Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

iLIVE Medication Study (iLIVEmed)

18. ledna 2021 aktualizováno: 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

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Očekávaný)

400

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion criteria for patients:

  1. Patient is 18 years or over and provides informed consent to participate.
  2. The patient is aware that recovering from his/her disease is unlikely, as assessed by the attending physician.
  3. The patient agrees to participate in the iLIVE cohort study.
  4. The attending physician would not be surprised if the patient would die within 6 months ('Surprise question').
  5. 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:

  1. 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).
  2. 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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Podpůrná péče
  • Přidělení: Nerandomizované
  • Intervenční model: Sekvenční přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Žádný zásah: Control arm
Patients in the control arm will receive the usual treatment
Experimentální: 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.
Přístroj: CDSS-OPTIMED
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Patients' quality of life
Časové okno: 4 weeks after baseline assessment
measured by the EORTC QLQ-C15-PAL QoL question
4 weeks after baseline assessment

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Patients' symptoms
Časové okno: 4 weeks after baseline assessment
measured by the ESAS
4 weeks after baseline assessment
Use of medication of the patient
Časové okno: 4 weeks after baseline assessment
measured by the medical file data and pharmacist's information system
4 weeks after baseline assessment
Patient survival
Časové okno: 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
measured by the time between inclusion until death
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
Časové okno: 4 weeks after baseline assessment
measured by the TSQM-9
4 weeks after baseline assessment
Satisfaction of the attending physician with the CDSS-OPTIMED
Časové okno: 4 weeks after baseline assessment
measured by a self-developed questionnaire
4 weeks after baseline assessment
Episodes of symptomatic hypertension/hypotension/hyperglycaemia/hypoglycaemia and thrombo-embolic complications or bleeding events of the patient
Časové okno: 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
collected via medical file data, using a pre-structured checklist
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
Socio-demographic characteristics of the patient
Časové okno: Baseline
Age, gender, current living situation, education, nationality, religion, socioeconomic status
Baseline

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Development and training costs of the intervention
Časové okno: Retrospectively over full study period, i.e. a period of 2 years
Based on proformas completed by the developers and the study personnel
Retrospectively over full study period, i.e. a period of 2 years
Operational costs of the intervention
Časové okno: Retrospectively over full study period, i.e. a period of 2 years
Based on time spent on discussing medication alerts with the pharmacist and patient/relative and time registrations via automated system extracts
Retrospectively over full study period, i.e. a period of 2 years
Patients' use of medical interventions
Časové okno: 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
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
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
Costs of medical care
Časové okno: 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
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
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
Patients' health related quality of life
Časové okno: 4 weeks after baseline assessment
measured by the EQ-5D-5L
4 weeks after baseline assessment
Patients' capabilities
Časové okno: 4 weeks after baseline assessment
measured by the ICECAP-SCM
4 weeks after baseline assessment
Patients' resource use, employment and patient activities/informal care needs
Časové okno: 4 weeks after baseline assessment
measured by the HEQ
4 weeks after baseline assessment
Relatives' health related quality of life
Časové okno: 4 weeks after baseline assessment
measured by the EQ-5D-5L
4 weeks after baseline assessment
Relatives' capabilities
Časové okno: 4 weeks after baseline assessment
measured by the ICECAP-CPM
4 weeks after baseline assessment
Relatives' informal care provision
Časové okno: 4 weeks after baseline assessment
measured by the partial IVICQ and CIIQ
4 weeks after baseline assessment
Dutch subgroup patients' health related quality of life
Časové okno: 8 weeks after baseline assessment, repeated 4-weekly to a maximum of 24 weeks
measured by the EQ-5D-5L
8 weeks after baseline assessment, repeated 4-weekly to a maximum of 24 weeks
Dutch patients' capabilities
Časové okno: 8 weeks after baseline assessment, repeated 4-weekly to a maximum of 24 weeks
measured by the ICECAP-SCM
8 weeks after baseline assessment, repeated 4-weekly to a maximum of 24 weeks
Dutch patients' resource use, employment and patient activities/informal care needs
Časové okno: 8 weeks after baseline assessment, repeated 4-weekly to a maximum of 24 weeks
measured by the HEQ
8 weeks after baseline assessment, repeated 4-weekly to a maximum of 24 weeks

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Prof. dr. Stefan Sleijfer

Spolupracovníci

Lund University
Medical University of Vienna
Landspitali University Hospital

Vyšetřovatelé

  • Vrchní vyšetřovatel: Karin van der Rijt, PhD, Erasmus MC

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Očekávaný)

15. ledna 2021

Primární dokončení (Očekávaný)

15. ledna 2023

Dokončení studie (Očekávaný)

15. ledna 2024

Termíny zápisu do studia

První předloženo

7. ledna 2021

První předloženo, které splnilo kritéria kontroly kvality

18. ledna 2021

První zveřejněno (Aktuální)

22. ledna 2021

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

22. ledna 2021

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

18. ledna 2021

Naposledy ověřeno

1. ledna 2021

Více informací

Termíny související s touto studií

Klíčová slova

Další identifikační čísla studie

  • NL72473.078.20

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

Ano

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Paliativní péče

Klinické studie na CDSS-OPTIMED

Prohledejte podobné pokusy

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Norway

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

Předplatit