Towards Medication Optimisation in the Last Phase of Life: iLIVE Medication Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 3
- 主要终点
- Patients' quality of life
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Control arm
Patients in the control arm will receive the usual treatment
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.
干预措施: CDSS-OPTIMED (Device)
结局指标
主要结局
Patients' quality of life
时间窗: 4 weeks after baseline assessment
measured by the EORTC QLQ-C15-PAL QoL question
次要结局
- Patients' symptoms(4 weeks after baseline assessment)
- Satisfaction of the attending physician with the CDSS-OPTIMED(4 weeks after baseline assessment)
- Patient survival(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)
- Satisfaction of the patient and relative with medication(4 weeks after baseline assessment)
- Socio-demographic characteristics of the patient(Baseline)
- Episodes of symptomatic hypertension/hypotension/hyperglycaemia/hypoglycaemia and thrombo-embolic complications or bleeding events of the patient(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)
- Use of medication of the patient(4 weeks after baseline assessment)
研究者
Prof. dr. Stefan Sleijfer
Drs. E.E.C.M. Elsten (executive investigator), Prof. dr. C.C.D. van der Rijt (principal investigator), Prof. dr. Sleijfer (sponsor)
Erasmus Medical Center