Palliative CareiLIVEmedNCT04717882
iLIVE Medication Study
A study testing CDSS-OPTIMED in people with Palliative Care, run by Prof. dr. Stefan Sleijfer at 3 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care
- What is being tested?
- CDSS-OPTIMED
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 15 Jan 2021to 15 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Netherlands1 site
Erasmus Medical Center
Rotterdam
Karin van der Rijt, PhD, c.vanderrijt@erasmusmc.nl
About this study
Official title: Towards Medication Optimisation in the Last Phase of Life: iLIVE Medication Study
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
Read the 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.
- Conditions
- Palliative Care
- Being tested
- CDSS-OPTIMED
- Keywords
- Palliative care, Medication Therapy Management, Clinical Decision Support System (CDSS), Communication
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDSS-OPTIMEDDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Control arm | No intervention | Patients in the control arm will receive the usual treatment |
| Intervention arm | Experimental | 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. Receives: Device: CDSS-OPTIMED |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' quality of life
measured by the EORTC QLQ-C15-PAL QoL question
Measured: 4 weeks after baseline assessment
Secondary outcomes (7)
Patients' symptoms
measured by the ESAS
Measured: 4 weeks after baseline assessment
Use of medication of the patient
measured by the medical file data and pharmacist's information system
Measured: 4 weeks after baseline assessment
Patient survival
measured by the time between inclusion until death
Measured: 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
Measured: 4 weeks after baseline assessment
Satisfaction of the attending physician with the CDSS-OPTIMED
measured by a self-developed questionnaire
Measured: 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
Measured: 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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start15 Jan 2021 (estimated)
- Primary completion15 Jan 2023 (estimated)
- Study completion15 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Before-after study design
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. dr. Stefan Sleijfer
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University, Landspitali University Hospital, Medical University of Vienna
- Responsible party
- Sponsor-investigator, Prof. dr. Stefan Sleijfer, Erasmus Medical Center
- Investigators
- Karin van der Rijt, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04717882
- Sponsor's protocol ID
- NL72473.078.20
- Acronym
- iLIVEmed
- Status last verified
- Jan 2021
- First submitted
- 7 Jan 2021
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards Medication Optimisation in the Last Phase of Life: iLIVE Medication Study
- ClinicalTrials.gov ID
- NCT04717882
- Acronym / sponsor ID
- iLIVEmed / NL72473.078.20
- Conditions
- Palliative Care
- Keywords
- Palliative care, Medication Therapy Management, Clinical Decision Support System (CDSS), Communication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Prof. dr. Stefan SleijferUniversity, hospital or other
- Collaborators
- Lund University, Landspitali University Hospital, Medical University of Vienna
- Study start
- 15 Jan 2021 (estimated)
- Primary completion
- 15 Jan 2023 (estimated)
- Study completion
- 15 Jan 2024 (estimated)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Before-after study design
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –Patients in the control arm will receive the usual treatment |
| Intervention arm | Experimental | Device: CDSS-OPTIMEDAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CDSS-OPTIMEDThe 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. | Device | Intervention arm |
Primary outcome
Patients' quality of life
Time frame: 4 weeks after baseline assessment
measured by the EORTC QLQ-C15-PAL QoL question
7 secondary outcomes
Patients' symptoms
Time frame: 4 weeks after baseline assessment
Use of medication of the patient
Time frame: 4 weeks after baseline assessment
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
Satisfaction of the patient and relative with medication
Time frame: 4 weeks after baseline assessment
Satisfaction of the attending physician with the CDSS-OPTIMED
Time frame: 4 weeks after baseline assessment
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
Socio-demographic characteristics of the patient
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin van der Rijt, PhD principal investigator
Erasmus Medical Center
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CDSS-OPTIMED in people with Palliative Care, run by Prof. dr. Stefan Sleijfer at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands, Sweden, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eline Elsten, MD (+316-51996165, e.e.c.m.elsten@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients' quality of life (time frame: 4 weeks after baseline assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.