iLIVE Medication Study (iLIVEmed)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Palliative Care
• Intervention / Treatment: Device: CDSS-OPTIMED

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eline Elsten, MD; Phone Number: +316-51996165; Email: e.e.c.m.elsten@erasmusmc.nl
• Study Contact Backup: Name: Eric Geijteman, PhD; Phone Number: +316-24920206; Email: e.geijteman@erasmusmc.nl

Study Locations

• Netherlands
  • Rotterdam, Netherlands
    • Erasmus Medical Center
    • Contact: Karin van der Rijt, PhD; Email: c.vanderrijt@erasmusmc.nl
• Sweden
  • Lund, Sweden
    • Skåne University Hospital
• Switzerland
  • Bern, Switzerland
    • Bern University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control arm; Patients in the control arm will receive the usual treatment
Experimental: 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients' quality of life	measured by the EORTC QLQ-C15-PAL QoL question	4 weeks after baseline assessment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients' symptoms	measured by the ESAS	4 weeks after baseline assessment
Use of medication of the patient	measured by the medical file data and pharmacist's information system	4 weeks after baseline assessment
Patient survival	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	measured by the TSQM-9	4 weeks after baseline assessment
Satisfaction of the attending physician with the CDSS-OPTIMED	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	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	Age, gender, current living situation, education, nationality, religion, socioeconomic status	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Development and training costs of the intervention	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	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	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	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	measured by the EQ-5D-5L	4 weeks after baseline assessment
Patients' capabilities	measured by the ICECAP-SCM	4 weeks after baseline assessment
Patients' resource use, employment and patient activities/informal care needs	measured by the HEQ	4 weeks after baseline assessment
Relatives' health related quality of life	measured by the EQ-5D-5L	4 weeks after baseline assessment
Relatives' capabilities	measured by the ICECAP-CPM	4 weeks after baseline assessment
Relatives' informal care provision	measured by the partial IVICQ and CIIQ	4 weeks after baseline assessment
Dutch subgroup patients' health related quality of life	measured by the EQ-5D-5L	8 weeks after baseline assessment, repeated 4-weekly to a maximum of 24 weeks
Dutch patients' capabilities	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	measured by the HEQ	8 weeks after baseline assessment, repeated 4-weekly to a maximum of 24 weeks

Collaborators and Investigators

• Sponsor: Prof. dr. Stefan Sleijfer
• Collaborators: Lund University; Medical University of Vienna; Landspitali University Hospital
• Investigators: Principal Investigator: Karin van der Rijt, PhD, Erasmus MC

Study record dates

Study Major Dates

• Study Start (Anticipated): January 15, 2021
• Primary Completion (Anticipated): January 15, 2023
• Study Completion (Anticipated): January 15, 2024

Study Registration Dates

• First Submitted: January 7, 2021
• First Submitted That Met QC Criteria: January 18, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 18, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Palliative care; Medication Therapy Management; Communication; Clinical Decision Support System (CDSS)
• Other Study ID Numbers: NL72473.078.20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No