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临床试验/NCT03722017
NCT03722017已完成不适用

Drug Reduction in Older Patients: The DROP Trial

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2019年10月7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
260
试验地点
2
主要终点
Total Number of Medications

研究概览

简要总结

Project Objectives: The proposed randomized, controlled trial will evaluate the effects of procedures to reduce medications among hospitalized older Veterans discharged to nursing homes using an hybrid study design to inform future efforts to spread it across VA.

Project Background/Rationale: Patients discharged to nursing homes for short stays represent the largest group of Medicare beneficiaries discharged to post-hospital services and are a particularly high risk group for loss of independence and other poor clinical outcomes. This investigative team recently completed a VA-funded Quality Improvement Award and a Centers for Medicare and Medicaid Services (CMS) Innovation Award, both of which provide strong results related to the occurrence of polypharmacy and the relationship between polypharmacy and geriatric syndromes (e.g., medications associated with falls) in this patient population. Based on these data, the investigators developed and pilot-tested a patient-centered deprescribing set of procedures combined with standardized questions for eight geriatric syndromes to be implemented in the hospital and monitored during the nursing home stay.

Project Methods: The investigators propose an innovative hybrid study design that will be conducted in one VA hospital. The goal of the proposed DROP intervention is to safely deprescribe medications, as defined by reducing doses or stopping medications, based on a combination of clinical criteria and Veteran preferences. This randomized, controlled trial conducted over three years will evaluate the effects of this hospital-based intervention on medication use, geriatric syndromes, and health status across Veterans' care transitions from the hospital to nursing home to home to include a 90-day follow-up period after leaving the nursing home. The hypothesis is that reducing medications for older Veterans will favorably impact geriatric syndromes. Additionally, the investigators aim to understand Veteran, both VA and non-VA provider and system-level factors that help or hinder how well the deprescribing procedures are implemented to inform future clinical uptake and dissemination throughout the VA.

详细描述

Overview and Specific Aims Polypharmacy, defined as five or more medications, is common in older patients discharged to skilled nursing facilities (SNFs) and is associated with adverse health outcomes. As part of a recent VA project, the investigators prospectively collected medication data for 134 hospitalized, older Veterans. These data showed that, on average, 14.2 medications were ordered for Veterans discharged to SNF, which included 2.5 medications newly prescribed in the hospital that met criteria for being potentially inappropriate medications (PIMs). Moreover, 75% of these Veterans had two or more geriatric syndromes. Geriatric syndromes are clinical conditions common in older adults such as cognitive impairment, unintentional weight loss and falls. The co-occurrence of multiple syndromes is associated with loss of independence and higher healthcare utilization. All Veterans with polypharmacy also had one or more medications associated with geriatric syndromes. The prevalence of polypharmacy and multiple geriatric syndromes may partially explain why these patients often have poor health outcomes after SNF discharge. Recent data suggests that only 28% of patients discharged from SNF are living at home 100 days later, and 35% experience an adverse drug event.

There is a dearth of evidence related to the management of multiple co-existing geriatric syndromes, and few interventions have been implemented to reduce medications while also monitoring health outcomes. The relationship between polypharmacy, adverse drug events and geriatric syndromes in the VA population supports the rationale for an intervention focused on deprescribing medications before hospital discharge. The investigators have pilot-tested a multifaceted intervention (Drug Reduction in Older Patients, DROP) to engage patients and providers to reduce the number and/or dose of medications prior to hospital discharge. The proposed randomized, controlled trial is powered to evaluate the effect of this intervention on a reduction in medications as defined by the total number of prescribed medications, the number of PIMs, anticholinergic and sedative drug burden and the number of medications associated with geriatric syndromes. In addition, the investigators will collect relevant data on the prevalence and severity of geriatric syndromes and other clinical outcomes. The investigators also will use a hybrid research design to evaluate both effectiveness and implementation issues to better inform future adoption and sustainability. Our overarching hypothesis is that a hospital-based intervention to safely reduce the total number of medications represents the most feasible way to impact multiple health-related outcomes among older Veterans. Our Specific Aims reflect the primary outcomes that are the focus of the analyses, although the investigators also will measure secondary outcomes related to VA healthcare utilization and patient safety:

Specific Aim 1: Implement a patient-centered deprescribing intervention (DROP) in the hospital to reduce the total number of medications Veterans are prescribed at hospital discharge.

Specific Aim 2: Document the effects of a Veteran-centered deprescribing intervention (DROP) on medication adherence, health status, and geriatric syndromes.

Specific Aim 3: Evaluate intervention implementation to inform future adoption and sustainability.

研究设计

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

盲法说明

The participant and providers involved in their care will not be masked to the intervention, as there is participation of both groups in the deprescribing protocol discussions.

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

  • Referred to SNF (per Physical Therapy and/or Social Work notes)
  • Being discharged from the Nashville VA hospital from a medicine or orthopedics team
  • Age > or = 50
  • Have polypharmacy, as defined by > 5 medications based on pre-hospital and in-hospital medications
  • Able to self-consent or has a surrogate

排除标准

  • Resides in long-term care
  • On hospice
  • Not expected to discharge within 48 hours of referral

结局指标

主要结局

Total Number of Medications

时间窗: Hospital Discharge, SNF Discharge, and 90-days after SNF Discharge

The number of medications a participant is taking. This includes all prescribed and over-the-counter medications and both scheduled and as-needed (PRN) medications.

次要结局

  • Total Drug Burden Index (DBI): Anticholinergic and Sedative Drug Burden(Hospital Discharge, SNF Discharge, and 90 Days after SNF Discharge)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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Drug Reduction in Older Patients: The DROP Trial | 临床试验