Clinical trial NCT04717882: iLIVE Medication Study
Official title: Towards Medication Optimisation in the Last Phase of Life: iLIVE Medication Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Palliative Care
Keywords: Palliative care
Medication Therapy Management
Clinical Decision Support System (CDSS)
Communication
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Lund University
name: Landspitali University Hospital
name: Medical University of Vienna
First posted: 2021-01-22
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Before-after study design
Primary purpose: SUPPORTIVE_CARE

Brief 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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patients' quality of life
timeFrame: 4 weeks after baseline assessment
Secondary outcomes:
measure: Patients' symptoms
timeFrame: 4 weeks after baseline assessment
measure: Use of medication of the patient
timeFrame: 4 weeks after baseline assessment
measure: Patient survival
timeFrame: 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
measure: Satisfaction of the patient and relative with medication
timeFrame: 4 weeks after baseline assessment
measure: Satisfaction of the attending physician with the CDSS-OPTIMED
timeFrame: 4 weeks after baseline assessment
measure: Episodes of symptomatic hypertension/hypotension/hyperglycaemia/hypoglycaemia and thrombo-embolic complications or bleeding events of the patient
timeFrame: 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
measure: Socio-demographic characteristics of the patient
timeFrame: Baseline
Other outcomes:
measure: Development and training costs of the intervention
timeFrame: Retrospectively over full study period, i.e. a period of 2 years
measure: Operational costs of the intervention
timeFrame: Retrospectively over full study period, i.e. a period of 2 years
measure: Patients' use of medical interventions
timeFrame: 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
measure: Costs of medical care
timeFrame: 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
measure: Patients' health related quality of life
timeFrame: 4 weeks after baseline assessment
measure: Patients' capabilities
timeFrame: 4 weeks after baseline assessment
measure: Patients' resource use, employment and patient activities/informal care needs
timeFrame: 4 weeks after baseline assessment
measure: Relatives' health related quality of life
timeFrame: 4 weeks after baseline assessment
measure: Relatives' capabilities
timeFrame: 4 weeks after baseline assessment
measure: Relatives' informal care provision
timeFrame: 4 weeks after baseline assessment
measure: Dutch subgroup patients' health related quality of life
timeFrame: 8 weeks after baseline assessment, repeated 4-weekly to a maximum of 24 weeks
measure: Dutch patients' capabilities
timeFrame: 8 weeks after baseline assessment, repeated 4-weekly to a maximum of 24 weeks
measure: Dutch patients' resource use, employment and patient activities/informal care needs
timeFrame: 8 weeks after baseline assessment, repeated 4-weekly to a maximum of 24 weeks
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Lund
country: Sweden
facility: Skåne University Hospital
city: Bern
country: Switzerland
facility: Bern University Hospital
Study officials:
affiliation: Erasmus Medical Center
name: Karin van der Rijt, PhD
role: PRINCIPAL_INVESTIGATOR
References: