title: Impact of a tailored program on the implementation of evidence-based recommendations for multimorbid patients with polypharmacy in primary care practices-results of a cluster-randomized controlled trial.
abstract: Multimorbid patients receiving polypharmacy represent a growing population at high risk for negative health outcomes. Tailoring is an approach of systematic intervention development taking account of previously identified determinants of practice. The aim of this study was to assess the effect of a tailored program to improve the implementation of three important processes of care for this patient group: (a) structured medication counseling including brown bag reviews, (b) the use of medication lists, and (c) structured medication reviews to reduce potentially inappropriate medication.
  
  
  
  We conducted a cluster-randomized controlled trial with a follow-up time of 9 months. Participants were general practitioners (GPs) organized in quality circles and participating in a GP-centered care contract of a German health insurance. Patients aged >50 years, suffering from at least 3 chronic diseases, receiving more than 4 drugs, and being at high risk for medication-related events according to the assessment of the treating GP were enrolled. The tailored program consisted of a workshop for GPs and health care assistants, educational materials and reminders for patients, and the elaboration of implementation action plans. The primary outcome was the change in the degree of implementation between baseline and follow-up, measured by a summary score of 10 indicators. The indicators were based on structured surveys with patients and GPs.
  
  
  
  We analyzed the data of 21 GPs (10 - intervention group, 11 - control group) and 273 patients (130 - intervention group, 143 - control group). The increase in the degree of implementation was 4.2 percentage points (95% confidence interval: -0.3, 8.6) higher in the intervention group compared to the control group (p = 0.1). Two of the 10 indicators were significantly improved in the intervention group: medication counseling (p = 0.017) and brown bag review (p = 0.012). Secondary outcomes showed an effect on patients' self-reported use of medication lists when buying drugs in the pharmacy (p = 0.03).
  
  
  
  The tailored program may improve implementation of medication counseling and brown bag review whereas the use of medication lists and medication reviews did not improve. No effect of the tailored program on the combined primary outcome could be substantiated. Due to limitations of the study, results have to be interpreted carefully. The factors facilitating and hindering successful implementation will be examined in a comprehensive process evaluation.
  
  
  
  ISRCTN34664024 , assigned 14/08/2013.
authors.affiliation: Department of General Practice and Health Services Research, University Hospital Heidelberg, Im Neuenheimer Feld 130.3, Turm West, 4.OG, 69120, Heidelberg, Germany. cornelia.jaeger@med.uni-heidelberg.de.
authors.forename: Cornelia
authors.initials: C
authors.lastname: Jäger
authors.affiliation: Department of General Practice and Health Services Research, University Hospital Heidelberg, Im Neuenheimer Feld 130.3, Turm West, 4.OG, 69120, Heidelberg, Germany.
authors.forename: Tobias
authors.initials: T
authors.lastname: Freund
authors.affiliation: Institute of Family Medicine, UniversityHospital Schleswig-Holstein, Campus Lübeck, Ratzburger Allee 160, Haus 50, 23538, Lübeck, Germany.
authors.forename: Jost
authors.initials: J
authors.lastname: Steinhäuser
authors.affiliation: Department of Medical Biometry, Institute of Medical Biometry and Informatics, University Hospital Heidelberg, Im Neuenheimer Feld 130.3, Turm West, 12.OG, 69120, Heidelberg, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Stock
authors.affiliation: Department of Medical Biometry, Institute of Medical Biometry and Informatics, University Hospital Heidelberg, Im Neuenheimer Feld 130.3, Turm West, 12.OG, 69120, Heidelberg, Germany.
authors.forename: Johannes
authors.initials: J
authors.lastname: Krisam
authors.affiliation: Institute for Applied Quality Improvement and Research in Health Care GmbH, (AQUA-Institute), Maschmühlenweg 8-10, 37073, Göttingen, Germany.
authors.forename: Petra
authors.initials: P
authors.lastname: Kaufmann-Kolle
authors.affiliation: Department of General Practice and Health Services Research, University Hospital Heidelberg, Im Neuenheimer Feld 130.3, Turm West, 4.OG, 69120, Heidelberg, Germany.
authors.forename: Michel
authors.initials: M
authors.lastname: Wensing
authors.affiliation: Department of General Practice and Health Services Research, University Hospital Heidelberg, Im Neuenheimer Feld 130.3, Turm West, 4.OG, 69120, Heidelberg, Germany.
authors.forename: Joachim
authors.initials: J
authors.lastname: Szecsenyi
mesh_terms: D000328:Adult; D000368:Aged; D002908:Chronic Disease / Q000188:drug therapy*; D016000:Cluster Analysis; D003376:Counseling; D019317:Evidence-Based Medicine / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D058005:General Practitioners; D005858:Germany; D006284:Health Plan Implementation / Q000379:methods; D006801:Humans; D057970:Inappropriate Prescribing / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D019338:Polypharmacy; D011320:Primary Health Care / Q000379:methods*; D015397:Program Evaluation / Q000379:methods*
keywords: Communication; Medication list; Medication review; Multimorbidity; Polypharmacy; Potentially inappropriate medication; Randomized controlled trial; Tailoring