iLIVE Medication Study

NCT04717882 | Unknown DMC

• 1 other identifier: NL72473.078.20
• Study Type: interventional
• Target: 400
• Locations: 3 countries
• Sites: 3

Brief Summary

The iLIVE medication study is a before-after study where medication optimisation of patients with an estimated life expectancy of six months is investigated. The investigators will include 400 patients in 3 countries. The primary outcome is an assessment of the quality of life of patients, four weeks after baseline assessment

Conditions

Palliative Care

Keywords

Palliative care; Medication Therapy Management; Clinical Decision Support System (CDSS); Communication

Outcome Measures

Primary Outcomes (1)

• Patients' quality of life

  measured by the EORTC QLQ-C15-PAL QoL question

  4 weeks after baseline assessment

Secondary Outcomes (7)

• Patients' symptoms

  4 weeks after baseline assessment

• Use of medication of the patient

  4 weeks after baseline assessment

• Patient survival

  From inclusion until death if patients die within the study period. If patient do not die within the study period, they will be followed up to a maximum of the full study period, i.e. a period of 2 years after start of the study

• Satisfaction of the patient and relative with medication

  4 weeks after baseline assessment

• Satisfaction of the attending physician with the CDSS-OPTIMED

  4 weeks after baseline assessment

Other Outcomes (13)

• Development and training costs of the intervention

  Retrospectively over full study period, i.e. a period of 2 years

• Operational costs of the intervention

  Retrospectively over full study period, i.e. a period of 2 years

• Patients' use of medical interventions

  If patients die within 6 months after inclusion, data will be collected retrospectively from baseline until death. If patients live longer than 6 months, data will be collected retrospectively from baseline until 6 months after baseline

Study Arms (2)

Control arm

NO INTERVENTION

Patients in the control arm will receive the usual treatment

Intervention arm

EXPERIMENTAL

After crossing over to the intervention period, attending physicians will receive medication alerts from the Clinical Decision Support System (CDSS) within 1 week after inclusion of the patient. 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.

Intervention arm

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 over and provides informed consent to participate.
• The patient is aware that recovering from his/her disease is unlikely, as assessed by the attending physician.
• The patient agrees to participate in the iLIVE cohort study.
• The attending physician would not be surprised if the patient would die within 6 months ('Surprise question').
• If the physician is uncertain about the surprise question, the patient is eligible if presenting with at least one SPICT indicator. The SPICT™ is a tool to help professionals identify people with general indicators of poor or deteriorating health and clinical signs of life-limiting conditions for assessment and care planning, based on general or disease-specific indicators.
• Relatives of included patients are asked to participate if they are: 18 years or over and provide informed consent to participate; aware that it is unlikely that the patient will recover from his/her disease; and capable of filling in a questionnaire in the country's main language or in English.

You may not qualify if:

• The patient is incapable of filling in a questionnaire in the country's main language or in English (patients may be supported by relatives when filling in the questionnaire).
• The attending physician makes the decision that the patient should not be included in the study due to e.g. illness burden, fast deterioration or imminent death, lack of trusting relationship with the physician.

Sponsors & Collaborators

• Prof. dr. Stefan Sleijfer: lead
• Lund University: collaborator
• Landspitali University Hospital: collaborator
• Medical University of Vienna: collaborator

Study Sites (3)

Erasmus Medical Center

Rotterdam, Netherlands

Location

Skåne University Hospital

Lund, Sweden

Location

Bern University Hospital

Bern, Switzerland

Location

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Karin van der Rijt, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eline Elsten, MD

CONTACT

+316-51996165; e.e.c.m.elsten@erasmusmc.nl

Eric Geijteman, PhD

CONTACT

+316-24920206; e.geijteman@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Drs. E.E.C.M. Elsten (executive investigator), Prof. dr. C.C.D. van der Rijt (principal investigator), Prof. dr. Sleijfer (sponsor)

Model Details: Before-after study design

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: January 22, 2021
• Study Start: January 15, 2021
• Primary Completion: January 15, 2023
• Study Completion: January 15, 2024
• Last Updated: January 22, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share

Locations

CH (1); NL (1); SE (1)