TY  - JOUR
A1  - Müller, Beate
A1  - Klaaßen-Mielke, Renate
A1  - González-González, Ana I.
A1  - Grandt, Daniel
A1  - Hammerschmidt, Reinhard
A1  - Köberlein-Neu, Juliane
A1  - Kellermann-Mühlhoff, Petra
A1  - Trampisch, Hans Joachim
A1  - Beckmann, Till
A1  - Düvel, Lara
A1  - Surmann, Bastian
A1  - Flaig, Benno
A1  - Ihle, Peter
A1  - Söling, Sara
A1  - Grandt, Simone
A1  - Dinh, Truc Sophia
A1  - Piotrowski, Alexandra
A1  - Meyer, Ingo
A1  - Karbach, Ute
A1  - Harder, Sebastian
A1  - Perera, Rafael
A1  - Glasziou, Paul
A1  - Pfaff, Holger
A1  - Greiner, Wolfgang
A1  - Gerlach, Ferdinand M.
A1  - Timmesfeld, Nina
A1  - Muth, Christiane
T1  - Effectiveness of the application of an electronic medication management support system in patients with polypharmacy in general practice: a study protocol of cluster-randomised controlled trial (AdAM)
T2  - BMJ open
N2  - Introduction: Clinically complex patients often require multiple medications. Polypharmacy is associated with inappropriate prescriptions, which may lead to negative outcomes. Few effective tools are available to help physicians optimise patient medication. This study assesses whether an electronic medication management support system (eMMa) reduces hospitalisation and mortality and improves prescription quality/safety in patients with polypharmacy. Methods and analysis: Planned design: pragmatic, parallel cluster-randomised controlled trial; general practices as randomisation unit; patients as analysis unit. As practice recruitment was poor, we included additional data to our primary endpoint analysis for practices and quarters from October 2017 to March 2021. Since randomisation was performed in waves, final study design corresponds to a stepped-wedge design with open cohort and step-length of one quarter. Scope: general practices, Westphalia-Lippe (Germany), caring for BARMER health fund-covered patients. Population: patients (≥18 years) with polypharmacy (≥5 prescriptions). Sample size: initially, 32 patients from each of 539 practices were required for each study arm (17 200 patients/arm), but only 688 practices were randomised after 2 years of recruitment. Design change ensures that 80% power is nonetheless achieved. Intervention: complex intervention eMMa. Follow-up: at least five quarters/cluster (practice). recruitment: practices recruited/randomised at different times; after follow-up, control group practices may access eMMa. Outcomes: primary endpoint is all-cause mortality and hospitalisation; secondary endpoints are number of potentially inappropriate medications, cause-specific hospitalisation preceded by high-risk prescribing and medication underuse. Statistical analysis: primary and secondary outcomes are measured quarterly at patient level. A generalised linear mixed-effect model and repeated patient measurements are used to consider patient clusters within practices. Time and intervention group are considered fixed factors; variation between practices and patients is fitted as random effects. Intention-to-treat principle is used to analyse primary and key secondary endpoints.
Y1  - 2021
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/64428
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-644281
SN  - 2044-6055
N1  - This study was funded by the Innovation Fund of the German Federal Joint Committee (grant no 01NVF16006).
VL  - 11
IS  - e048191
SP  - 1
EP  - 12
PB  - BMJ Publishing Group
CY  - London
ER  -