- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT04717882
iLIVE Medication Study (iLIVEmed)
Towards Medication Optimisation in the Last Phase of Life: iLIVE Medication Study
Обзор исследования
Подробное описание
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.
Тип исследования
Регистрация (Ожидаемый)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Eline Elsten, MD
- Номер телефона: +316-51996165
- Электронная почта: e.e.c.m.elsten@erasmusmc.nl
Учебное резервное копирование контактов
- Имя: Eric Geijteman, PhD
- Номер телефона: +316-24920206
- Электронная почта: e.geijteman@erasmusmc.nl
Места учебы
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Rotterdam, Нидерланды
- Erasmus Medical Center
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Контакт:
- Karin van der Rijt, PhD
- Электронная почта: c.vanderrijt@erasmusmc.nl
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Bern, Швейцария
- Bern University Hospital
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Lund, Швеция
- Skåne University Hospital
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Нерандомизированный
- Интервенционная модель: Последовательное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Без вмешательства: Control arm
Patients in the control arm will receive the usual treatment
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Экспериментальный: 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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Patients' quality of life
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Patients' symptoms
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: Baseline
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Age, gender, current living situation, education, nationality, religion, socioeconomic status
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Baseline
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Development and training costs of the intervention
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Karin van der Rijt, PhD, Erasmus MC
Даты записи исследования
Изучение основных дат
Начало исследования (Ожидаемый)
Первичное завершение (Ожидаемый)
Завершение исследования (Ожидаемый)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- NL72473.078.20
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
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