Palliative CareAMUSENCT05351281
Appropriate Medication Use in Dutch Terminal Care
A study testing CDSS-OPTIMED in people with Palliative Care and Terminal Care, run by Prof.dr Carin (C.C.D.) van der Rijt at 7 sites in Netherlands.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care, Terminal Care, Medication Therapy Management
- 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
- 250 participants
- Where
- 7 sitesNetherlands
- Study dates
- 29 Apr 2022to 20 Feb 2025
- 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 older and provides informed consent to participate.
- The patient is aware that recovering from his/her disease is unlikely, to be assessed by the attending physician.
- The patient is competent to decide about trial participation
- The patient has a life expectancy of at least two weeks and at most three months, as estimated by an attending physician.
Who cannot join
- The patient is incapable of filling in a questionnaire (patients may be supported by relatives when filling in the questionnaire).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Netherlands7 sites
Noordwest Ziekenhuisgroep
Alkmaar
Rijnstate Hospital
Arnhem
Gezondheidscentrum Krimpen
Krimpen aan den IJssel
Nijmegen University Academic Network Family Medicine
Nijmegen
Erasmus Medical Center
Rotterdam
Ikazia Hospital
Rotterdam
Laurens Cadenza Zuid
Rotterdam
About this study
Official title: Appropriate Medication USE in Dutch Terminal Care: AMUSE Trial
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.
Read the detailed description
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.
- Conditions
- Palliative Care, Terminal Care, Medication Therapy Management, Clinical Decision Support System (CDSS), Quality of Life
- Being tested
- CDSS-OPTIMED
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 with a life expectancy of less than 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | Patients in the standard of care arm will receive the usual treatment |
| CDSS-OPTIMED | Experimental | 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. 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 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
Measured: Two weeks after baseline assessment
Secondary outcomes (9)
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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: From inclusion until death, with a maximum of 24 weeks
Patient survival
Derived from patients' medical records and contact with the patient
Measured: From inclusion until death, with a maximum of 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start29 Apr 2022
- Primary completion16 Oct 2024
- Study completion20 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Crossover
- Model description
- A stepped-wedge cluster randomized study. The stepped-wedge design involves random and sequential crossover of 7 clusters (=7 different study sites) from the control to the intervention group, until all clusters are exposed. All clusters will start as control sites, where care is provided as usual. Every twelve weeks, one site will crossover from control to intervention group
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof.dr Carin (C.C.D.) van der Rijt
- Sponsor type
- University, hospital or other
- Collaborators
- Rijnstate Hospital, Ikazia Hospital, Rotterdam, Noordwest Ziekenhuisgroep, Laurens Cadenza Zuid, Nijmegen University Academic Network Family Medicine, Gezondheidscentrum Krimpen
- Responsible party
- Sponsor-investigator, Prof.dr Carin (C.C.D.) van der Rijt, Erasmus Medical Center
- Investigators
- Carin van der Rijt, Prof, MD, Principal investigator, Erasmus Medical CenterEric Geijteman, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351281
- Sponsor's protocol ID
- NL7830507821
- Other IDs
- MEC-2021-0624
- Acronym
- AMUSE
- Status last verified
- Mar 2025
- First submitted
- 11 Apr 2022
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will already be shared with the Dutch national centre of expertise and repository for research data (DANS)
Publications
van Hylckama Vlieg MAM, Pot IE, Visser HPJ, Jong MAC, van der Vorst MJDL, van Mastrigt BJ, Kiers JNA, van den Homberg PPPH, Thijs-Visser MF, Oomen-de Hoop E, van der Heide A, van der Kuy PHM, van der Rijt CCD, Geijteman ECT. Appropriate medication use in Dutch terminal care: study protocol of a multicentre stepped-wedge cluster randomized controlled trial (the AMUSE study). BMC Palliat Care. 2024 Jan 3;23(1):6. doi: 10.1186/s12904-023-01334-x.
PubMed 38172930
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appropriate Medication USE in Dutch Terminal Care: AMUSE Trial
- ClinicalTrials.gov ID
- NCT05351281
- Acronym / sponsor ID
- AMUSE / NL7830507821
- Conditions
- Palliative Care, Terminal Care, Medication Therapy Management, Clinical Decision Support System (CDSS), Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Prof.dr Carin (C.C.D.) van der RijtUniversity, hospital or other
- Collaborators
- Rijnstate Hospital, Ikazia Hospital, Rotterdam, Noordwest Ziekenhuisgroep, Laurens Cadenza Zuid, Nijmegen University Academic Network Family Medicine, Gezondheidscentrum Krimpen
- Study start
- 29 Apr 2022 (actual)
- Primary completion
- 16 Oct 2024 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 28 Apr 2022 (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 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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A stepped-wedge cluster randomized study. The stepped-wedge design involves random and sequential crossover of 7 clusters (=7 different study sites) from the control to the intervention group, until all clusters are exposed. All clusters will start as control sites, where care is provided as usual. Every twelve weeks, one site will crossover from control to intervention group
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –Patients in the standard of care arm will receive the usual treatment |
| CDSS-OPTIMED | Experimental | Device: CDSS-OPTIMEDIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is 18 years or older and provides informed consent to participate.
- The patient is aware that recovering from his/her disease is unlikely, to be assessed by the attending physician.
- The patient is competent to decide about trial participation
- The patient has a life expectancy of at least two weeks and at most three months, as estimated by an attending physician.
Key exclusion criteria (1 listed)
- The patient is incapable of filling in a questionnaire (patients may be supported by relatives when filling in the questionnaire).
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 with a life expectancy of less than 3 months. | Device | CDSS-OPTIMED |
Primary outcome
Patients' quality of life
Time frame: Two weeks after baseline assessment
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
9 secondary outcomes
Patients' quality of life
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
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)
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)
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
Time frame: From inclusion until death, with a maximum of 24 weeks
Time spent on discussing the medication with the patient
Time frame: From inclusion until death, with a maximum of 24 weeks
Health care costs
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)
Time frame: From inclusion until death, with a maximum of 24 weeks
Patient survival
Time frame: From inclusion until death, with a maximum of 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Derived from this study: PubMed 38172930van Hylckama Vlieg MAM, Pot IE, Visser HPJ, Jong MAC, van der Vorst MJDL, van Mastrigt BJ, Kiers JNA, van den Homberg PPPH, Thijs-Visser MF, Oomen-de Hoop E, van der Heide A, van der Kuy PHM, van der Rijt CCD, Geijteman ECT. Appropriate medication use in Dutch terminal care: study protocol of a multicentre stepped-wedge cluster randomized controlled trial (the AMUSE study). BMC Palliat Care. 2024 Jan 3;23(1):6. doi: 10.1186/s12904-023-01334-x.
- Individual participant dataSharing planned: No. Individual participant data will already be shared with the Dutch national centre of expertise and repository for research data (DANS)
Related trials for Palliative Care
Not yet recruitingPhase 2
Psilocybin With Psychotherapy for Improving Chronic Pain in Cancer Patients Requiring Opioids
Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
RecruitingPhase 1/2
Interstitial Photodynamic Therapy Following Palliative Radiotherapy in Treating Patients With Inoperable Malignant Central Airway Obstruction
Malignant Solid Neoplasm
Active, not recruiting
LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
Liver Disease Chronic, End Stage Liver DIsease
Not yet recruiting
Comparing Radiotherapy Dose Strategies for Symptom Relief in Large Solid Tumors
Solid Tumor
Enrolling by invitationPhase 3
Nudging Effective and Equitable Delivery of Specialty Palliative Care
Serious Illness, Palliative
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.
Carin van der Rijt, Prof, MD principal investigator
Erasmus Medical Center
Eric Geijteman, MD, PhD principal investigator
Erasmus Medical Center
7 sites in 1 country: 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 and Terminal Care, run by Prof.dr Carin (C.C.D.) van der Rijt at 7 sites in Netherlands.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients' quality of life (time frame: Two weeks after baseline assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05351281, which also lists 1 linked publication.
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 21 Mar 2025.