iLIVE Medication Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Palliative Care

Intervention / Treatment
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* Device: CDSS-OPTIMED


Participation Criteria
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Eligibility Criteria
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Inclusion criteria for patients: Patient is 18 years or over and provides informed consent to participate. The patient is aware that recovering from his/her disease is unlikely, as assessed by the attending physician. The patient agrees to participate in the iLIVE cohort study. The attending physician would not be surprised if the patient would die within 6 months ('Surprise question'). 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: 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). 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Before-after study design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control arm<br>Patients in the control arm will receive the usual treatment | |
| Experimental: Intervention arm<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Palliative care, Medication Therapy Management, Clinical Decision Support System (CDSS), Communication