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iLIVE Medication Study (iLIVEmed)

18 gennaio 2021 aggiornato da: 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

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

400

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione sequenziale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: Control arm
Patients in the control arm will receive the usual treatment
Sperimentale: 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.
Dispositivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Patients' quality of life
Lasso di tempo: 4 weeks after baseline assessment
measured by the EORTC QLQ-C15-PAL QoL question
4 weeks after baseline assessment

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Patients' symptoms
Lasso di tempo: 4 weeks after baseline assessment
measured by the ESAS
4 weeks after baseline assessment
Use of medication of the patient
Lasso di tempo: 4 weeks after baseline assessment
measured by the medical file data and pharmacist's information system
4 weeks after baseline assessment
Patient survival
Lasso di tempo: 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
Lasso di tempo: 4 weeks after baseline assessment
measured by the TSQM-9
4 weeks after baseline assessment
Satisfaction of the attending physician with the CDSS-OPTIMED
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline
Age, gender, current living situation, education, nationality, religion, socioeconomic status
Baseline

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Development and training costs of the intervention
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 4 weeks after baseline assessment
measured by the EQ-5D-5L
4 weeks after baseline assessment
Patients' capabilities
Lasso di tempo: 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
Lasso di tempo: 4 weeks after baseline assessment
measured by the HEQ
4 weeks after baseline assessment
Relatives' health related quality of life
Lasso di tempo: 4 weeks after baseline assessment
measured by the EQ-5D-5L
4 weeks after baseline assessment
Relatives' capabilities
Lasso di tempo: 4 weeks after baseline assessment
measured by the ICECAP-CPM
4 weeks after baseline assessment
Relatives' informal care provision
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Prof. dr. Stefan Sleijfer

Collaboratori

Lund University
Medical University of Vienna
Landspitali University Hospital

Investigatori

  • Investigatore principale: Karin van der Rijt, PhD, Erasmus MC

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Anticipato)

15 gennaio 2021

Completamento primario (Anticipato)

15 gennaio 2023

Completamento dello studio (Anticipato)

15 gennaio 2024

Date di iscrizione allo studio

Primo inviato

7 gennaio 2021

Primo inviato che soddisfa i criteri di controllo qualità

18 gennaio 2021

Primo Inserito (Effettivo)

22 gennaio 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 gennaio 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 gennaio 2021

Ultimo verificato

1 gennaio 2021

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • NL72473.078.20

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Sì

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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