Appropriate Medication Use in Dutch Terminal Care (AMUSE)

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

Status: Completed

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

Treatments: Device: CDSS-OPTIMED

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT05351281

NL7830507821

MEC-2021-0624 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

250 participants in 2 patient groups

Standard of care

No Intervention group

Description:

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

CDSS-OPTIMED

Experimental group

Description:

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.

Treatment:

Device: CDSS-OPTIMED