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| Name | Class |
|---|---|
| Lund University | OTHER |
| Landspitali University Hospital | OTHER |
| Medical University of Vienna | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CDSS-OPTIMED | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Patients' quality of life | measured by the EORTC QLQ-C15-PAL QoL question | 4 weeks after baseline assessment |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Development and training costs of the intervention | Based on proformas completed by the developers and the study personnel | Retrospectively over full study period, i.e. a period of 2 years |
| Operational costs of the intervention |
Inclusion criteria for patients:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eline Elsten, MD | Contact | +316-51996165 | e.e.c.m.elsten@erasmusmc.nl | |
| Eric Geijteman, PhD | Contact | +316-24920206 | e.geijteman@erasmusmc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Karin van der Rijt, PhD | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus Medical Center | Rotterdam | Netherlands |
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| ID | Term |
|---|---|
| D003142 | Communication |
| ID | Term |
|---|---|
| D001519 | Behavior |
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Before-after study design
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| 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 |
Based on time spent on discussing medication alerts with the pharmacist and patient/relative and time registrations via automated system extracts
| Retrospectively over full study period, i.e. a period of 2 years |
| Patients' use of medical interventions | 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 | 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 |
| Costs of medical care | 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 | 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 |
| Patients' health related quality of life | measured by the EQ-5D-5L | 4 weeks after baseline assessment |
| Patients' capabilities | measured by the ICECAP-SCM | 4 weeks after baseline assessment |
| Patients' resource use, employment and patient activities/informal care needs | measured by the HEQ | 4 weeks after baseline assessment |
| Relatives' health related quality of life | measured by the EQ-5D-5L | 4 weeks after baseline assessment |
| Relatives' capabilities | measured by the ICECAP-CPM | 4 weeks after baseline assessment |
| Relatives' informal care provision | measured by the partial IVICQ and CIIQ | 4 weeks after baseline assessment |
| Dutch subgroup patients' health related quality of life | measured by the EQ-5D-5L | 8 weeks after baseline assessment, repeated 4-weekly to a maximum of 24 weeks |
| Dutch patients' capabilities | measured by the ICECAP-SCM | 8 weeks after baseline assessment, repeated 4-weekly to a maximum of 24 weeks |
| Dutch patients' resource use, employment and patient activities/informal care needs | measured by the HEQ | 8 weeks after baseline assessment, repeated 4-weekly to a maximum of 24 weeks |
| Skåne University Hospital | Lund | Sweden |
| Bern University Hospital | Bern | Switzerland |