Comprehensive educational plan for patients with epilepsy and comorbidity (EDU-COM): a pragmatic randomised trial.

Simone Beretta, Ettore Beghi, Paolo Messina, Francesca Gerardi, Francesca Pescini, Andrea La Licata, Luigi Specchio, Mariangela Ferrara, Maria Paola Canevini, Katherine Turner, Francesca La Briola, Silvana Franceschetti, Simona Binelli, Isabella Giglioli, Carlo Andrea Galimberti, Cinzia Fattore, Gaetano Zaccara, Luciana Tramacere, Francesco Sasanelli, Marta PirovanoCarlo Ferrarese

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Abstract

The impact of educational strategies in the management of adverse treatment effects and drug interactions in adult patients with epilepsy with comorbidities remains undetermined. The EDU-COM study is a randomised, pragmatic trial investigating the effect of a patient-tailored educational plan in patients with epilepsy with comorbidity. 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. 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. 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). Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Original languageEnglish
Pages (from-to)889-894
Number of pages6
JournalJournal of Neurology, Neurosurgery and Psychiatry
Volume85
Issue number8
Publication statusPublished - 2014

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ASJC Scopus subject areas

  • Medicine(all)

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Beretta, S., Beghi, E., Messina, P., Gerardi, F., Pescini, F., La Licata, A., Specchio, L., Ferrara, M., Canevini, M. P., Turner, K., La Briola, F., Franceschetti, S., Binelli, S., Giglioli, I., Galimberti, C. A., Fattore, C., Zaccara, G., Tramacere, L., Sasanelli, F., ... Ferrarese, C. (2014). Comprehensive educational plan for patients with epilepsy and comorbidity (EDU-COM): a pragmatic randomised trial. Journal of Neurology, Neurosurgery and Psychiatry, 85(8), 889-894.