NCT02577198

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,479

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 16, 2015

Completed
16 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

January 30, 2017

Status Verified

October 1, 2016

Enrollment Period

1.1 years

First QC Date

October 14, 2015

Last Update Submit

January 27, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • in-hospital mortality

    12 months

  • length of hospital stay

    12 months

Study Arms (2)

Intervention

EXPERIMENTAL

Electronic Health Records with computerised decision support system activated Medilogy Decision Support System (MediDSS)

Other: Medilogy Decision Support System (MediDSS)

Control

OTHER

Electronic Health Records with computerised decision support system silenced Medilogy Decision Support System (MediDSS) silenced

Other: Medilogy Decision Support System (MediDSS)

Interventions

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.

ControlIntervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale di Vimercate

Vimercate, Lombardy, Italy

Location

Related Publications (5)

  • 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.

    PMID: 25322302BACKGROUND
  • 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.

    PMID: 25163794BACKGROUND
  • 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.

    PMID: 25959891BACKGROUND
  • 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.

    PMID: 27389248BACKGROUND
  • 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 Officials

  • Pasquale Lorenzo Moja, MD, PhD

    Unità di Epidemiologia Clinica, IRCCS Istituto Ortopedico Galeazzi, Milano

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2015

First Posted

October 16, 2015

Study Start

November 1, 2015

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

January 30, 2017

Record last verified: 2016-10

Locations