Appropriate Medication USE in Dutch Terminal Care: AMUSE Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 8
- 主要终点
- Patients' quality of life
研究概览
简要总结
The AMUSE trial is a multicentre stepped-wedge cluster randomized controlled trial where medication optimization of patients with a life expectancy of less than three months is investigated by using CDSS-OPTIMED (a personalized medication advice to attending physicians of patients in the last phase of life) The investigators will include 250 patients, in 7 different study sites across the Netherlands. The primary outcome is an assessment of the quality of life of patients, two weeks after baseline assessment.
详细描述
Rationale: patients in the last phase of life often use many medications that are continued 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.
Primary objective: to examine whether the use of 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 endpoint is patients' quality of life two weeks after baseline assessment, as measured by the EORTC QLQ-C15-PAL questionnaire (scale 0 to 100).
Potential risks and benefits associated with participation: the intervention in this trial supports physicians in using available evidence and knowledge when 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 trial 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
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Sites will crossover from control to the intervention group in a random order. During the study all parties have knowledge of the interventions assigned to individual participants
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
- •Patient is 18 years or older and provides informed consent to participate.
- •The patient is aware that recovering from his/her disease is unlikely, to be assessed by the attending physician.
- •The patient is competent to decide about trial participation
- •The patient has a life expectancy of at least two weeks and at most three months, as estimated by an attending physician.
排除标准
- •The patient is incapable of filling in a questionnaire (patients may be supported by relatives when filling in the questionnaire).
研究组 & 干预措施
Standard of care
Patients in the standard of care arm will receive the usual treatment
CDSS-OPTIMED
In the experimental arm, attending physicians will receive weekly medication alerts from the Clinical Decision Support System (CDSS) within 1 week after inclusion of the patient. The CDSS-OPTIMED will send a medication advice on a weekly basis, based on a weekly analysis of patient's medication. 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: Two weeks after baseline assessment
Measured by the quality of life question of the European Organization for Research and Treatment of Cancer Quality of Life Group 15 item core questionnaire for palliative care ( = EORTC QLQ-C15-PAL questionnaire) Scale 1 to 7. Scale minimum 1 (very poor). Scale maximum 7 (excellent). Score will be rescaled to a scale from 0 to 100, in which 100 is an excellent outcome
次要结局
- Patients' quality of life(At day 7, 21, 28, and then every 28 days until death, with a maximum of 24 weeks,)
- Time spent on discussing the medication with the patient(From inclusion until death, with a maximum of 24 weeks)
- Patient survival(From inclusion until death, with a maximum of 24 weeks)
- Occurence of thrombo-embolic and bleeding events(From inclusion until death, with a maximum of 24 weeks)
- Health care costs(Retrospectively over full study period (From inclusion until death, with a maximum of 24 weeks))
- Systolic and Diastolic Blood Pressure (mmHg) in case of using antihypertensives (continued or discontinued)(At day 1-7, 14, 21, 28, and then every 28 days until death, with a maximum of 24 weeks)
- Medication prescriptions (All medication used by the patient during te whole study period)(From inclusion until death, with a maximum of 24 weeks)
- Symptoms and the occurrence of potential side effects of continuing or discontinuing medication(At day 1-7, 14, 21, 28, and then every 28 days until death, with a maximum of 24 weeks)
- Glucose level (mmol/L) in case of using antidiabetics (continued or discontinued)(At day 1-7, 14, 21, 28, and then every 28 days until death, with a maximum of 24 weeks)
研究者
Prof.dr Carin (C.C.D.) van der Rijt
Professor Palliative Oncology of Department Medical Oncology
Erasmus Medical Center