Computerized Decision Support System Linked to Electronic Health Records to Improve Patient Care in a General Hospital (CODES)

Implementing an Evidence-based Computerized Decision Support System Linked to Electronic Health Records to Improve Patient Care in a General Hospital

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. CDSSs may be integrated with patient electronic health records (EHRs) and evidence-based knowledge.

Study Overview

• Status: Completed
• Conditions: Physician's Role
• Intervention / Treatment: Other: Medilogy Decision Support System (MediDSS)

Detailed Description

The investigators designed a pragmatic randomized controlled trial to evaluate the effectiveness of patient-specific, point-of-care reminders on clinical practice and the quality of care. The investigators hypothesize that these reminders can increase clinician adherence to guidelines and, eventually, improve the quality of care offered to hospitalized patients. The results of the investigators study will contribute to the current understanding of the effectiveness of CDSSs in primary care and hospital settings.

• Study Type: Interventional
• Enrollment (Actual): 6479
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Lombardia
    • Vimercate, Lombardia, Italy
      • Ospedale di Vimercate

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

All of the patients admitted into the internal medicine departments of the Azienda Ospedaliera di Desio e Vimercate during the study period.

Exclusion Criteria:

None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Electronic Health Records with computerised decision support system activated Medilogy Decision Support System (MediDSS)	Other: Medilogy Decision Support System (MediDSS); Italian translation of Evidence-Based Medicine electronic Decision Support (EBMeDS), a set of rules (scripts) based on Evidence Based Medicine guidelines and applied to structured health data. MediDSS further includes knowledge from Swedish, Finnish, INteraction X-referencing (SFINX), a drug-drug interaction database containing concise evidence-based information of about 18,000 drug interactions and adverse events. MediDSS is integrated with local reminders.
Other: Control; Electronic Health Records with computerised decision support system silenced Medilogy Decision Support System (MediDSS) silenced	Other: Medilogy Decision Support System (MediDSS); Italian translation of Evidence-Based Medicine electronic Decision Support (EBMeDS), a set of rules (scripts) based on Evidence Based Medicine guidelines and applied to structured health data. MediDSS further includes knowledge from Swedish, Finnish, INteraction X-referencing (SFINX), a drug-drug interaction database containing concise evidence-based information of about 18,000 drug interactions and adverse events. MediDSS is integrated with local reminders.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resolution rates	Rate at which the medical problems, which are detected by the MediDSS software and reported through the reminders, are resolved (resolution rates).	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
in-hospital mortality	12 months
length of hospital stay	12 months

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Galeazzi
• Collaborators: University of Milan
• Investigators: Principal Investigator: Pasquale Lorenzo Moja, MD, PhD, Unità di Epidemiologia Clinica, IRCCS Istituto Ortopedico Galeazzi, Milano

Publications and helpful links

General Publications

• Moja L, Kwag KH, Lytras T, Bertizzolo L, Brandt L, Pecoraro V, Rigon G, Vaona A, Ruggiero F, Mangia M, Iorio A, Kunnamo I, Bonovas S. Effectiveness of computerized decision support systems linked to electronic health records: a systematic review and meta-analysis. Am J Public Health. 2014 Dec;104(12):e12-22. doi: 10.2105/AJPH.2014.302164. Epub 2014 Oct 16.
• Moja L, Liberati EG, Galuppo L, Gorli M, Maraldi M, Nanni O, Rigon G, Ruggieri P, Ruggiero F, Scaratti G, Vaona A, Kwag KH. Barriers and facilitators to the uptake of computerized clinical decision support systems in specialty hospitals: protocol for a qualitative cross-sectional study. Implement Sci. 2014 Aug 28;9:105. doi: 10.1186/s13012-014-0105-0.
• Liberati EG, Galuppo L, Gorli M, Maraldi M, Ruggiero F, Capobussi M, Banzi R, Kwag K, Scaratti G, Nanni O, Ruggieri P, Polo Friz H, Cimminiello C, Bosio M, Mangia M, Moja L. [Barriers and facilitators to the implementation of computerized decision support systems in Italian hospitals: a grounded theory study]. Recenti Prog Med. 2015 Apr;106(4):180-91. doi: 10.1701/1830.20032. Italian.
• Moja L, Polo Friz H, Capobussi M, Kwag K, Banzi R, Ruggiero F, Gonzalez-Lorenzo M, Liberati EG, Mangia M, Nyberg P, Kunnamo I, Cimminiello C, Vighi G, Grimshaw J, Bonovas S. 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. Implement Sci. 2016 Jul 7;11(1):89. doi: 10.1186/s13012-016-0455-x.
• Moja L, Polo Friz H, Capobussi M, Kwag K, Banzi R, Ruggiero F, Gonzalez-Lorenzo M, Liberati EG, Mangia M, Nyberg P, Kunnamo I, Cimminiello C, Vighi G, Grimshaw JM, Delgrossi G, Bonovas S. Effectiveness of a Hospital-Based Computerized Decision Support System on Clinician Recommendations and Patient Outcomes: A Randomized Clinical Trial. JAMA Netw Open. 2019 Dec 2;2(12):e1917094. doi: 10.1001/jamanetworkopen.2019.17094.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: October 14, 2015
• First Submitted That Met QC Criteria: October 15, 2015
• First Posted (Estimate): October 16, 2015

Study Record Updates

• Last Update Posted (Estimate): January 30, 2017
• Last Update Submitted That Met QC Criteria: January 27, 2017
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: C41J11000110008