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临床试验/NCT06731361
NCT06731361招募中不适用

Improving Medication Prescription in the contExt of Advance Care Planning for paTients Receiving Long Term nUrSing Home Care

Amsterdam UMC, location VUmc14 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2024年9月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
450
试验地点
14
主要终点
Potential under- and overprescribing

研究概览

简要总结

Research aim:

To investigate the effect of training health care professionals in medication assessments on the medication use of nursing home residents with a limited life expectancy (< 1.5-2 years).

The core of the training is to tailor medication use to (palliative) treatment goals of nursing home residents.

Design:

A cluster randomized controlled trial on long term care wards in nursing homes, with the nursing home care organisations as unit of randomisation. The investigators intent to include 6 organisations and 450 nursing home patients. The research starts in september and lasts 1 year and 3 months. Eligible patients are nursing home patients of 65 years and older with a limited life expectancy (< 1.5-2 year) of long term care wards.

Intervention:

The intervention includes a method in which healthcare professionals (medical practitioner, pharmacist and care worker) are trained to tailor medication to the (palliative) treatment goals of nursing home patients with a limited life expectancy. The training consists of 2 components: 1) medication assessment, and 2) advance care planning (ACP). In the intervention group, healthcare professionals receive the training in combination with supporting tools and educational materials, in the control group care continues as normal. The allocation ratio for control and intervention groups is 1:1. A process evaluation will take place simultaneously with the intervention study. Data collection takes place before the start of the intervention (T0), after 6 months (T1) and after 12 months (T2).

Outcome measures:

The primary outcome measure is potential under- and over-treatment with medication. The secondary outcome measure is experienced involvement in decision-making (measured with a short questionnaire based on the revised PATD (patients' attitude towards deprescribing)). Tertiary outcome measures are: quality of life, deaths, falls, hospital admissions/acute first aid referrals and pain.

Discussion:

The intervention is expected to result in a decrease in chronic and preventive medication prescriptions, an increase in medication for symptom treatment and more involvement (and satisfaction) of the nursing home resident in decision-making, without adverse effects.

详细描述

Additional information on the method:

We included 2 nursinghome organizations in september, 2 in october, and 3 in november.

研究设计

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

盲法说明

Not possible due to the type of intervention

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

  • Nursing home patients:
  • Age 65years and above
  • Living at long term care wards in nursing homes
  • Living at a long term care ward for at least 4 weeks before start of the study

排除标准

  • Temporary nursing home patients (i.e. geriatric rehabilitation or end-of-life/hospice care)
  • Life expectancy < 4 weeks
  • Life expectancy clearly > 1.5 - 2 years (i.e. patients with Huntingtons disease)

结局指标

主要结局

Potential under- and overprescribing

时间窗: at baseline - 6 months - 12 months

Potential under- and overprescribing

次要结局

  • Experienced involvement in decision-making(At baseline and 2-4 weeks after the medication review)

研究者

发起方
Amsterdam UMC, location VUmc
申办方类型
Other
责任方
Principal Investigator
主要研究者

Martin Smalbrugge

Principal investigator, professor of Medicine for Older People and chair of the Department of Medicine for Older People

Amsterdam UMC, location VUmc

研究点 (14)

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