Clinical Decision Support System (CDSS), Medication Therapy Management, Palliative Care, Quality of Life, Terminal Care
Conditions
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.
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.
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 with a life expectancy of less than 3 months.
Sponsors
Rijnstate Hospital
Ikazia Hospital, Rotterdam
Noordwest Ziekenhuisgroep
Laurens Cadenza Zuid
Nijmegen University Academic Network Family Medicine
Gezondheidscentrum Krimpen
Prof.dr Carin (C.C.D.) van der Rijt
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
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
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients' quality of life | Two weeks after baseline assessment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients' quality of life | At day 7, 21, 28, and then every 28 days until death, with a maximum of 24 weeks, | 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 |
| 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 | 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) |
| 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 | Measured by patients' attending health care professional |
| 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 | Measured by patients' attending health care professional |
| Time spent on discussing the medication with the patient | From inclusion until death, with a maximum of 24 weeks | 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) |
| Health care costs | Retrospectively over full study period (From inclusion until death, with a maximum of 24 weeks) | Measured by using a medical file checklist. Items to be assessed include: medication prescriptions, hospital admissions and in-hospital care |
| Medication prescriptions (All medication used by the patient during te whole study period) | From inclusion until death, with a maximum of 24 weeks | Measured by using a medical file checklist in our data management system. Derived from patients' medical records and the pharmacist's information system |
| Patient survival | From inclusion until death, with a maximum of 24 weeks | Derived from patients' medical records and contact with the patient |
| Occurence of thrombo-embolic and bleeding events | From inclusion until death, with a maximum of 24 weeks | Measured and reported in the data management system by the time between inclusion and death |
Other
| Measure | Time frame | Description |
|---|---|---|
| Costs of the intervention | Retrospectively over full study period. Full study period is from inclusion until death, with a maximum of 24 weeks. | 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) |
Countries
Netherlands
Outcome results
None listed