跳至主要内容
临床试验/NCT06110156
NCT06110156Enrolling By Invitation不适用

Population Health Approach to Optimizing and Deprescribing Medications in Older Adults

Cedars-Sinai Medical Center2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年5月19日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
100
试验地点
2
主要终点
Number of all-cause hospitalizations

研究概览

简要总结

This randomized controlled pragmatic pilot study examines the feasibility and acceptability of a population health-based deprescribing intervention that leverages a polypharmacy risk prediction model. It includes four arms (2 intervention and 2 control arms) and uses a parallel arm study design.

详细描述

This pilot clinical trial will examine the feasibility and acceptability of a medication management intervention that uses risk stratification to identify older adults (including older adults with Mild Cognitive Impairment or Alzheimer's Disease and Related Dementias) at greatest risk for polypharmacy-related adverse events. The intervention will use a risk prediction model to identify potential study participants for inclusion and enroll them and their care partners into a polypharmacy clinic. The study will stratify patients by cognitive impairment status. The risk prediction model includes variables such as: age, sex, recent healthcare encounters, current and past medications, current and past lab tests, current and past diagnoses.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

  • Patients will be invited to enroll in the study if they are in the top decile of risk selected by a risk prediction model of polypharmacy-related adverse events. The risk prediction model includes variables such as: age, sex, recent healthcare encounters, current and past medications, current and past lab tests, current and past diagnoses.
  • 65 years of age or older
  • Have a primary care clinician within the Cedars-Sinai Health System who uses MyCSLink (electronic health record used by Cedars-Sinai).
  • Part of a Cedars-Sinai Health System population health registry (e.g., enrolled in an Accountable Care Organization, Medicare Advantage plan, or Primary Care First program)
  • Diagnosis of Mild Cognitive Impairment or Dementia at baseline (for one intervention group) on the problem list
  • Exclusion criteria include:
  • Patients for whom there is an active substance use disorder (defined by a physician) and thus for whom the intervention may not be appropriate
  • Patients with an organ transplant
  • Visits with a Cedars-Sinai Medical Center pharmacist for a polypharmacy consult within the last 6 months
  • Patients who previously indicated in the EHR that they wish to opt out of participating in research studies.
  • Patients enrolled in CS360, a program for highly complex medical patients, who already receive polypharmacy services.

排除标准

  • 未提供

结局指标

主要结局

Number of all-cause hospitalizations

时间窗: 12 months after enrollment

Number of all-cause inpatient visits (including observation visits) 12 months after enrollment.

次要结局

  • Total number of medications(Baseline, 12 months)
  • Total number of potentially inappropriate medications(Baseline, 12 months)
  • Number of medications with a dose reduction >10% over 12 months(12 months)
  • Number of medications discontinued for 90 days or more which are re-prescribed(Baseline, 12 months)
  • Number of times per day the patient is taking medications(Baseline, 12 months)
  • Number of potential prescribing omissions (PPOs) based on the STOPP/START criteria(12 months)
  • Number of drug-related problems(Baseline, 12 months)
  • Number of potential pharmacy recommendations(Baseline, 12 months)
  • Change in risk prediction model score(12 months)

研究者

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

Michelle Keller

Research Scientist I

Cedars-Sinai Medical Center

研究点 (2)

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