Prioritising and Optimising Multiple Medications in Elderly Multimorbid Patients in General Practice. - A Pragmatic Cluster-randomised Controlled Trial.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Disease
- Sponsor
- Goethe University
- Enrollment
- 505
- Locations
- 1
- Primary Endpoint
- Medication Appropriateness Index (MAI)-Score
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
Objective: To investigate whether the complex intervention will improve the appropriateness of prescriptions in elderly multi-morbid patients with multi-medication in general practices.
Study hypothesis: The primary objective of the study is to determine whether the complex intervention will improve the appropriateness of prescriptions compared to usual care. The primary efficacy endpoint is the change in the Medication Appropriateness Index (MAI) score from baseline (T0) to 6 months after baseline (T1), i.e. the difference MAI T1-T0.
Detailed Description
Key elements (1 to 4) of the complex intervention: 1. Basic assessment of medicines that were actually taken (brown bag review) by a general practice based health care assistant (HCA) and 2. Checklist-based (MediMoL - Medication-Monitoring-List) pre-consultation interview on problems relating to medicines (technical handling, potential adverse drug reactions) and patient's therapeutic aims by HCA provides structured information in the Medication-Monitoring-List (MediMoL) for the general practitioner (GP) and enables patients to discuss their problems with the GP. 3. GP uses a computerized decision support system (pharmaceutical information system, AiD+) to optimize medication (reducing number of inappropriate prescriptions, e.g. pharmaceutical interactions, renal dose adjustments, duplicate prescriptions) and 4. prioritizes medication in the physician-patient consultation taking into consideration patient's preferences.
Investigators
Christiane Muth
Dr. Chrstiane Muth, MD, MPH
Goethe University
Eligibility Criteria
Inclusion Criteria
- •at least 60 years old of both sexes
- •at least three chronic diseases affecting two or more organ systems, which require pharmaceutical treatment
- •at least five long-term prescriptions with systemic effects
- •health care provided by GP (at least one contact in most recent quarter)
- •patient is legally competent to sign any documents
- •ability to understand and participate in trial of own free will, to fill out questionnaires and participate in telephone interviews
- •written informed consent to participate in trial
Exclusion Criteria
- •diseases cause life expectancy of less than 12 months
- •abuse of alcohol or illegal drugs and visible clinical signs or symptoms thereof
- •cognitive impairment that prevents trial participation (MMSE \< 26)
- •emotional stress that prevents trial participation
- •participation in a clinical trial within the last 30 days
Outcomes
Primary Outcomes
Medication Appropriateness Index (MAI)-Score
Time Frame: 6 months from baseline
Difference in Medication Appropriateness Index (MAI)-Score 6 months from baseline minus baseline (MAI T1-T0)
Secondary Outcomes
- medication complexity(6 and 9 months from baseline)
- Change in all cause hospitalisation(6 months and 9 months)
- Cognitive dysfunction in verbal fluency(6 and 9 months from baseline)
- Depressive symptoms(6 and 9 months from baseline)
- Functional disability: Vulnerable Elderly Survey (VES-13)(9 months)
- Self-reported adherence (Morisky)(6 and 9 months from baseline)
- Beliefs about Medicines Questionaire (BMQ)(6 and 9 months from baseline)
- Satisfaction with shared decision making (Man Son Hing scale, MSH)(6 and 9 months from baseline)
- Future life expectancy / years of desired life(6 and 9 months from baseline)
- MAI-Score(9 months from baseline)
- "Observed" adherence(6 months from baseline and 9 months from baseline)
- Severity of chronic pain(6 and 9 months from baseline)
- Generic health related quality of life: EQ-5D(9 months)