Implementing an evidence-based computerized decision support system linked to electronic health records to improve care for cancer patients: the ONCO-CODES study protocol for a randomized controlled trial

Lorenzo Moja, Alessandro Passardi, Matteo Capobussi, Rita Banzi, Francesca Ruggiero, Koren Kwag, Elisa Giulia Liberati, Massimo Mangia, Ilkka Kunnamo, Michela Cinquini, Roberto Vespignani, Americo Colamartini, Valentina Di Iorio, Ilaria Massa, Marien González-Lorenzo, Lorenzo Bertizzolo, Peter Nyberg, Jeremy Grimshaw, Stefanos Bonovas, Oriana Nanni, Lorenzo Moja, Alessandro Passardi, Matteo Capobussi, Rita Banzi, Francesca Ruggiero, Koren Kwag, Elisa Giulia Liberati, Massimo Mangia, Ilkka Kunnamo, Michela Cinquini, Roberto Vespignani, Americo Colamartini, Valentina Di Iorio, Ilaria Massa, Marien González-Lorenzo, Lorenzo Bertizzolo, Peter Nyberg, Jeremy Grimshaw, Stefanos Bonovas, Oriana Nanni

Abstract

Background: Computerized decision support systems (CDSSs) are computer programs that provide doctors with person-specific, actionable recommendations, or management options that are intelligently filtered or presented at appropriate times to enhance health care. CDSSs might be integrated with patient electronic health records (EHRs) and evidence-based knowledge.

Methods/design: The Computerized DEcision Support in ONCOlogy (ONCO-CODES) trial is a pragmatic, parallel group, randomized controlled study with 1:1 allocation ratio. The trial is designed to evaluate the effectiveness on clinical practice and quality of care of a multi-specialty collection of patient-specific reminders generated by a CDSS in the IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) hospital. We hypothesize that the intervention can increase clinician adherence to guidelines and, eventually, improve the quality of care offered to cancer patients. The primary outcome is the rate at which the issues reported by the reminders are resolved, aggregating specialty and primary care reminders. We will include all the patients admitted to hospital services. All analyses will follow the intention-to-treat principle.

Discussion: The results of our study will contribute to the current understanding of the effectiveness of CDSSs in cancer hospitals, thereby informing healthcare policy about the potential role of CDSS use. Furthermore, the study will inform whether CDSS may facilitate the integration of primary care in cancer settings, known to be usually limited. The increasing use of and familiarity with advanced technology among new generations of physicians may support integrated approaches to be tested in pragmatic studies determining the optimal interface between primary and oncology care.

Trial registration: ClinicalTrials.gov, NCT02645357.

Keywords: Computerized decision support systems; Electronic health records; Electronic patient records; Evidence-based medicine; Oncology; Pragmatic trial; Randomized controlled trial; Reminder systems.

Figures

Fig. 1
Fig. 1
Trial flow chart
Fig. 2
Fig. 2
Activation button
Fig. 3
Fig. 3
Reminder

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