title: MEDUCATE trial: effectiveness of an intensive EDUCATional intervention for IT-mediated MEDication management in the outpatient clinic - study protocol for a cluster randomized controlled trial.
abstract: BACKGROUND
  Using information technology for medication management is an opportunity to help physicians to improve the quality of their documentation and communication and ultimately to improve patient care and patient safety. Physician education is necessary to take full advantage of information technology systems. In this trial, we seek to determine the effectiveness of an intensive educational intervention compared with the standard approach in improving information technology-mediated medication management and in reducing potential adverse drug events in the outpatient clinic.
  
  
  METHODS
  We are conducting a multicenter, cluster randomized controlled trial. The participants are specialists and residents working in the outpatient clinic of internal medicine, cardiology, pulmonology, geriatrics, gastroenterology and rheumatology. The intensive educational intervention is composed of a small-group session and e-learning. The primary outcome is discrepancies between registered medication (by physicians) and actually used medication (by patients). The key secondary outcomes are potential adverse events caused by missed drug-drug interactions. The primary and key secondary endpoints are being assessed shortly after the educational intervention is completed. Sample size will be calculated to ensure sufficient power. A sample size of 40 physicians per group and 20 patients per physician will ensure a power of >90 %, which means we will need a total of 80 physicians and 1,600 patients.
  
  
  CONCLUSIONS
  We performed an exploratory trial wherein we tested the recruitment process, e-learning, time schedule, and methods for data collection, data management and data analysis. Accordingly, we refined the processes and content: the recruitment strategy was intensified, extra measures were taken to facilitate smooth conductance of the e-learning and parts were made optional. First versions of the procedures for data collection were determined. Data entry and analysis was further standardized by using the G-standard database in the telephone questionnaire.
  
  
  BACKGROUND
  ISRCTN registry: ISRCTN50890124 . Registered 10 June 2013.
authors.affiliation: Department of Internal Medicine and Centre for Research and Development of Education, University Medical Centre Utrecht, the Netherlands, Hijmans van den Berghgebouw kamer 4.21, Huispostnummer HB 4.05, Postbus 85500, 3508, GA, Utrecht, The Netherlands. f.vanstiphout@umcutrecht.nl.
authors.forename: F
authors.initials: F
authors.lastname: van Stiphout
authors.affiliation: Department of Clinical Pharmacy, University Medical Centre Utrecht, Heidelberglaan 100, 3584, CX, Utrecht, The Netherlands. j.e.f.zwart-2@umcutrecht.nl.|Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Faculty of Science, Utrecht University, PO Box 80082, 3508, TB, Utrecht, The Netherlands. j.e.f.zwart-2@umcutrecht.nl.
authors.forename: J E F
authors.initials: JE
authors.lastname: Zwart-van Rijkom
authors.affiliation: Institute of Health Policy and Management, Erasmus University Rotterdam, Rotterdam, The Netherlands. jaarts@buffalo.edu.|Department of Biomedical Informatics, School of Medicine and Biomedical Sciences, University at Buffalo, Roosevelt Hall, 923 Main Street, Buffalo, NY, 14203, USA. jaarts@buffalo.edu.
authors.forename: J E C M
authors.initials: JE
authors.lastname: Aarts
authors.affiliation: Department of Health Technology Assessment, Julius Center, University Medical Centre Utrecht, Utrecht, The Netherlands. h.koffijberg@umcutrecht.nl.
authors.forename: H
authors.initials: H
authors.lastname: Koffijberg
authors.affiliation: Faculty of Medicine, Utrecht University, Universiteitsweg 98, 3584, CG, Utrecht, The Netherlands. e.n.dejonge@umcutrecht.nl.
authors.forename: E
authors.initials: E
authors.lastname: Klarenbeek-deJonge
authors.affiliation: Faculty of Medicine, Utrecht University, Universiteitsweg 98, 3584, CG, Utrecht, The Netherlands. merelkrulder@hotmail.com.
authors.forename: M
authors.initials: M
authors.lastname: Krulder
authors.affiliation: Department of Quality and Patient Safety, University Medical Centre Utrecht, Utrecht, The Netherlands. k.c.b.roes@umcutrecht.nl.
authors.forename: K C B
authors.initials: KC
authors.lastname: Roes
authors.affiliation: Department of Clinical Pharmacy, University Medical Centre Utrecht, Heidelberglaan 100, 3584, CX, Utrecht, The Netherlands. a.c.g.egberts@umcutrecht.nl.|Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Faculty of Science, Utrecht University, PO Box 80082, 3508, TB, Utrecht, The Netherlands. a.c.g.egberts@umcutrecht.nl.
authors.forename: A C G
authors.initials: AC
authors.lastname: Egberts
authors.affiliation: Department of Internal Medicine and Centre for Research and Development of Education, University Medical Centre Utrecht, the Netherlands, Hijmans van den Berghgebouw kamer 4.21, Huispostnummer HB 4.05, Postbus 85500, 3508, GA, Utrecht, The Netherlands. e.terbraak@umcutrecht.nl.
authors.forename: E W M T
authors.initials: EW
authors.lastname: ter Braak
mesh_terms: D000553:Ambulatory Care / Q000379:methods*; D000554:Ambulatory Care Facilities; D001291:Attitude of Health Personnel; D002983:Clinical Competence; D020000:Decision Support Systems, Clinical; D004347:Drug Interactions; D064420:Drug-Related Side Effects and Adverse Reactions / Q000517:prevention & control*; D004502:Education, Medical, Continuing / Q000379:methods*; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007318:Inservice Training / Q000379:methods*; D062527:Meaningful Use; D050316:Medical Order Entry Systems; D008508:Medication Errors / Q000517:prevention & control*; D054539:Medication Therapy Management / Q000193:education*; D009426:Netherlands; D012107:Research Design; D018401:Sample Size