Appropriate Medication Use in Dutch Terminal Care (AMUSE)

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Palliative Care; Medication Therapy Management; Terminal Care; Clinical Decision Support System (CDSS)
• Intervention / Treatment: Device: CDSS-OPTIMED

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.

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marte van Hylckama Vlieg, MD; Phone Number: +31648857686; Email: m.vanhylckamavlieg@erasmusmc.nl
• Study Contact Backup: Name: Eric Geijteman, MD, PhD; Phone Number: +31650031026; Email: e.geijteman@erasmusmc.nl

Study Locations

• Netherlands
  • Alkmaar, Netherlands
    • Recruiting
    • Noordwest Ziekenhuisgroep
  • Arnhem, Netherlands
    • Recruiting
    • Rijnstate Hospital
  • Krimpen Aan Den IJssel, Netherlands
    • Recruiting
    • Gezondheidscentrum Krimpen
  • Nijmegen, Netherlands
    • Recruiting
    • Nijmegen University Academic Network Family Medicine
  • Rotterdam, Netherlands
    • Recruiting
    • Erasmus Medical Center
  • Rotterdam, Netherlands
    • Recruiting
    • Ikazia Hospital
  • Rotterdam, Netherlands
    • Recruiting
    • Laurens Cadenza Zuid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of care; Patients in the standard of care arm will receive the usual treatment
Experimental: CDSS-OPTIMED; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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,
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
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
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
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
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
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)
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
Patient survival	Derived from patients' medical records and contact with the patient	From inclusion until death, with a maximum of 24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Prof.dr Carin (C.C.D.) van der Rijt
• Collaborators: Noordwest Ziekenhuisgroep; Rijnstate Hospital; Ikazia Hospital, Rotterdam; Laurens Cadenza Zuid; Nijmegen University Academic Network Family Medicine; Gezondheidscentrum Krimpen
• Investigators: Principal Investigator: Carin van der Rijt, Prof, MD, Erasmus Medical Center; Principal Investigator: Eric Geijteman, MD, PhD, Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2022
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: April 11, 2022
• First Submitted That Met QC Criteria: April 22, 2022
• First Posted (Actual): April 28, 2022

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: NL7830507821; MEC-2021-0624 (Other Identifier: Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will already be shared with the Dutch national centre of expertise and repository for research data (DANS)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No