Palliative Care
Conditions
Keywords
Palliative care, Medication Therapy Management, Clinical Decision Support System (CDSS), Communication
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
Detailed description
Rationale: Patients in the last phase of life often use many medications 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. Objective: the primary objective is to examine whether the use of a clinical decision support system (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 outcome is an assessment of the quality of life of patients, four weeks after baseline assessment Potential risks and benefits associated with participation: the intervention in the medication study supports physicians in using available evidence and knowledge when prescribing or 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 study 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.
Interventions
DEVICECDSS-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.
Sponsors
Lund University
Landspitali University Hospital
Medical University of Vienna
Prof. dr. Stefan Sleijfer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Before-after study design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
for patients: 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 would 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. 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. Inclusion criteria for relative/informal caregiver of included patients: 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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients' quality of life | 4 weeks after baseline assessment | measured by the EORTC QLQ-C15-PAL QoL question |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Use of medication of the patient | 4 weeks after baseline assessment | measured by the medical file data and pharmacist's information system |
| 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 | measured by the time between inclusion until death |
| Satisfaction of the patient and relative with medication | 4 weeks after baseline assessment | measured by the TSQM-9 |
| Patients' symptoms | 4 weeks after baseline assessment | measured by the ESAS |
| Episodes of symptomatic hypertension/hypotension/hyperglycaemia/hypoglycaemia and thrombo-embolic complications or bleeding events of the patient | 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 | collected via medical file data, using a pre-structured checklist |
| Socio-demographic characteristics of the patient | Baseline | Age, gender, current living situation, education, nationality, religion, socioeconomic status |
| Satisfaction of the attending physician with the CDSS-OPTIMED | 4 weeks after baseline assessment | measured by a self-developed questionnaire |
Other
| Measure | Time frame | Description |
|---|---|---|
| Relatives' capabilities | 4 weeks after baseline assessment | measured by the ICECAP-CPM |
| Relatives' informal care provision | 4 weeks after baseline assessment | measured by the partial IVICQ and CIIQ |
| Development and training costs of the intervention | Retrospectively over full study period, i.e. a period of 2 years | Based on proformas completed by the developers and the study personnel |
| Dutch patients' capabilities | 8 weeks after baseline assessment, repeated 4-weekly to a maximum of 24 weeks | measured by the ICECAP-SCM |
| Dutch patients' resource use, employment and patient activities/informal care needs | 8 weeks after baseline assessment, repeated 4-weekly to a maximum of 24 weeks | measured by the HEQ |
| Dutch subgroup patients' health related quality of life | 8 weeks after baseline assessment, repeated 4-weekly to a maximum of 24 weeks | measured by the EQ-5D-5L |
| Operational costs of the intervention | Retrospectively over full study period, i.e. a period of 2 years | Based on time spent on discussing medication alerts with the pharmacist and patient/relative and time registrations via automated system extracts |
| 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 | Measured by using a pre-structured checklist. Items to be assessed include: place of care, medical events and complications, medication use, medical and surgical interventions, goals of care statements, resuscitation policy, non-treatment decisions |
| Costs of medical care | 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 | Measured by using a pre-structured checklist. Items to be assessed include: place of care, medical events and complications, medication use, medical and surgical interventions, goals of care statements, resuscitation policy, non-treatment decisions |
| Patients' health related quality of life | 4 weeks after baseline assessment | measured by the EQ-5D-5L |
| Patients' capabilities | 4 weeks after baseline assessment | measured by the ICECAP-SCM |
| Patients' resource use, employment and patient activities/informal care needs | 4 weeks after baseline assessment | measured by the HEQ |
| Relatives' health related quality of life | 4 weeks after baseline assessment | measured by the EQ-5D-5L |
Countries
Netherlands, Sweden, Switzerland
Contacts
Primary ContactEline Elsten, MD
Backup ContactEric Geijteman, PhD
Outcome results
None listed