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)

Olaf Rose,Moritz Felsch,Isabel Waltering,Kathrin Czarnecki,Lena Herich,Stefanie Hamacher,Corinna Schaffert,Hugo S Mennemann,Juliane Köberlein

doi:10.1186/s12875-015-0305-y

Abstract

BackgroundPharmaceutical 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/DesignThe 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.DiscussionThe 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 registrationCurrent controlled trials ISRCTN41595373.

Highlights

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
The interprofessional approach combines case management routines of the home-care specialists at the patient-site with information gained during the advanced Medication Review by specialised and clinical experienced study pharmacists

Summary

Introduction

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. This study aims to provide data on the effects of an interprofessional MTM regarding quality of therapy, quality of life, costs and cost-effectiveness. Current interventions and MTM approaches Pharmaceutical practice worldwide is currently developing towards patient care. Like enhanced patient education have been well described and studied: Jalal et al found patient education, provided by pharmacists beneficial in cardiovascular diseases [8], Schmiedel et al recently found that patient education can reduce the risk to acquire diabetes [9]. Several studies could support the efficacy of patient counseling on drug-adherence [10] or patient skills in handling drug-devices [11,12,13]

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