iLIVE Medication Study (iLIVEmed)

• ClinicalTrials.gov Identifier: NCT04717882
• Recruitment Status: Not yet recruiting
• First Posted: January 22, 2021
• Last Update Posted: January 22, 2021
• Sponsor: Prof. dr. Stefan Sleijfer
• Collaborators: Lund University; Landspitali University Hospital; Medical University of Vienna
• Information provided by (Responsible Party): Prof. dr. Stefan Sleijfer, Erasmus Medical Center

Study Description

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

Condition or disease	Intervention/treatment	Phase
Palliative Care	Device: CDSS-OPTIMED	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 400 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: Before-after study design
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Towards Medication Optimisation in the Last Phase of Life: iLIVE Medication Study
• Estimated Study Start Date: January 15, 2021
• Estimated Primary Completion Date: January 15, 2023
• Estimated Study Completion Date: January 15, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Patients' quality of life [ Time Frame: 4 weeks after baseline assessment ]
   measured by the EORTC QLQ-C15-PAL QoL question

Secondary Outcome Measures :

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

Other Outcome Measures:

1. Development and training costs of the intervention [ Time Frame: Retrospectively over full study period, i.e. a period of 2 years ]
   Based on proformas completed by the developers and the study personnel
2. Operational costs of the intervention [ Time Frame: Retrospectively over full study period, i.e. a period of 2 years ]
   Based on time spent on discussing medication alerts with the pharmacist and patient/relative and time registrations via automated system extracts
3. Patients' use of medical interventions [ Time Frame: 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 ]
   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
4. Costs of medical care [ Time Frame: 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 ]
   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
5. Patients' health related quality of life [ Time Frame: 4 weeks after baseline assessment ]
   measured by the EQ-5D-5L
6. Patients' capabilities [ Time Frame: 4 weeks after baseline assessment ]
   measured by the ICECAP-SCM
7. Patients' resource use, employment and patient activities/informal care needs [ Time Frame: 4 weeks after baseline assessment ]
   measured by the HEQ
8. Relatives' health related quality of life [ Time Frame: 4 weeks after baseline assessment ]
   measured by the EQ-5D-5L
9. Relatives' capabilities [ Time Frame: 4 weeks after baseline assessment ]
   measured by the ICECAP-CPM
10. Relatives' informal care provision [ Time Frame: 4 weeks after baseline assessment ]
    measured by the partial IVICQ and CIIQ
11. Dutch subgroup patients' health related quality of life [ Time Frame: 8 weeks after baseline assessment, repeated 4-weekly to a maximum of 24 weeks ]
    measured by the EQ-5D-5L
12. Dutch patients' capabilities [ Time Frame: 8 weeks after baseline assessment, repeated 4-weekly to a maximum of 24 weeks ]
    measured by the ICECAP-SCM
13. Dutch patients' resource use, employment and patient activities/informal care needs [ Time Frame: 8 weeks after baseline assessment, repeated 4-weekly to a maximum of 24 weeks ]
    measured by the HEQ

Eligibility Criteria

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

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.

Contacts and Locations

Contacts

Contact: Eline Elsten, MD; +316-51996165; e.e.c.m.elsten@erasmusmc.nl

Contact: Eric Geijteman, PhD; +316-24920206; e.geijteman@erasmusmc.nl

Locations

Netherlands

Erasmus Medical Center

Rotterdam, Netherlands

Contact: Karin van der Rijt, PhD c.vanderrijt@erasmusmc.nl

Sweden

Skåne University Hospital

Lund, Sweden

Switzerland

Bern University Hospital

Bern, Switzerland

Sponsors and Collaborators

Prof. dr. Stefan Sleijfer

Lund University

Landspitali University Hospital

Medical University of Vienna

Investigators

• Principal Investigator: Karin van der Rijt, PhD; Erasmus MC

More Information

• Responsible Party: Prof. dr. Stefan Sleijfer, Drs. E.E.C.M. Elsten (executive investigator), Prof. dr. C.C.D. van der Rijt (principal investigator), Prof. dr. Sleijfer (sponsor), Erasmus Medical Center
• ClinicalTrials.gov Identifier: NCT04717882
• Other Study ID Numbers: NL72473.078.20
• First Posted: January 22, 2021
• Last Update Posted: January 22, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prof. dr. Stefan Sleijfer, Erasmus Medical Center:

Palliative care; Medication Therapy Management; Clinical Decision Support System (CDSS); Communication