此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Medication Use and Quality of Life Among Older People (Pilot)

2022年4月19日 更新者:Carina Lundby、Odense University Hospital
This project will provide new evidence on how to optimize medication use among older people with limited life expectancy. This will be done by testing whether a patient-centered deprescribing intervention, focused on aligning medical treatment with patients' preferences, can improve quality of life among older people with limited life expectancy. This registration concerns the initial pilot study.

研究概览

地位

完全的

详细说明

In a pragmatic randomized controlled trial, this project will test whether a comprehensive and patient-centered deprescribing intervention can improve quality of life among older people with limited life expectancy. This registration concerns the initial pilot study. All patients included in the pilot study will receive the intervention (that is, the pilot study will not include randomization).

The intervention will comprise a series of consultations between the patient and general practitioner (GP) (at least three) to continuously adjust the patient's medication according to the patient's goals, needs, and preferences, thereby ensuring alignment with the patient's priorities. Thus, the purpose of this intervention is to initiate and facilitate a continued deprescribing process. The process can be summarized in seven steps: During an initial consultation (1: Consultation 0), the GP assesses patient eligibility. If the patient would like to participate, a project nurse subsequently visits the patient at home (2: Home visit) for retrieval of informed consent as well as baseline measurements. During the next consultation (3: Consultation 1), the patient and GP discuss how the patient feels about his/her medical treatment, and the GP provides the patient with written material for the patient to prepare prior to the next consultation. The patients prepares (4: Preparation) by considering and verbalizing his/her goals of care and treatment preferences. Simultaneously, a clinical pharmacist examines the patient's medication list and provides suggestions to the GP on which drugs can be continued and deprescribed, respectively. During the next consultation (5: Consultation 2), the patient and GP discuss the patient's preferences and initiate deprescribing initiatives aligned with the patient's priorities. During a new consultation (6: Consultation 3), the patient and GP follow up on the changes initiated and initiate new deprescribing initiatives if such can be identified. If needed, subsequent consultations (7: Consultation X) are planned until the patient and GP consider the patient's medical treatment optimal.

研究类型

介入性

注册 (实际的)

3

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Region Of Southern Denmark
      • Odense、Region Of Southern Denmark、丹麦、5000
        • Odense University Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

80年 及以上 (年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion criteria:

  • Aged ≥80 years
  • Take ≥8 different medications
  • Have a life expectancy of <2 years, estimated via the Surprise Question ("Would you be surprised if this patient died within 1-2 years?") by the general practitioner
  • Have a Mini-Mental State Exam (MMSE) score of ≥15
  • Are able to provide informed consent

Exclusion Criteria:

  • Not able to communicate
  • Does not speak and understand Danish

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
其他:Consultations
The intervention will comprise a series of consultations between the patient and general practitioner (at least three), where the patient and general practitioner will continuously adjust the patient's medication according to the patient's goals, needs, and preferences.
The intervention will comprise a series of consultations between the patient and general practitioner (at least three), where the patient and general practitioner will continuously adjust the patient's medication according to the patient's goals, needs, and preferences.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
HEALTH-RELATED QUALITY OF LIFE
大体时间:Baseline
Health-related quality of life will be measured using the Danish version of the SF-12v2 Health Survey.
Baseline
CHANGE FROM BASELINE HEALTH-RELATED QUALITY OF LIFE AT 3 MONTHS
大体时间:3 months
Health-related quality of life will be measured using the Danish version of the SF-12v2 Health Survey.
3 months
CHANGE FROM BASELINE HEALTH-RELATED QUALITY OF LIFE AT 6 MONTHS
大体时间:6 months
Health-related quality of life will be measured using the Danish version of the SF-12v2 Health Survey.
6 months
HEALTH-RELATED QUALITY OF LIFE (DEPRESSION)
大体时间:Baseline
Health-related quality of life will be measured using the Danish version of the Depression List.
Baseline
CHANGE FROM BASELINE HEALTH-RELATED QUALITY OF LIFE (DEPRESSION) AT 3 MONTHS
大体时间:3 months
Health-related quality of life will be measured using the Danish version of the Depression List.
3 months
CHANGE FROM BASELINE HEALTH-RELATED QUALITY OF LIFE (DEPRESSION) AT 6 MONTHS
大体时间:6 months
Health-related quality of life will be measured using the Danish version of the Depression List.
6 months
MORTALITY
大体时间:3 months
Mortality will be assessed through the nationwide Danish Central Person Registry.
3 months
MORTALITY
大体时间:6 months
Mortality will be assessed through the nationwide Danish Central Person Registry.
6 months
MORTALITY
大体时间:12 months
Mortality will be assessed through the nationwide Danish Central Person Registry.
12 months

次要结果测量

结果测量
措施说明
大体时间
功能级别
大体时间:基线、3个月和6个月
功能水平将使用丹麦版弱势老年人调查 13 (VES-13) 进行测量。
基线、3个月和6个月
握力
大体时间:基线、3个月和6个月
将使用手握力计测量手握力。
基线、3个月和6个月
药物变化次数
大体时间:3个月、6个月和12个月
药物变化的数量将通过药物清单进行评估。
3个月、6个月和12个月
COGNITIVE FUNCTION
大体时间:Baseline, 3 months and 6 months
Cognitive function will be measured using the Danish version of the Mini-Mental State Examination-2 (MMSE-2) Standard Form.
Baseline, 3 months and 6 months
ABILITY TO SIT AND STAND
大体时间:Baseline, 3 months and 6 months
Ability to sit and stand will be measured via the 30-second stand-sit-test.
Baseline, 3 months and 6 months
NUMBER OF MEDICATIONS DISCONTINUED
大体时间:3 months, 6 months and 12 months
Number of medications dicontinued will be assessed through the medication lists.
3 months, 6 months and 12 months
HOSPITAL ADMISSIONS
大体时间:3 months, 6 months and 12 months
Admissions will be assessed through the nationwide Danish National Patient Register.
3 months, 6 months and 12 months
HEALTH CARE COSTS
大体时间:3 months, 6 months and 12 months
Health care costs.
3 months, 6 months and 12 months
SUCCESS RATE OF THE INTERVENTION
大体时间:3 months, 6 months and 12 months
Succes rate of the intervention.
3 months, 6 months and 12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Anton Pottegård, Prof、apottegaard@health.sdu.dk

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年6月1日

初级完成 (实际的)

2021年4月12日

研究完成 (实际的)

2021年7月8日

研究注册日期

首次提交

2020年12月1日

首先提交符合 QC 标准的

2020年12月18日

首次发布 (实际的)

2020年12月21日

研究记录更新

最后更新发布 (实际的)

2022年4月26日

上次提交的符合 QC 标准的更新

2022年4月19日

最后验证

2022年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • ODIN-1 Pilot

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅