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Trial record 1 of 1 for:    NCT02577198
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Computerized Decision Support System Linked to Electronic Health Records to Improve Patient Care in a General Hospital (CODES)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02577198
First Posted: October 16, 2015
Last Update Posted: January 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Milan
Information provided by (Responsible Party):
Istituto Ortopedico Galeazzi
  Purpose
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.

Condition Intervention
Physician's Role Other: Medilogy Decision Support System (MediDSS)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Implementing an Evidence-based Computerized Decision Support System Linked to Electronic Health Records to Improve Patient Care in a General Hospital

Resource links provided by NLM:


Further study details as provided by Istituto Ortopedico Galeazzi:

Primary Outcome Measures:
  • Resolution rates [ Time Frame: 12 months ]
    Rate at which the medical problems, which are detected by the MediDSS software and reported through the reminders, are resolved (resolution rates).


Secondary Outcome Measures:
  • in-hospital mortality [ Time Frame: 12 months ]
  • length of hospital stay [ Time Frame: 12 months ]

Enrollment: 6479
Actual Study Start Date: November 2015
Study Completion Date: January 2017
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02577198


Locations
Italy
Ospedale di Vimercate
Vimercate, Lombardia, Italy
Sponsors and Collaborators
Istituto Ortopedico Galeazzi
University of Milan
Investigators
Principal Investigator: Pasquale Lorenzo Moja, MD, PhD Unità di Epidemiologia Clinica, IRCCS Istituto Ortopedico Galeazzi, Milano
  More Information

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. Review.
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, González-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.

Responsible Party: Istituto Ortopedico Galeazzi
ClinicalTrials.gov Identifier: NCT02577198     History of Changes
Other Study ID Numbers: C41J11000110008
First Submitted: October 14, 2015
First Posted: October 16, 2015
Last Update Posted: January 30, 2017
Last Verified: October 2016


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