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

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.

Interprofessional Medication Management in Patients With Multiple Morbidities

“…The ethics committee at the Medical Association of Westphalia-Lippe (AKZ-2013-292-f-s) approved the study. The published study protocol provides a detailed description of the WestGem study (23).…”

“…Data were collected by using different documentation media (for a detailed description, see [23]). For the endpoints explained in the Results section, eTable 1 shows a summary of the fundamentals and instruments of documentation.…”

“…The required sample size to achieve a power of 1-β = 80%, a two-sided significance level of α = 5%, an effect size of Cohen's d=0. 25, and after defining all required variables (ICC=0.05; for more see [23]), was 240 patients.…”

Effect of training and structured medication review on medication appropriateness in nursing home residents and on cooperation between health care professionals: the InTherAKT study protocol

“…Other studies found no effects on number of drugs, costs or on medication appropriateness according to Medical Product Agency guidelines (which represents a country-specific Swedish list of drugs with possible effects of cognitive impairment that was used before the introduction of Beers criteria or generally applicable PIP lists) [7, 10]. However, combined interprofessional approaches consisting of educational training and structured medication review processes [8, 21, 22] seem to be most promising.…”

Effectiveness of the clinical pharmacist in reducing mortality in hospitalized cardiac patients: a propensity score-matched analysis

“…PS matching can obtain approximately the same study effects as a randomized controlled trial when used in the design of an epidemiological study and it will be better if a randomized controlled trial is to be carried out. 27 …”