patienten met een levensverwachting van 6 maanden of minder, ongeacht de aandoening Chronic disease with a life expectancy of 6 months or less
Conditions
Interventions
We will evaluate the effect of a personalized medication advice on adequate
medication management in patients in the last phase of life provided by an CDSS
(CDSS-OPTIMED). An CDSS is a software prog
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patient: 1. Patient is 18 years or over and provides informed consent to participate. 2. The patient is aware that recovering from his/her disease is unlikely, as assessed by the attending physician. 3. The patient agrees to participate in the iLIVE cohort study. 4. The attending physician would not be surprised if the patient were to die within 6 months (*Surprise question*). 5. If the physician is uncertain about the surprise question, the patient is eligible if presenting with at least one SPICT indicator. Relative: Relatives of included patients are asked to participate if they are: 1. 18 years or over and provide informed consent to participate; aware that it is unlikely that the patient will recover from his/her disease; 2. capable of filling in a questionnaire in the country*s main language or in English.
Exclusion criteria
Exclusion criteria: Patient: 1. 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). 2. 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. Relative: Relatives are not eligible if they are incapable of filling in a questionnaire in the country*s main language or in English. No more than one relative per patient will be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patients* quality of life four weeks after baseline assessment as measured by the EORTC QLQ-C15-PAL questionnaire, quality of life question. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: - Symptoms (ESAS, four weeks after baseline assessment); - Health-related quality of life (EORTC QLQ-C15-PAL quality of life question and EQ-5D, four weeks after baseline assessment); - Use of medication four weeks after baseline assessment (medical file data and pharmacist*s information system); - Use of medical interventions and costs of medical care (retrospective medical file data check about/of the last week of life); - Patient survival; - Satisfaction of the patient with medication (TSQM-9, four weeks after baseline assessment); - Satisfaction of the relative with medication (TSQM-9, adapted for relatives, four weeks after baseline assessment); - Satisfaction of the attending physician with the medicationadvices, generated by CDSS-OPTIMED (questionnaire, four weeks after baseline assessment); - Episodes of (retrospective medical file data, all between baseline assessment and death): o Symptomatic hypertension, o symptomatic hypotension, o symptomatic hypoglycaemia o symptomatic hyperglycaemia, o thrombo-embolic complications, o bleeding events Other study parameters - Health economic analysis and cost-effectiveness ratio of: o Patients and relatives at baseline and four weeks after baseline assessment (self-reported HRQoL, capabilities, resource use, employment and patient activities/informal care needs from patients based on the EQ-5D-5L, ICECAP-SCM or CPM, HEQ, partial IVICQ, CIIQ) o Intervention: development and training costs, operational costs (including time spent on discussing medication alerts with the pharmacist and patient/relative) For the subgroup of patients who will be included in the Netherlands extra endpoints will be measured: - Health economic analysis and cost-effectiveness ratio of patients every four weeks after baseline assessment (self-reported HRQoL, capabilities, resource use, employment and patient activities/informal care needs from patients based on the EQ-5D-5L, ICECAP-SCM, | — |
Countries
Netherlands
Outcome results
None listed