Clinical trial NCT05351281: Appropriate Medication Use in Dutch Terminal Care
Official title: Appropriate Medication USE in Dutch Terminal Care: AMUSE Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Palliative Care
Terminal Care
Medication Therapy Management
Clinical Decision Support System (CDSS)
Quality of Life
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Rijnstate Hospital
name: Ikazia Hospital, Rotterdam
name: Noordwest Ziekenhuisgroep
name: Laurens Cadenza Zuid
name: Nijmegen University Academic Network Family Medicine
name: Gezondheidscentrum Krimpen
First posted: 2022-04-28
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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
Primary purpose: SUPPORTIVE_CARE

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.

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).

Primary outcomes:
measure: Patients' quality of life
timeFrame: Two weeks after baseline assessment
Secondary outcomes:
measure: Patients' quality of life
timeFrame: At day 7, 21, 28, and then every 28 days until death, with a maximum of 24 weeks,
measure: Symptoms and the occurrence of potential side effects of continuing or discontinuing medication
timeFrame: At day 1-7, 14, 21, 28, and then every 28 days until death, with a maximum of 24 weeks
measure: Systolic and Diastolic Blood Pressure (mmHg) in case of using antihypertensives (continued or discontinued)
timeFrame: At day 1-7, 14, 21, 28, and then every 28 days until death, with a maximum of 24 weeks
measure: Glucose level (mmol/L) in case of using antidiabetics (continued or discontinued)
timeFrame: At day 1-7, 14, 21, 28, and then every 28 days until death, with a maximum of 24 weeks
measure: Occurence of thrombo-embolic and bleeding events
timeFrame: From inclusion until death, with a maximum of 24 weeks
measure: Time spent on discussing the medication with the patient
timeFrame: From inclusion until death, with a maximum of 24 weeks
measure: Health care costs
timeFrame: Retrospectively over full study period (From inclusion until death, with a maximum of 24 weeks)
measure: Medication prescriptions (All medication used by the patient during te whole study period)
timeFrame: From inclusion until death, with a maximum of 24 weeks
measure: Patient survival
timeFrame: From inclusion until death, with a maximum of 24 weeks
Other outcomes:
measure: Costs of the intervention
timeFrame: Retrospectively over full study period. Full study period is from inclusion until death, with a maximum of 24 weeks.
Locations:
city: Alkmaar
country: Netherlands
facility: Noordwest Ziekenhuisgroep
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
city: Krimpen Aan Den IJssel
country: Netherlands
facility: Gezondheidscentrum Krimpen
city: Nijmegen
country: Netherlands
facility: Nijmegen University Academic Network Family Medicine
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Rotterdam
country: Netherlands
facility: Ikazia Hospital
city: Rotterdam
country: Netherlands
facility: Laurens Cadenza Zuid
Study officials:
affiliation: Erasmus Medical Center
name: Carin van der Rijt, Prof, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus Medical Center
name: Eric Geijteman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: