跳至主要内容
临床试验/NCT05147428
NCT05147428已完成不适用

D- PRESCRIBE-AD (The Developing a PRogram to Educate and Sensitize Caregivers to Reduce the Inappropriate Prescription Burden in Elderly With Alzheimer's Disease Study)

University of Massachusetts, Worcester2 个研究点 分布在 1 个国家目标入组 14,442 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
14,442
试验地点
2
主要终点
Time to Dispensing of Inappropriate Medication Prescription

研究概览

简要总结

Potentially inappropriate prescribing includes the use of medications that may no longer be necessary or that may increase the risk of harm. Inappropriate prescribing can increase the overall symptom burden, and negatively affect health-related quality of life and function. The inappropriate prescription of certain drug categories such as sedative/hypnotics, antipsychotics, and strong anticholinergic agents poses particular risks for older adults, and may be more common among those with Alzheimer's disease and Alzheimer's disease- related dementias (AD/ADRD) due to a higher prevalence of multimorbidity and more frequent prescription of five or more medications. The D-PRESCRIBE-AD (Developing a PRogram to Educate and Sensitize Caregivers to Reduce the Inappropriate Prescription Burden in Elderly with Alzheimer's Disease) study will test a health plan-based intervention using the NIH Collaboratory's Distributed Research Network, which employs the Food and Drug Administration (FDA) Sentinel System infrastructure. The overarching goal of this randomized controlled trial is to assess the effect of a patient/caregiver- centered, multifaceted educational intervention on potentially inappropriate prescribing in patients with AD/ADRD. The research hypothesis is that education on inappropriate prescribing among patients/caregivers and their providers can reduce medication-related morbidity in patients with AD/ADRD and improve medication safety for this vulnerable population. The study population will include community-dwelling patients with AD/ADRD, identified based on diagnoses codes of AD/ADRD or use of a medication for Alzheimer's Disease, who have evidence of potentially inappropriate prescribing the three drug classes above. The trial will evaluate the effect of educational interventions designed to spur patient/caregiver-provider communication about medication safety (versus usual care) on the proportion of patients with inappropriate prescribing, the primary outcome of this study. The trial will be conducted in two large, national health plans.

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

入选标准

  • Patient Inclusion Criteria:
  • Diagnosis of AD/ADRD based on a combination of AD/ADRD codes or treatment with a pharmacologic therapy used for AD (e.g., donepezil, rivastigmine, galantamine, and memantine) in the 365 days prior to or on cohort entry date.
  • Evidence of potentially inappropriate prescribing with antipsychotics, sedative-hypnotics, and strong anticholinergics within the past 3 months
  • Age ≥50 years of age as of cohort entry date
  • Continuous medical and pharmacy insurance coverage for at least the prior year

排除标准

  • Evidence of residing in a nursing home or skilled nursing facility or receiving palliative care.
  • Incomplete/missing prescriber ID or incomplete contact information for either patient or prescribing provider.
  • On "do not contact" list

结局指标

主要结局

Time to Dispensing of Inappropriate Medication Prescription

时间窗: 6 months

The primary outcome will be defined as dispensing of the targeted inappropriate prescription class from day 91 to day 270 during the 6 months observation period following receipt of intervention, or days 91-270.

次要结局

  • Dose Reduction(6 months)
  • Percentage of Participants With Polypharmacy(6 months)
  • Percentage of Participants With Ambulatory Encounters(6 months)
  • Percentage of Participants Who Died(6 months)
  • Switching Within Classes(6 months)
  • Percentage of Participants With Emergency Department Encounters(6 months)
  • Percentage of Participants With Hospitalizations(6 months)
  • Percentage of Participants With Non-acute Institutional Admissions(6 months)

研究者

发起方
University of Massachusetts, Worcester
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jerry Gurwitz

Professor of Medicine, Family Medicine and Community Health, and Population & Quantitative Health Sciences Chief, Division of Geriatric Medicine UMass Chan Medical School and UMass Memorial Medical Center Executive Director, Meyers Health Care Institute

University of Massachusetts, Worcester

研究点 (2)

Loading locations...

相似试验