AMUSE: Appropriate Medication USE in Dutch terminal care

In this study the effect of a clinical decision support system (CDSS-OPTIMED) was studied to support physicians in their decision-making about deprescribing of medication for patients in the last phase of life. This was a national, multicenter, step-wedge clustered randomized controlled trial. Adult patients with a life-expectancy of at least 2 weeks and at most 3 months were eligible. When patients were included in the control group, care was provided as usual. When patients were included in the intervention group, physicians got automated medication advices via the CDSS-OPTIMED system. Seven centers participated during 8 time blocks of 12-16 weeks For the primary endpoint, 79 patients were evaluable in the control group and 80 patients in the intervention group. For most of the secondary endpoints, 117 patients were evaluable in the control group and 109 patients in the intervention group. The datasets exist of: - Baseline characteristics of the patients (institute of inclusion, gender, age, diagnosis, living situation, level of education, WHO performance status, comorbidities) - Information on the center of inclusion, study block and control/intervention group - Medication used by patients (medication, start/stop date, dose, administration route) - Quality of life at baseline, day 7, 14, 21, 28 and then every 28 days until death (or as long as the patient was able to fill in the questionnaire), with a maximum of 48 weeks (measured with the EORTC-QLQ-C15-PAL, which was rescaled from 1-7 to 0-100) - Symptom scores on pain, problems with sleeping, dry mouth, swallowing problems, lack of appetite, defecation, nausea, shortness of breath, tiredness, anxiety, depression and overall feeling at baseline, day 7, 14, 21, 28 and then every 28 days until death (or as long as the patient was able to fill in the questionnaire), with a maximum of 48 weeks. - Blood pressure and/or blood glucose levels at baseline, day 7, 14, 21, 28 and then every 28 days until death (or as long as the patient was able to fill in the questionnaire), with a maximum of 48 weeks - Thrombo-embolic and bleeding events (date of event, potentially related to medication use, potentially related to discontinuation of medication) - Conversations about medication (date, duration) - Overall survival in the control and intervention group - Information for the cost-effectiveness analysis: medication costs, hospital admissions (start/end date), daycare treatments, emergency department visits, outpatient department visits, consults by phone, caregiver visits outside the hospital, use of (specialized) home care (start/end date and hours a day), diagnostic procedures, treatments, oncological treatments and the costs for conversations about medication with the physician. In addition, for patients included in the intervention group, the following costs were taken into account: the costs for the time that the physician spend on answering the medication advices, processing costs of CDSS-OPTIMED, and the costs related to the installation and maintenance of CDSS-OPTIMED.

Endpoints: Primary endpoint: Quality of life at 14 days Secondary endpoints: symptom scores, blood pressure and/or glucose levels in case the patient used antihypertensive and/or antidiabetics, thrombo-embolic and bleeding events, time spent on discussing medication with patients, health care costs, medication used until death and overall survival.

1. https://publications.europa.eu/resource/authority/data-theme/HEAL

1. http://id.loc.gov/vocabulary/iso639-1/en

1. http://data.europa.eu/eli/reg/2016/679/oj

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