iLIVE Medication Study

Not Applicable

• Conditions: Palliative Care

• Registration Number: NCT04717882
• Lead Sponsor: Prof. dr. Stefan Sleijfer

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.

Study Timeline

• Status Verified: 2021-01
• Study First Submitted: 2021-01-07
• Study Start: 2021-01-15
• Study First Submitted QC: 2021-01-18
• Last Update Submitted: 2021-01-18
• Study First Posted: 2021-01-22
• Last Update Posted: 2021-01-22
• Primary Completion: 2023-01-15
• Study Completion: 2024-01-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Patients' quality of life	4 weeks after baseline assessment	measured by the EORTC QLQ-C15-PAL QoL question

Secondary Outcome Measures

Name	Time	Method
Patient survival	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
Satisfaction of the patient and relative with medication	4 weeks after baseline assessment	measured by the TSQM-9
Socio-demographic characteristics of the patient	Baseline	Age, gender, current living situation, education, nationality, religion, socioeconomic status
Satisfaction of the attending physician with the CDSS-OPTIMED	4 weeks after baseline assessment	measured by a self-developed questionnaire
Episodes of symptomatic hypertension/hypotension/hyperglycaemia/hypoglycaemia and thrombo-embolic complications or bleeding events of the patient	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
Use of medication of the patient	4 weeks after baseline assessment	measured by the medical file data and pharmacist's information system
Patients' symptoms	4 weeks after baseline assessment	measured by the ESAS

Trial Locations

Locations (3)

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands

Skåne University Hospital; 🇸🇪 Lund, Sweden

Bern University Hospital; 🇨🇭 Bern, Switzerland