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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02577198
Other study ID # C41J11000110008
Secondary ID
Status Completed
Phase N/A
First received October 14, 2015
Last updated January 27, 2017
Start date November 2015
Est. completion date January 2017

Study information

Verified date October 2016
Source Istituto Ortopedico Galeazzi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 6479
Est. completion date January 2017
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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:

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Italy Ospedale di Vimercate Vimercate Lombardia

Sponsors (2)

Lead Sponsor Collaborator
Istituto Ortopedico Galeazzi University of Milan

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 in-hospital mortality 12 months
Secondary length of hospital stay 12 months
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