Multi-medication in elderly multi-morbid patients Not Applicable
Conditions
Interventions
The trial has two arms: one intervention arm and one control arm.
The intervention consists of several components:
1. Medication reconciliation (brown-bag review)
Sponsors
German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients: 1. At least 65 years old, either sex 2. At least three chronic diseases 3. At least five continuous prescriptions 4. At least one practice visit during the last quarter 5. Written informed consent 6. Ability to fill out a questionnaire and participate in a telephone interview Practices: 1. Practice serves members of the German statutory health insurance system 2. GP practice 3. Physician is specialised in general practice or internal medicine, or without specialisation 4. Internet access 5. Availability of a practice nurse who can participate in the study
Exclusion criteria
Exclusion criteria: Patients: 1. Life expectancy of less than six months 2. Drug addiction problems 3. Cognitive impairment (Mini Mental State Examination [MMSE] score less than 26) 4. Emotional stress that would prevent participation in the study 5. Participation in a clinical trial within the last 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To evaluate practicability: expenditure of time regarding intervention 2. To evaluate feasibility: number of patients who dropped out, reasons for why patients do not participate in study, time expenditure regarding data collection 3. Potential primary outcome for main study: appropriateness of medication (Medication Appropriateness Index [MAI]) There are three timepoints of data collection in both, the control and the intervention arm: T0: before the beginning of the intervention T1: six weeks after the beginning of the intervention T2: twelve weeks after the beginning of the intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Complexity of medication (number of drugs, number of daily doses, Medication Regimen Complexity Index [MRCI]) 2. Observed adherence (drug score, dose score, regimen score) 3. Reported adherence (Medication Adherence Report Scale [MARS] and adherence according to Morisky) 4. Patient attitude toward medication (Beliefs about Medicines Questionnaire [BMQ]) 5. Patient satisfaction regarding information about medication 6. Health related quality of life (EQ-5D) 7. Functional disability (World Health Organization Disability Assessment Schedule II [WHO-DASII]) 8. Pain (Verbal Rating Scale) 9. Hospital days 10. Number of medication side effects There are three timepoints of data collection in both, the control and the intervention arm: T0: before the beginning of the intervention T1: six weeks after the beginning of the intervention T2: twelve weeks after the beginning of the intervention | — |
Countries
Germany
Outcome results
None listed