Appropriate Medication Use in Dutch Terminal Care

Quality of Life Clinical Trial

— AMUSE  

Official title:

Appropriate Medication USE in Dutch Terminal Care: AMUSE Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05351281
• Other study ID #: NL7830507821
• Secondary ID: MEC-2021-0624
• Status: Recruiting
• Phase: N/A
• Start date: April 29, 2022
• Est. completion date: August 2024

Study information

• Verified date: February 2024
• Source: Erasmus Medical Center
• Contact: Marte van Hylckama Vlieg, MD
• Phone: +31648857686
• Email: m.vanhylckamavlieg[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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).

Related Conditions & MeSH terms

• Medication Therapy Management
• Palliative Care
• Quality of Life
• Terminal Care

Intervention

Device:
• 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.

Locations

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

Sponsors (7)

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

Country where clinical trial is conducted

Netherlands, 

Outcome

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