Appropriate Medication Use in Dutch Terminal Care

NCT ID: NCT05351281

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-29
• Study Completion Date: 2025-02-20

Brief 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 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.

Conditions

Palliative Care; Terminal Care; Medication Therapy Management; Clinical Decision Support System (CDSS); Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard of care

Patients in the standard of care arm will receive the usual treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

CDSS-OPTIMED

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.

Group Type: EXPERIMENTAL

CDSS-OPTIMED

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rijnstate Hospital

OTHER

Sponsor Role: collaborator

Ikazia Hospital, Rotterdam

OTHER

Sponsor Role: collaborator

Noordwest Ziekenhuisgroep

OTHER

Sponsor Role: collaborator

Laurens Cadenza Zuid

UNKNOWN

Sponsor Role: collaborator

Nijmegen University Academic Network Family Medicine

NETWORK

Sponsor Role: collaborator

Gezondheidscentrum Krimpen

UNKNOWN

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

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

Professor Palliative Oncology of Department Medical Oncology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Carin van der Rijt, Prof, MD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Eric Geijteman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

Noordwest Ziekenhuisgroep

Alkmaar, , Netherlands

Rijnstate Hospital

Arnhem, , Netherlands

Gezondheidscentrum Krimpen

Krimpen aan den IJssel, , Netherlands

Nijmegen University Academic Network Family Medicine

Nijmegen, , Netherlands

Erasmus Medical Center

Rotterdam, , Netherlands

Ikazia Hospital

Rotterdam, , Netherlands

Laurens Cadenza Zuid

Rotterdam, , Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 38172930 (View on PubMed)

Other Identifiers

MEC-2021-0624

Identifier Type: OTHER

Identifier Source: secondary_id

NL7830507821

Identifier Type: -

Identifier Source: org_study_id