title: Effect evaluation of an interprofessional medication therapy management approach for multimorbid patients in primary care: a cluster-randomized controlled trial in community care (WestGem study protocol).
abstract: 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.
  
  
  METHODS
  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 cost-effectiveness ratio. The acceptance of the interprofessional Medication Therapy Management approach is assessed by qualitative methods.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Current controlled trials ISRCTN41595373 .
authors.affiliation: Department of Clinical Pharmacy, University of Bonn, An der Immenburg 4, 53121, Bonn, Germany. rose@elefantenapo.de.|Elefanten-Apotheke gegr 1575, Steinstr. 14, 48565, Steinfurt, Germany. rose@elefantenapo.de.
authors.forename: Olaf
authors.initials: O
authors.lastname: Rose
authors.affiliation: Centre of Health Care Management and Public Health, Schumpeter School of Business and Economics, University of Wuppertal, Wuppertal, Germany. Schaffert@wiwi.uni-wuppertal.de.
authors.forename: Corinna
authors.initials: C
authors.lastname: Schaffert
authors.affiliation: Centre of Health Care Management and Public Health, Schumpeter School of Business and Economics, University of Wuppertal, Wuppertal, Germany. CzarneckiK@wiwi.uni-wuppertal.de.
authors.forename: Kathrin
authors.initials: K
authors.lastname: Czarnecki
authors.affiliation: Muenster University of Applied Science, Robert-Koch-Str. 30, 48149, Muenster, Germany. h.mennemann@fh-muenster.de.
authors.forename: Hugo S
authors.initials: HS
authors.lastname: Mennemann
authors.affiliation: Department of Pharmacy, University of Muenster, Corrensstr. 48, 48149, Muenster, Germany. waltering@pharmd.de.
authors.forename: Isabel
authors.initials: I
authors.lastname: Waltering
authors.affiliation: Institute of Medical Statistics, Informatics and Epidemiology, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany. stefanie.hamacher@uni-koeln.de.
authors.forename: Stefanie
authors.initials: S
authors.lastname: Hamacher
authors.affiliation: Institute of Medical Statistics, Informatics and Epidemiology, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany. moritz.felsch@uni-koeln.de.
authors.forename: Moritz
authors.initials: M
authors.lastname: Felsch
authors.affiliation: Institute of Medical Statistics, Informatics and Epidemiology, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany. lena.herich@uni-koeln.de.
authors.forename: Lena
authors.initials: L
authors.lastname: Herich
authors.affiliation: Centre of Health Care Management and Public Health, Schumpeter School of Business and Economics, University of Wuppertal, Wuppertal, Germany. koeberlein@wiwi.uni-wuppertal.de.
authors.forename: Juliane
authors.initials: J
authors.lastname: Köberlein
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000553:Ambulatory Care / Q000458:organization & administration*; D002985:Clinical Protocols; D015897:Comorbidity; D003362:Cost-Benefit Analysis; D005260:Female; D005858:Germany; D006801:Humans; D007400:Interprofessional Relations; D008297:Male; D054539:Medication Therapy Management / Q000458:organization & administration*; D019338:Polypharmacy; D011320:Primary Health Care / Q000458:organization & administration*; D036301:Qualitative Research; D011788:Quality of Life