Appropriate Medication Use in Dutch Terminal Care

NCT05351281 | Completed

• 2 other identifiers: NL7830507821MEC-2021-0624
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 7

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.

Conditions

Palliative Care; Terminal Care; Medication Therapy Management; Clinical Decision Support System (CDSS); Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Patients' quality of life

  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

  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)

  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)

  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

  From inclusion until death, with a maximum of 24 weeks

Other Outcomes (1)

• Costs of the intervention

  Retrospectively over full study period. Full study period is from inclusion until death, with a maximum of 24 weeks.

Study Arms (2)

Standard of care

NO INTERVENTION

Patients in the standard of care arm will receive the usual treatment

CDSS-OPTIMED

EXPERIMENTAL

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

Interventions

CDSS-OPTIMED DEVICE

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.

CDSS-OPTIMED

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• The patient is incapable of filling in a questionnaire (patients may be supported by relatives when filling in the questionnaire).

Sponsors & Collaborators

• Prof.dr Carin (C.C.D.) van der Rijt: lead
• Rijnstate Hospital: collaborator
• Ikazia Hospital, Rotterdam: collaborator
• Noordwest Ziekenhuisgroep: collaborator
• Laurens Cadenza Zuid: collaborator
• Nijmegen University Academic Network Family Medicine: collaborator
• Gezondheidscentrum Krimpen: collaborator

Study Sites (7)

Noordwest Ziekenhuisgroep

Alkmaar, Netherlands

Location

Rijnstate Hospital

Arnhem, Netherlands

Location

Gezondheidscentrum Krimpen

Krimpen aan den IJssel, Netherlands

Location

Nijmegen University Academic Network Family Medicine

Nijmegen, Netherlands

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

Ikazia Hospital

Rotterdam, Netherlands

Location

Laurens Cadenza Zuid

Rotterdam, Netherlands

Location

Related Publications (1)

• van Hylckama Vlieg MAM, Pot IE, Visser HPJ, Jong MAC, van der Vorst MJDL, van Mastrigt BJ, Kiers JNA, van den Homberg PPPH, Thijs-Visser MF, Oomen-de Hoop E, van der Heide A, van der Kuy PHM, van der Rijt CCD, Geijteman ECT. Appropriate medication use in Dutch terminal care: study protocol of a multicentre stepped-wedge cluster randomized controlled trial (the AMUSE study). BMC Palliat Care. 2024 Jan 3;23(1):6. doi: 10.1186/s12904-023-01334-x.

  PMID: 38172930 DERIVED

Study Officials

• Carin van der Rijt, Prof, MD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

• Eric Geijteman, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Sites will crossover from control to the intervention group in a random order. During the study all parties have knowledge of the interventions assigned to individual participants
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Palliative Oncology of Department Medical Oncology

Model Details: 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

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 28, 2022
• Study Start: April 29, 2022
• Primary Completion: October 16, 2024
• Study Completion: February 20, 2025
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (7)