iLIVE Medication Study

Palliative Care Clinical Trial

— iLIVEmed  

Official title:

Towards Medication Optimisation in the Last Phase of Life: iLIVE Medication Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04717882
• Other study ID #: NL72473.078.20
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 15, 2021
• Est. completion date: January 15, 2024

Study information

• Verified date: January 2021
• Source: Erasmus Medical Center
• Contact: Eline Elsten, MD
• Phone: +316-51996165
• Email: e.e.c.m.elsten[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: January 15, 2024
• Est. primary completion date: January 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Palliative Care

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Erasmus Medical Center	Rotterdam
Sweden	Skåne University Hospital	Lund
Switzerland	Bern University Hospital	Bern

Sponsors (4)

Lead Sponsor	Collaborator
Prof. dr. Stefan Sleijfer	Landspitali University Hospital, Lund University, Medical University of Vienna

Countries where clinical trial is conducted

Netherlands,  Sweden,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	Patients' health related quality of life	measured by the EQ-5D-5L	4 weeks after baseline assessment
Other	Patients' capabilities	measured by the ICECAP-SCM	4 weeks after baseline assessment
Other	Patients' resource use, employment and patient activities/informal care needs	measured by the HEQ	4 weeks after baseline assessment
Other	Relatives' health related quality of life	measured by the EQ-5D-5L	4 weeks after baseline assessment
Other	Relatives' capabilities	measured by the ICECAP-CPM	4 weeks after baseline assessment
Other	Relatives' informal care provision	measured by the partial IVICQ and CIIQ	4 weeks after baseline assessment
Other	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
Other	Dutch patients' capabilities	measured by the ICECAP-SCM	8 weeks after baseline assessment, repeated 4-weekly to a maximum of 24 weeks
Other	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
Primary	Patients' quality of life	measured by the EORTC QLQ-C15-PAL QoL question	4 weeks after baseline assessment
Secondary	Patients' symptoms	measured by the ESAS	4 weeks after baseline assessment
Secondary	Use of medication of the patient	measured by the medical file data and pharmacist's information system	4 weeks after baseline assessment
Secondary	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
Secondary	Satisfaction of the patient and relative with medication	measured by the TSQM-9	4 weeks after baseline assessment
Secondary	Satisfaction of the attending physician with the CDSS-OPTIMED	measured by a self-developed questionnaire	4 weeks after baseline assessment
Secondary	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
Secondary	Socio-demographic characteristics of the patient	Age, gender, current living situation, education, nationality, religion, socioeconomic status	Baseline