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NCT Number: NCT05351281

Appropriate Medication Use in Dutch Terminal 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Noordwest Ziekenhuisgroep, Alkmaar, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • The patient is incapable of filling in a questionnaire (patients may be supported by relatives when filling in the questionnaire).

Treatment and study plan

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 with a life expectancy of less than 3 months.

Primary outcomes

  1. 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

Secondary outcomes

  1. Patients' quality of life

    Time frame: At day 7, 21, 28, and then every 28 days until death, with a maximum of 24 weeks,

    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

  2. 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

    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)

  3. 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

    Measured by patients' attending health care professional

  4. 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

    Measured by patients' attending health care professional

  5. Occurence of thrombo-embolic and bleeding events

    Time frame: From inclusion until death, with a maximum of 24 weeks

    Measured and reported in the data management system by the time between inclusion and death

  6. Time spent on discussing the medication with the patient

    Time frame: From inclusion until death, with a maximum of 24 weeks

    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)

  7. Health care costs

    Time frame: Retrospectively over full study period (From inclusion until death, with a maximum of 24 weeks)

    Measured by using a medical file checklist. Items to be assessed include: medication prescriptions, hospital admissions and in-hospital care

  8. 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

    Measured by using a medical file checklist in our data management system. Derived from patients' medical records and the pharmacist's information system

  9. Patient survival

    Time frame: From inclusion until death, with a maximum of 24 weeks

    Derived from patients' medical records and contact with the patient

Other outcomes

  1. Costs of the intervention

    Time frame: Retrospectively over full study period. Full study period is from inclusion until death, with a maximum of 24 weeks.

    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)

Sponsors and collaborators

Lead sponsor

Prof.dr Carin (C.C.D.) van der Rijt

Other

Collaborators

  • Gezondheidscentrum Krimpen
  • Ikazia Hospital, Rotterdam
  • Laurens Cadenza Zuid
  • Nijmegen University Academic Network Family Medicine
  • Noordwest Ziekenhuisgroep
  • Rijnstate Hospital

Registry information

Official study title

Appropriate Medication USE in Dutch Terminal Care: AMUSE Trial

Acronym: AMUSE

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Apr 28, 2022
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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