title: Implementing an evidence-based computerized decision support system to improve patient care in a general hospital: the CODES study protocol for a randomized controlled trial.
abstract: Computerized decision support systems (CDSSs) are information technology-based software that provide health professionals with actionable, patient-specific recommendations or guidelines for disease diagnosis, treatment, and management at the point-of-care. These messages are intelligently filtered to enhance the health and clinical care of patients. CDSSs may be integrated with patient electronic health records (EHRs) and evidence-based knowledge.
  
  
  
  We designed a pragmatic randomized controlled trial to evaluate the effectiveness of patient-specific, evidence-based reminders generated at the point-of-care by a multi-specialty decision support system on clinical practice and the quality of care. We will include all the patients admitted to the internal medicine department of one large general hospital. The primary outcome is the rate at which medical problems, which are detected by the decision support software and reported through the reminders, are resolved (i.e., resolution rates). Secondary outcomes are resolution rates for reminders specific to venous thromboembolism (VTE) prevention, in-hospital all causes and VTE-related mortality, and the length of hospital stay during the study period.
  
  
  
  The adoption of CDSSs is likely to increase across healthcare systems due to growing concerns about the quality of medical care and discrepancy between real and ideal practice, continuous demands for a meaningful use of health information technology, and the increasing use of and familiarity with advanced technology among new generations of physicians. The results of our study will contribute to the current understanding of the effectiveness of CDSSs in primary care and hospital settings, thereby informing future research and healthcare policy questions related to the feasibility and value of CDSS use in healthcare systems. This trial is seconded by a specialty trial randomizing patients in an oncology setting (ONCO-CODES).
  
  
  
  ClinicalTrials.gov, https://clinicaltrials.gov/ct2/show/NCT02577198?term=NCT02577198&rank=1.
authors.affiliation: Department of Biomedical Sciences for Health, University of Milan, Via Pascal 36, 20133, Milan, Italy. lorenzo.moja@unimi.it.|Clinical Epidemiology Unit, IRCCS Orthopedic Institute Galeazzi, Via Galeazzi 4, 20161, Milan, Italy. lorenzo.moja@unimi.it.
authors.forename: Lorenzo
authors.identifier: 0000-0001-6680-6507
authors.initials: L
authors.lastname: Moja
authors.affiliation: Internal Medicine Division, Medical Department, Vimercate Hospital, Via Santi Cosma e Damiano 10, 20871, Vimercate, Italy.
authors.forename: Hernan
authors.initials: H
authors.lastname: Polo Friz
authors.affiliation: School of Specialization in Hygiene and Preventive Medicine, University of Milan, Milan, Italy.
authors.forename: Matteo
authors.initials: M
authors.lastname: Capobussi
authors.affiliation: Clinical Epidemiology Unit, IRCCS Orthopedic Institute Galeazzi, Via Galeazzi 4, 20161, Milan, Italy.
authors.forename: Koren
authors.initials: K
authors.lastname: Kwag
authors.affiliation: IRCCS Mario Negri Institute for Pharmacological Research, Via La Masa 19, 20156, Milan, Italy.
authors.forename: Rita
authors.initials: R
authors.lastname: Banzi
authors.affiliation: Clinical Epidemiology Unit, IRCCS Orthopedic Institute Galeazzi, Via Galeazzi 4, 20161, Milan, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Ruggiero
authors.affiliation: Department of Biomedical Sciences for Health, University of Milan, Via Pascal 36, 20133, Milan, Italy.
authors.forename: Marien
authors.initials: M
authors.lastname: González-Lorenzo
authors.affiliation: Department of Health Science, Centre for Medicine, University of Leicester, University Road, Leicester, LE1 7RH, UK.
authors.forename: Elisa Giulia
authors.initials: EG
authors.lastname: Liberati
authors.affiliation: Medilogy Srl, Viale Monza 133, 20125, Milan, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Mangia
authors.affiliation: Duodecim Medical Publications Ltd, Kaivokatu 10 A, 00101, Helsinki, Finland.
authors.forename: Peter
authors.initials: P
authors.lastname: Nyberg
authors.affiliation: Duodecim Medical Publications Ltd, Kaivokatu 10 A, 00101, Helsinki, Finland.
authors.forename: Ilkka
authors.initials: I
authors.lastname: Kunnamo
authors.affiliation: Internal Medicine Division, Medical Department, Vimercate Hospital, Via Santi Cosma e Damiano 10, 20871, Vimercate, Italy.
authors.forename: Claudio
authors.initials: C
authors.lastname: Cimminiello
authors.affiliation: Internal Medicine Division, Medical Department, Vimercate Hospital, Via Santi Cosma e Damiano 10, 20871, Vimercate, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Vighi
authors.affiliation: Ottawa Hospital Research Institute & Department of Medicine, University of Ottawa, 501 Smyth Road, Ottawa, ON, K1H 8L6, Canada.
authors.forename: Jeremy
authors.initials: J
authors.lastname: Grimshaw
authors.affiliation: Humanitas Clinical and Research Center, Via Manzoni 56, 20089, Rozzano, Milan, Italy.
authors.forename: Stefanos
authors.initials: S
authors.lastname: Bonovas
mesh_terms: D020000:Decision Support Systems, Clinical; D003695:Delivery of Health Care / Q000379:methods*; D019317:Evidence-Based Medicine / Q000379:methods*; D006769:Hospitals, General; D006801:Humans; D005791:Patient Care / Q000379:methods*; D011787:Quality of Health Care; D012107:Research Design
keywords: Computerized decision support systems; Electronic health records; Evidence-based medicine; Pragmatic trial; Randomized controlled trial; Reminder systems