodiazepine prescribed in lorazepam-equivalent mg

研究概览

简要总结

The goal of this project is to reduce chronic benzodiazepine use through two approaches: direct patient education or direct patient education paired with additional support and encouragement from a behavioral health care manager.

详细描述

This is a State of Michigan/Medicaid Match project proposal. These proposed projects are developed to address specific goals for Medicaid policies, procedures, and model programs for Medicaid Recipients in Michigan.

Benzodiazepine use in the United States is common and increases with age, used by 8.7% of patients aged 65-80 years. Benzodiazepines-which include well-known medications such as Xanax, Ativan, and Klonopin-are most commonly used for anxiety and insomnia, even though psychotherapy and alternative medications are now recommended preferentially over benzodiazepines. Use is a particular concern among older adults, given the links between benzodiazepine prescribing and a variety of adverse outcomes including falls, fractures and motor vehicle accidents.

Attempts to reduce benzodiazepine use have met with limited success in the real world, as patients are reluctant to consider the possibility of stopping them and providers are reluctant to even suggest the possibility. In the course of a brief return visit in primary care, providers simply do not have the time or incentive to engage in a potentially difficult, lengthy discussion with patients about reducing or stopping their benzodiazepine.

The goal of this project is to evaluate direct patient education compared to direct patient education paired with additional support and encouragement from a care manager in order to reduce chronic benzodiazepine use. Strategies to help reduce benzodiazepine use are of great interest to providers and our findings would have significance for all providers, and may even conceivably improve the care of patient both inside and outside the Medicaid program.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • With a prescription BZD supply covering ≥20% of days in the preceding 12 months ("chronic").

排除标准

  • Patients with BZD supply <20% days in past 12 months
  • Patients with ICD-10 codes for dementia (derived from encounter diagnosis codes)
  • long-term care residents (ICD-10 codes Z59.3 and Y92.199)

结局指标

主要结局

Change in avg. daily dose of benzodiazepine prescribed in lorazepam-equivalent mg

时间窗: 6 months

Compare the average daily dose during month 6 to the baseline average daily dose

次要结局

  • Alcohol Use Disorders Identification Test (AUDIT-C)(3 months)
  • Insomnia Severity Index (ISI)(3 months)
  • PHQ-8(6 months)
  • GAD-7(6 months)
  • Patient Health Questionnaire (PHQ-8)(3 months)
  • Generalized Anxiety Disorder 7-Item Scale (GAD-7)(3 months)
  • ISI(6 months)
  • AUDIT-C(6 months)

研究者

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

Donovan Maust

Professor of Psychiatry

University of Michigan

研究点 (2)

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