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
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (予想される)
400
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Eline Elsten, MD
- 電話番号：+316-51996165
- メール：e.e.c.m.elsten@erasmusmc.nl
研究連絡先のバックアップ
- 名前：Eric Geijteman, PhD
- 電話番号：+316-24920206
- メール：e.geijteman@erasmusmc.nl
研究場所
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Rotterdam、オランダ
- Erasmus Medical Center
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コンタクト：
- Karin van der Rijt, PhD
- メール：c.vanderrijt@erasmusmc.nl
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Bern、スイス
- Bern University Hospital
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Lund、スウェーデン
- Skane University Hospital
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：非ランダム化
- 介入モデル：順次割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：Control arm
Patients in the control arm will receive the usual treatment
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Patients' quality of life
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Patients' symptoms
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Baseline
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Age, gender, current living situation, education, nationality, religion, socioeconomic status
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Baseline
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Development and training costs of the intervention
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Karin van der Rijt, PhD、Erasmus MC
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (予想される)
2021年1月15日
一次修了 (予想される)
2023年1月15日
研究の完了 (予想される)
2024年1月15日
試験登録日
最初に提出
2021年1月7日
QC基準を満たした最初の提出物
2021年1月18日
最初の投稿 (実際)
2021年1月22日
学習記録の更新
投稿された最後の更新 (実際)
2021年1月22日
QC基準を満たした最後の更新が送信されました
2021年1月18日
最終確認日
2021年1月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- NL72473.078.20
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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