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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
250
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.
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
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
Time frame: Two weeks after baseline assessment
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
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
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)
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)
Measured by patients' attending health care professional
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)
Measured by patients' attending health care professional
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
Measured and reported in the data management system by the time between inclusion and death
Time frame: 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)
Time frame: 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
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)
Measured by using a medical file checklist in our data management system. Derived from patients' medical records and the pharmacist's information system
Time frame: From inclusion until death, with a maximum of 24 weeks
Patient survival
Derived from patients' medical records and contact with the patient
Time frame: From inclusion until death, with a maximum of 24 weeks
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