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iLIVE Medication Study (iLIVEmed)

18 stycznia 2021 zaktualizowane przez: 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

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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 studiów

Interwencyjne

Zapisy (Oczekiwany)

400

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie podtrzymujące
  • Przydział: Nielosowe
  • Model interwencyjny: Zadanie sekwencyjne
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Brak interwencji: Control arm
Patients in the control arm will receive the usual treatment
Eksperymentalny: 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.
Urządzenie: 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 mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Patients' quality of life
Ramy czasowe: 4 weeks after baseline assessment
measured by the EORTC QLQ-C15-PAL QoL question
4 weeks after baseline assessment

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Patients' symptoms
Ramy czasowe: 4 weeks after baseline assessment
measured by the ESAS
4 weeks after baseline assessment
Use of medication of the patient
Ramy czasowe: 4 weeks after baseline assessment
measured by the medical file data and pharmacist's information system
4 weeks after baseline assessment
Patient survival
Ramy czasowe: 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
Ramy czasowe: 4 weeks after baseline assessment
measured by the TSQM-9
4 weeks after baseline assessment
Satisfaction of the attending physician with the CDSS-OPTIMED
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Baseline
Age, gender, current living situation, education, nationality, religion, socioeconomic status
Baseline

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Development and training costs of the intervention
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 4 weeks after baseline assessment
measured by the EQ-5D-5L
4 weeks after baseline assessment
Patients' capabilities
Ramy czasowe: 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
Ramy czasowe: 4 weeks after baseline assessment
measured by the HEQ
4 weeks after baseline assessment
Relatives' health related quality of life
Ramy czasowe: 4 weeks after baseline assessment
measured by the EQ-5D-5L
4 weeks after baseline assessment
Relatives' capabilities
Ramy czasowe: 4 weeks after baseline assessment
measured by the ICECAP-CPM
4 weeks after baseline assessment
Relatives' informal care provision
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Prof. dr. Stefan Sleijfer

Współpracownicy

Lund University
Medical University of Vienna
Landspitali University Hospital

Śledczy

  • Główny śledczy: Karin van der Rijt, PhD, Erasmus MC

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Oczekiwany)

15 stycznia 2021

Zakończenie podstawowe (Oczekiwany)

15 stycznia 2023

Ukończenie studiów (Oczekiwany)

15 stycznia 2024

Daty rejestracji na studia

Pierwszy przesłany

7 stycznia 2021

Pierwszy przesłany, który spełnia kryteria kontroli jakości

18 stycznia 2021

Pierwszy wysłany (Rzeczywisty)

22 stycznia 2021

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

22 stycznia 2021

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

18 stycznia 2021

Ostatnia weryfikacja

1 stycznia 2021

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • NL72473.078.20

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAk

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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