Quality of Life Clinical Trial
— AMUSEOfficial title:
Appropriate Medication USE in Dutch Terminal Care: AMUSE Trial
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.
Status | Recruiting |
Enrollment | 250 |
Est. completion date | August 2024 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
Netherlands | 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 |
Lead Sponsor | Collaborator |
---|---|
Prof.dr Carin (C.C.D.) van der Rijt | Gezondheidscentrum Krimpen, Ikazia Hospital, Rotterdam, Laurens Cadenza Zuid, Nijmegen University Academic Network Family Medicine, Noordwest Ziekenhuisgroep, Rijnstate Hospital |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Costs of the intervention | 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) |
Retrospectively over full study period. Full study period is from inclusion until death, with a maximum of 24 weeks. | |
Primary | 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 |
Two weeks after baseline assessment | |
Secondary | 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 |
At day 7, 21, 28, and then every 28 days until death, with a maximum of 24 weeks, | |
Secondary | 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) |
At day 1-7, 14, 21, 28, and then every 28 days until death, with a maximum of 24 weeks | |
Secondary | Systolic and Diastolic Blood Pressure (mmHg) in case of using antihypertensives (continued or discontinued) | Measured by patients' attending health care professional | At day 1-7, 14, 21, 28, and then every 28 days until death, with a maximum of 24 weeks | |
Secondary | Glucose level (mmol/L) in case of using antidiabetics (continued or discontinued) | Measured by patients' attending health care professional | At day 1-7, 14, 21, 28, and then every 28 days until death, with a maximum of 24 weeks | |
Secondary | Occurence of thrombo-embolic and bleeding events | Measured and reported in the data management system by the time between inclusion and death | From inclusion until death, with a maximum of 24 weeks | |
Secondary | 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) | From inclusion until death, with a maximum of 24 weeks | |
Secondary | Health care costs | Measured by using a medical file checklist. Items to be assessed include: medication prescriptions, hospital admissions and in-hospital care | Retrospectively over full study period (From inclusion until death, with a maximum of 24 weeks) | |
Secondary | 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 | From inclusion until death, with a maximum of 24 weeks | |
Secondary | Patient survival | Derived from patients' medical records and contact with the patient | From inclusion until death, with a maximum of 24 weeks |
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