An interventional study of CDSS-OPTIMED in Palliative Care, Terminal Care and Medication Therapy Management, sponsored by Prof.dr Carin (C.C.D.) van der Rijt. Completed at 7 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-21.
Sponsored by Prof.dr Carin (C.C.D.) van der Rijt · Not applicable, Interventional, and Supportive care
The AMUSE trial is a multicentre stepped-wedge cluster randomized controlled trial where medication optimization of patients with a life expectancy of less than three months is investigated by using CDSS-OPTIMED (a personalized medication advice to attending physicians of patients in the last phase of life) The investigators will include 250 patients, in 7 different study sites across the Netherlands. The primary outcome is an assessment of the quality of life of patients, two weeks after baseline assessment.
Rationale: patients in the last phase of life often use many medications that are continued 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.
Primary objective: to examine whether the use of 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 endpoint is patients' quality of life two weeks after baseline assessment, as measured by the EORTC QLQ-C15-PAL questionnaire (scale 0 to 100).
Potential risks and benefits associated with participation: the intervention in this trial supports physicians in using available evidence and knowledge when 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 trial 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.
This is the only study on the registry with Prof.dr Carin (C.C.D.) van der Rijt as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients in the standard of care arm will receive the usual treatment
In the experimental arm, attending physicians will receive weekly medication alerts from the Clinical Decision Support System (CDSS) within 1 week after inclusion of the patient. The CDSS-OPTIMED will send a medication advice on a weekly basis, based on a weekly analysis of patient's medication. 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 with a life expectancy of less than 3 months.
Patients' quality of life
Measured by the quality of life question of the European Organization for Research and Treatment of Cancer Quality of Life Group 15 item core questionnaire for palliative care ( = EORTC QLQ-C15-PAL questionnaire) Scale 1 to 7. Scale minimum 1 (very poor). Scale maximum 7 (excellent). Score will be rescaled to a scale from 0 to 100, in which 100 is an excellent outcome
Time frame: Two weeks after baseline assessment
Patients' quality of life
Measured by the quality of life question of the European Organization for Research and Treatment of Cancer Quality of Life Group 15 item core questionnaire for palliative care ( = EORTC QLQ-C15-PAL questionnaire) Scale 1 to 7. Scale minimum 1 (very poor). Scale maximum 7 (excellent). Score will be rescaled to a scale from 0 to 100, in which 100 is an excellent outcome
Time frame: At day 7, 21, 28, and then every 28 days until death, with a maximum of 24 weeks,
Symptoms and the occurrence of potential side effects of continuing or discontinuing medication
Assessed by the Utrecht Symptoom Dagboek (USD, which is based on the Edmonton Symptom Assessment Scale (ESAS)) Scale 0 to 10. Scale minimum 0 (no symptoms). Scale maximum 10 (worst possible symptoms)
Time frame: At day 1-7, 14, 21, 28, and then every 28 days until death, with a maximum of 24 weeks
Systolic and Diastolic Blood Pressure (mmHg) in case of using antihypertensives (continued or discontinued)
Measured by patients' attending health care professional
Time frame: At day 1-7, 14, 21, 28, and then every 28 days until death, with a maximum of 24 weeks
Glucose level (mmol/L) in case of using antidiabetics (continued or discontinued)
Measured by patients' attending health care professional
Time frame: At day 1-7, 14, 21, 28, and then every 28 days until death, with a maximum of 24 weeks
Occurence of thrombo-embolic and bleeding events
Measured and reported in the data management system by the time between inclusion and death
Time frame: From inclusion until death, with a maximum of 24 weeks
Time spent on discussing the medication with the patient
As registered in the electronic patient files on a time scale (0-5 minutes, 6-10 minutes, 11-15 minutes, 16-20 minutes, \>21minutes) Scale minimum: 0-5 minutes (short). Scale maximum: \>21 minutes (long)
Time frame: From inclusion until death, with a maximum of 24 weeks
Health care costs
Measured by using a medical file checklist. Items to be assessed include: medication prescriptions, hospital admissions and in-hospital care
Time frame: Retrospectively over full study period (From inclusion until death, with a maximum of 24 weeks)
Medication prescriptions (All medication used by the patient during te whole study period)
Measured by using a medical file checklist in our data management system. Derived from patients' medical records and the pharmacist's information system
Time frame: From inclusion until death, with a maximum of 24 weeks
Patient survival
Derived from patients' medical records and contact with the patient
Time frame: From inclusion until death, with a maximum of 24 weeks
Costs of the intervention
Development and training costs (proformas completed by the developers and the study personnel). Operational costs (including time spent on discussing medication alerts with the pharmacist and patient/relative derived from patients' medical records. And time registrations via automated system extracts, derived from CDSS-OPTIMED)
Time frame: Retrospectively over full study period. Full study period is from inclusion until death, with a maximum of 24 weeks.
Plan to share: No — Individual participant data will already be shared with the Dutch national centre of expertise and repository for research data (DANS)
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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