title: Optimizing polypharmacy among elderly hospital patients with chronic diseases--study protocol of the cluster randomized controlled POLITE-RCT trial.
abstract: BACKGROUND
  Treatment of patients with multimorbidity is challenging. A rational reduction of long-term drugs can lead to decreased mortality, less acute hospital treatment, and a reduction of costs. Simplification of drug treatment schemes is also related to higher levels of patient satisfaction and adherence. The POLITE-RCT trial will test the effectiveness of an intervention aiming at reducing the number of prescribed long-term drugs among multimorbid and chronically ill patients. The intervention focuses on the interface between primary and secondary health care and includes a pharmacist-based, patient-centered medication review prior to the patient's discharge from hospital.
  
  
  METHODS
  The POLITE-RCT trial is a cluster randomized controlled trial. Two major secondary health care providers of Mecklenburg-Western Pomerania, Germany, take part in the study. Clusters are wards of both medical centers. All wards where patients with chronic diseases and multimorbidity are regularly treated will be included. Patients aged 65+ years who take five or more prescribed long-term drugs and who are likely to spend at least 5 days in the participating hospitals will be recruited and included consecutively. Cluster-randomization takes place after a six-month baseline data collection period. Patients of the control group receive care as usual. The independent two main primary outcomes are (1) health-related quality of life (EQ-5D) and (2) the difference in the number of prescribed long-term pharmaceutical agents between intervention and control group. The secondary outcomes are appropriateness of prescribed medication (PRISCUS list, Beers Criteria, MAI), patient satisfaction (TSQM), patient empowerment (PEF-FB-9), patient autonomy (IADL), falls, re-hospitalization, and death. The points of measurement are at admission to (T0) and discharge from hospital (T1) as well as 6 and 12 months after discharge from the hospital (T2 and T3). In 42 wards, 1,626 patients will be recruited.
  
  
  CONCLUSIONS
  In case of positive evaluation, the proposed study will provide evidence for a sustainable reduction of polypharmacy by enhancing patient-centeredness and patient autonomy.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN42003273.
authors.affiliation: Institute of General Practice, Rostock University Medical Center, Rostock, Germany. christin.loeffler@med.uni-rostock.de.
authors.forename: Christin
authors.initials: C
authors.lastname: Löffler
authors.affiliation: Institute of General Practice, Rostock University Medical Center, Rostock, Germany. eva.drewelow@med.uni-rostock.de.
authors.forename: Eva
authors.initials: E
authors.lastname: Drewelow
authors.affiliation: Hospital Pharmacy, Rostock University Medical Center, Rostock, Germany. susanne.paschka@med.uni-rostock.de.
authors.forename: Susanne D
authors.initials: SD
authors.lastname: Paschka
authors.affiliation: Hospital Pharmacy, Rostock University Medical Center, Rostock, Germany. martina.frankenstein@med.uni-rostock.de.
authors.forename: Martina
authors.initials: M
authors.lastname: Frankenstein
authors.affiliation: Institute of General Practice, Rostock University Medical Center, Rostock, Germany. julia.eger@med.uni-rostock.de.
authors.forename: Julia
authors.initials: J
authors.lastname: Eger
authors.affiliation: Institute of General Practice, Rostock University Medical Center, Rostock, Germany. lisa.jatsch@med.uni-rostock.de.
authors.forename: Lisa
authors.initials: L
authors.lastname: Jatsch
authors.affiliation: Department of Internal Medicine II, Rostock University Medical Center, Rostock, Germany. emil.reisinger@med.uni-rostock.de.
authors.forename: Emil C
authors.initials: EC
authors.lastname: Reisinger
authors.affiliation: Dietrich-Bonhoeffer Hospital, Neubrandenburg, Germany. HallauerJ@dbknb.de.
authors.forename: Johannes F
authors.initials: JF
authors.lastname: Hallauer
authors.affiliation: Institute of Pharmacology, Rostock University Medical Center, Rostock, Germany. bernd.drewelow@med.uni-rostock.de.
authors.forename: Bernd
authors.initials: B
authors.lastname: Drewelow
authors.affiliation: Hospital Pharmacy, Rostock University Medical Center, Rostock, Germany. karen.heidorn@med.uni-rostock.de.
authors.forename: Karen
authors.initials: K
authors.lastname: Heidorn
authors.affiliation: AOK Scientific Institute (WIdO), Berlin, Germany. helmut.schroeder@wido.bv.aok.de.
authors.forename: Helmut
authors.initials: H
authors.lastname: Schröder
authors.affiliation: Institute of General Practice, Rostock University Medical Center, Rostock, Germany. anja.wollny@med.uni-rostock.de.
authors.forename: Anja
authors.initials: A
authors.lastname: Wollny
authors.affiliation: Institute for Biostatistics and Informatics in Medicine and Ageing Research, Rostock University Medical Center, Rostock, Germany. guenther.kundt@uni-rostock.de.
authors.forename: Günther
authors.initials: G
authors.lastname: Kundt
authors.affiliation: Rostock University Medical Center, Rostock, Germany. christian.schmidt@med.uni-rostock.de.
authors.forename: Christian
authors.initials: C
authors.lastname: Schmidt
authors.affiliation: Institute of General Practice, Rostock University Medical Center, Rostock, Germany. altiner@med.uni-rostock.de.
authors.forename: Attila
authors.initials: A
authors.lastname: Altiner
mesh_terms: D000368:Aged; D002908:Chronic Disease / Q000188:drug therapy*; D016000:Cluster Analysis; D005858:Germany; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D008134:Long-Term Care; D017060:Patient Satisfaction; D019338:Polypharmacy; D055553:Prescription Drugs / Q000627:therapeutic use*
chemical_list: D055553:Prescription Drugs