چکیده (انگلیسی):

Background:Pharmaceutical practice worldwide is developing towards patient care. Medication Review (MR) and
Medication Therapy Management (MTM) are evolving as the most prominent services in pharmaceutical care and
have a strong potential to provide a large benefit for patients and society. MTMs can only be performed in an
interprofessional, collaborative setting. Several international studies have explored the effects of a MTM on the
quality of therapy and costs. For Germany the data is still deficient. This study aims to provide data on the effects
of an interprofessional MTM regarding quality of therapy, quality of life, costs and cost-effectiveness.
Method/Design:The study is designed as a cluster-randomized controlled trial in primary care, involving 12
outpatient clinics (clusters) and 165 patients. Primary care units are allocated to interventions using a Stepped
Wedge Design. All units are initially assigned to the control group. After a 6 month observation period, general
practitioners (GP) are randomly allocated to one of three groups and the interprofessional medication therapy
management approach is implemented sequentially per each group with a lag of 3 months between. The primary
outcome is the change in the quality of therapy measured by the MAI (Medication Appropriateness Index).
Secondary outcomes include changes in the number of drug related problems, medication complexity, changes
in drug-adherence, changes in health-status and function, quality of life, direct costs and the incremental costeffectiveness ratio. The acceptance of the interprofessional Medication Therapy Management approach is assessed
by qualitative methods.
Discussion:The patient interview and brown bag review are activities, typically provided by the pharmacist. In this
trial the patient is blinded to the pharmacist. The strength of having the patient blinded to the pharmacists is to
exclude skepticism of the patient toward unknown pharmacies, which might be a major confounder in a regional
and community setting. A weakness is that some patient related data might reach the pharmacists in a way, which
might differ from self-acquired data.
Trial registration:Current controlled trials ISRCTN41595373.