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)

BMC Family Practice

Study Protocol

Kathrin Czarnecki¹  Juliane Köberlein¹  Corinna Schaffert¹  Olaf Rose²  Isabel Waltering³  Stefanie Hamacher⁴  Moritz Felsch⁴  Lena Herich⁴  Hugo S. Mennemann⁵ 

[1] Centre of Health Care Management and Public Health, Schumpeter School of Business and Economics, University of Wuppertal, Wuppertal, Germany;Department of Clinical Pharmacy, University of Bonn, An der Immenburg 4, 53121, Bonn, Germany;Elefanten-Apotheke gegr 1575, Steinstr. 14, 48565, Steinfurt, Germany;Department of Pharmacy, University of Muenster, Corrensstr. 48, 48149, Muenster, Germany;Institute of Medical Statistics, Informatics and Epidemiology, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany;Muenster University of Applied Science, Robert-Koch-Str. 30, 48149, Muenster, Germany;

关键词: Polypharmacy;    Interprofessional;    Medication therapy management;    Medication review;    Multimorbidity;    Complex intervention;    Primary care;   

DOI  :  10.1186/s12875-015-0305-y

 received in 2015-06-12, accepted in 2015-07-08,  发布年份 2015

来源: Springer

【 摘 要 】

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.

【 授权许可】

Unknown   
© Rose et al. 2015. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.