title: Comprehensive educational plan for patients with epilepsy and comorbidity (EDU-COM): a pragmatic randomised trial.
abstract: BACKGROUND
  The impact of educational strategies in the management of adverse treatment effects and drug interactions in adult patients with epilepsy with comorbidities remains undetermined.
  
  
  OBJECTIVE
  The EDU-COM study is a randomised, pragmatic trial investigating the effect of a patient-tailored educational plan in patients with epilepsy with comorbidity.
  
  
  METHODS
  174 adult patients with epilepsy with chronic comorbidities, multiple-drug therapy and reporting at least one adverse treatment effect and/or drug interaction at study entry were randomly assigned to the educational plan or usual care. The primary endpoint was the number of patients becoming free from adverse treatment events and/or drug interactions after a 6-month follow-up. The number of adverse treatment events and drug interactions, health-related quality of life (HRQOL) summary score changes and the monetary costs of medical contacts and drugs were assessed as secondary outcomes.
  
  
  RESULTS
  The primary endpoint was met by 44.0% of patients receiving the educational plan versus 28.9% of those on usual care (p=0.0399). The control group reported a significantly higher risk not to meet successfully the primary endpoint at the end of the study: OR (95% CI) of 2.29 (1.03 to 5.09). A separate analysis on drug adverse effects and drug interactions showed that the latter were more sensitive to the effect of educational treatment. Quality of life and costs were not significantly different in the two groups.
  
  
  CONCLUSIONS
  A patient-tailored educational strategy is effective in reducing drug-related problems (particularly drug interactions) in epilepsy patients with chronic comorbidities, without adding significant monetary costs. Registered at ClinicalTrials.gov, identifier NCT01804322, (http://www.clinicaltrials.gov).
authors.affiliation: Department of Neurology, San Gerardo Hospital, University of Milano Bicocca, Monza, Italy.
authors.forename: Simone
authors.identifier: http://orcid.org/0000-0002-9417-2748
authors.initials: S
authors.lastname: Beretta
authors.affiliation: IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Milano, Italy.
authors.forename: Ettore
authors.initials: E
authors.lastname: Beghi
authors.affiliation: IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Milano, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Messina
authors.affiliation: IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Milano, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Gerardi
authors.affiliation: Department of Neuroscience, Careggi Hospital, Firenze, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Pescini
authors.affiliation: Department of Neuroscience, Careggi Hospital, Firenze, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: La Licata
authors.affiliation: Department of Medical and Experimental Sciences, Ospedali Riuniti, University of Foggia, Foggia, Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Specchio
authors.affiliation: Department of Medical and Experimental Sciences, Ospedali Riuniti, University of Foggia, Foggia, Italy.
authors.forename: Mariangela
authors.initials: M
authors.lastname: Ferrara
authors.affiliation: Health Sciences Department, Epilepsy Center, San Paolo Hospital, University of Milano, Milano, Italy.
authors.forename: Maria Paola
authors.initials: MP
authors.lastname: Canevini
authors.affiliation: Health Sciences Department, Epilepsy Center, San Paolo Hospital, University of Milano, Milano, Italy.
authors.forename: Katherine
authors.initials: K
authors.lastname: Turner
authors.affiliation: Health Sciences Department, Epilepsy Center, San Paolo Hospital, University of Milano, Milano, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: La Briola
authors.affiliation: Neurophysiology Unit, Fondazione Carlo Besta Neurological Institute, Milano, Italy.
authors.forename: Silvana
authors.initials: S
authors.lastname: Franceschetti
authors.affiliation: Neurophysiology Unit, Fondazione Carlo Besta Neurological Institute, Milano, Italy.
authors.forename: Simona
authors.initials: S
authors.lastname: Binelli
authors.affiliation: Neurophysiology Unit, Fondazione Carlo Besta Neurological Institute, Milano, Italy.
authors.forename: Isabella
authors.initials: I
authors.lastname: Giglioli
authors.affiliation: Neurophysiology Unit, Fondazione Istituto C. Mondino, Pavia, Italy.
authors.forename: Carlo Andrea
authors.initials: CA
authors.lastname: Galimberti
authors.affiliation: Clinical Trial Center & Antiepileptic Drugs, Fondazione Istituto "C. Mondino", Pavia, Italy.
authors.forename: Cinzia
authors.initials: C
authors.lastname: Fattore
authors.affiliation: Department of Neurology, S. Maria Nuova Hospital, Firenze, Italy.
authors.forename: Gaetano
authors.initials: G
authors.lastname: Zaccara
authors.affiliation: Department of Neurology, S. Maria Nuova Hospital, Firenze, Italy.
authors.forename: Luciana
authors.initials: L
authors.lastname: Tramacere
authors.affiliation: Department of Neurology, Ospedale di Circolo, Melegnano, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Sasanelli
authors.affiliation: Department of Neurology, Ospedale di Circolo, Melegnano, Italy.
authors.forename: Marta
authors.initials: M
authors.lastname: Pirovano
authors.affiliation: Department of Neurology, San Gerardo Hospital, University of Milano Bicocca, Monza, Italy.
authors.forename: Carlo
authors.initials: C
authors.lastname: Ferrarese
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000927:Anticonvulsants / Q000009:adverse effects / Q000627:therapeutic use; D015982:Bias; D017281:Cost of Illness; D003627:Data Interpretation, Statistical; D004347:Drug Interactions; D023381:Endpoint Determination; D004827:Epilepsy / Q000150:complications* / Q000191:economics / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D010353:Patient Education as Topic / Q000379:methods*; D018802:Patient-Centered Care; D011788:Quality of Life; D018401:Sample Size; D016037:Single-Blind Method; D012959:Socioeconomic Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000927:Anticonvulsants
keywords: ANTICONVULSANTS; EPILEPSY; NEUROPHARMACOLOGY