iLIVE Medication Study (iLIVEmed)
2021年1月18日 更新者：Prof. dr. Stefan Sleijfer
Towards Medication Optimisation in the Last Phase of Life: iLIVE Medication Study
The iLIVE medication study is a before-after study where medication optimisation of patients with an estimated life expectancy of six months is investigated.
The investigators will include 400 patients in 3 countries.
The primary outcome is an assessment of the quality of life of patients, four weeks after baseline assessment
研究概览
详细说明
Rationale: Patients in the last phase of life often use many medications until shortly before they die. This is partly inevitable, because these patients often experience multiple distressing symptoms. However, for a considerable number of medications currently often used at the end of life, the benefit is debatable, e.g. because they are aimed at the long-term prevention of illness.
Objective: the primary objective is to examine whether the use of a clinical decision support system (CDSS-OPTIMED), a personalized medication advice to attending physicians of patients in the last phase of life, contributes to patients' quality of life.
Main study endpoints: the primary outcome is an assessment of the quality of life of patients, four weeks after baseline assessment
Potential risks and benefits associated with participation: the intervention in the medication study supports physicians in using available evidence and knowledge when prescribing or deprescribing medication for patients in the last phase of life. The intervention does not involve experimental treatment or medication. The investigators expect no other risks than known side effects of (stopping) medications. The investigators are aware that the study population concerns vulnerable people who may experience fluctuating symptoms and levels of suffering across their disease trajectory. The investigators acknowledge the risk of overburdening participants. If patients feel burdened by participating in the study, they are encouraged to indicate that.
研究类型
介入性
注册 (预期的)
400
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。
学习联系方式
- 姓名：Eline Elsten, MD
- 电话号码：+316-51996165
- 邮箱：e.e.c.m.elsten@erasmusmc.nl
研究联系人备份
- 姓名：Eric Geijteman, PhD
- 电话号码：+316-24920206
- 邮箱：e.geijteman@erasmusmc.nl
学习地点
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Lund、瑞典
- Skane University Hospital
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Bern、瑞士
- Bern University Hospital
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Rotterdam、荷兰
- Erasmus Medical Center
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接触：
- Karin van der Rijt, PhD
- 邮箱：c.vanderrijt@erasmusmc.nl
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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
18年 及以上 (成人、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 for patients:
- Patient is 18 years or over and provides informed consent to participate.
- The patient is aware that recovering from his/her disease is unlikely, as assessed by the attending physician.
- The patient agrees to participate in the iLIVE cohort study.
- The attending physician would not be surprised if the patient would die within 6 months ('Surprise question').
- If the physician is uncertain about the surprise question, the patient is eligible if presenting with at least one SPICT indicator. The SPICT™ is a tool to help professionals identify people with general indicators of poor or deteriorating health and clinical signs of life-limiting conditions for assessment and care planning, based on general or disease-specific indicators.
Inclusion criteria for relative/informal caregiver of included patients:
Relatives of included patients are asked to participate if they are: 18 years or over and provide informed consent to participate; aware that it is unlikely that the patient will recover from his/her disease; and capable of filling in a questionnaire in the country's main language or in English.
Exclusion Criteria:
- The patient is incapable of filling in a questionnaire in the country's main language or in English (patients may be supported by relatives when filling in the questionnaire).
- The attending physician makes the decision that the patient should not be included in the study due to e.g. illness burden, fast deterioration or imminent death, lack of trusting relationship with the physician.
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：支持治疗
- 分配：非随机化
- 介入模型：顺序分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：Control arm
Patients in the control arm will receive the usual treatment
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实验性的：Intervention arm
After crossing over to the intervention period, attending physicians will receive medication alerts from the Clinical Decision Support System (CDSS) within 1 week after inclusion of the patient.
The medication alerts will be sent to the physician's email address.
The physician is free to follow or ignore the advice in the alerts.
If the physicians thinks these alerts are relevant for the patient, the physician will discuss these alerts with the patient and/or relatives.
After this conversation, the physician will prescribe or deprescribe medications based on the alerts.
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The CDSS-OPTIMED is a software program that provides the physician with a personalized alert on whether to consider stopping or starting medication for a specific patient.
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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 |
|---|---|---|
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Patients' quality of life
大体时间：4 weeks after baseline assessment
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measured by the EORTC QLQ-C15-PAL QoL question
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4 weeks after baseline assessment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Patients' symptoms
大体时间：4 weeks after baseline assessment
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measured by the ESAS
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4 weeks after baseline assessment
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Use of medication of the patient
大体时间：4 weeks after baseline assessment
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measured by the medical file data and pharmacist's information system
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4 weeks after baseline assessment
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Patient survival
大体时间：From inclusion until death if patients die within the study period. If patient do not die within the study period, they will be followed up to a maximum of the full study period, i.e. a period of 2 years after start of the study
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measured by the time between inclusion until death
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From inclusion until death if patients die within the study period. If patient do not die within the study period, they will be followed up to a maximum of the full study period, i.e. a period of 2 years after start of the study
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Satisfaction of the patient and relative with medication
大体时间：4 weeks after baseline assessment
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measured by the TSQM-9
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4 weeks after baseline assessment
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Satisfaction of the attending physician with the CDSS-OPTIMED
大体时间：4 weeks after baseline assessment
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measured by a self-developed questionnaire
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4 weeks after baseline assessment
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Episodes of symptomatic hypertension/hypotension/hyperglycaemia/hypoglycaemia and thrombo-embolic complications or bleeding events of the patient
大体时间：If patients die within 6 months after inclusion, data will be collected retrospectively from baseline until death. If patients live longer than 6 months, data will be collected retrospectively from baseline until 6 months after baseline
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collected via medical file data, using a pre-structured checklist
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If patients die within 6 months after inclusion, data will be collected retrospectively from baseline until death. If patients live longer than 6 months, data will be collected retrospectively from baseline until 6 months after baseline
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Socio-demographic characteristics of the patient
大体时间：Baseline
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Age, gender, current living situation, education, nationality, religion, socioeconomic status
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Baseline
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Development and training costs of the intervention
大体时间：Retrospectively over full study period, i.e. a period of 2 years
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Based on proformas completed by the developers and the study personnel
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Retrospectively over full study period, i.e. a period of 2 years
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Operational costs of the intervention
大体时间：Retrospectively over full study period, i.e. a period of 2 years
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Based on time spent on discussing medication alerts with the pharmacist and patient/relative and time registrations via automated system extracts
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Retrospectively over full study period, i.e. a period of 2 years
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Patients' use of medical interventions
大体时间：If patients die within 6 months after inclusion, data will be collected retrospectively from baseline until death. If patients live longer than 6 months, data will be collected retrospectively from baseline until 6 months after baseline
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Measured by using a pre-structured checklist.
Items to be assessed include: place of care, medical events and complications, medication use, medical and surgical interventions, goals of care statements, resuscitation policy, non-treatment decisions
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If patients die within 6 months after inclusion, data will be collected retrospectively from baseline until death. If patients live longer than 6 months, data will be collected retrospectively from baseline until 6 months after baseline
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Costs of medical care
大体时间：If patients die within 6 months after inclusion, data will be collected retrospectively from baseline until death. If patients live longer than 6 months, data will be collected retrospectively from baseline until 6 months after baseline
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Measured by using a pre-structured checklist.
Items to be assessed include: place of care, medical events and complications, medication use, medical and surgical interventions, goals of care statements, resuscitation policy, non-treatment decisions
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If patients die within 6 months after inclusion, data will be collected retrospectively from baseline until death. If patients live longer than 6 months, data will be collected retrospectively from baseline until 6 months after baseline
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Patients' health related quality of life
大体时间：4 weeks after baseline assessment
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measured by the EQ-5D-5L
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4 weeks after baseline assessment
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Patients' capabilities
大体时间：4 weeks after baseline assessment
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measured by the ICECAP-SCM
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4 weeks after baseline assessment
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Patients' resource use, employment and patient activities/informal care needs
大体时间：4 weeks after baseline assessment
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measured by the HEQ
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4 weeks after baseline assessment
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Relatives' health related quality of life
大体时间：4 weeks after baseline assessment
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measured by the EQ-5D-5L
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4 weeks after baseline assessment
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Relatives' capabilities
大体时间：4 weeks after baseline assessment
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measured by the ICECAP-CPM
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4 weeks after baseline assessment
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Relatives' informal care provision
大体时间：4 weeks after baseline assessment
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measured by the partial IVICQ and CIIQ
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4 weeks after baseline assessment
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Dutch subgroup patients' health related quality of life
大体时间：8 weeks after baseline assessment, repeated 4-weekly to a maximum of 24 weeks
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measured by the EQ-5D-5L
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8 weeks after baseline assessment, repeated 4-weekly to a maximum of 24 weeks
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Dutch patients' capabilities
大体时间：8 weeks after baseline assessment, repeated 4-weekly to a maximum of 24 weeks
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measured by the ICECAP-SCM
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8 weeks after baseline assessment, repeated 4-weekly to a maximum of 24 weeks
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Dutch patients' resource use, employment and patient activities/informal care needs
大体时间：8 weeks after baseline assessment, repeated 4-weekly to a maximum of 24 weeks
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measured by the HEQ
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8 weeks after baseline assessment, repeated 4-weekly to a maximum of 24 weeks
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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：Karin van der Rijt, PhD、Erasmus MC
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 (预期的)
2021年1月15日
初级完成 (预期的)
2023年1月15日
研究完成 (预期的)
2024年1月15日
研究注册日期
首次提交
2021年1月7日
首先提交符合 QC 标准的
2021年1月18日
首次发布 (实际的)
2021年1月22日
研究记录更新
最后更新发布 (实际的)
2021年1月22日
上次提交的符合 QC 标准的更新
2021年1月18日
最后验证
2021年1月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- NL72473.078.20
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
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.