Physician's RoleCODESNCT02577198
Computerized Decision Support System Linked to Electronic Health Records to Improve Patient Care in a General Hospital
A study testing Medilogy Decision Support System (MediDSS) in people with Physician's Role, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Physician's Role
- What is being tested?
- Medilogy Decision Support System (MediDSS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,479 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2015to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All of the patients admitted into the internal medicine departments of the Azienda Ospedaliera di Desio e Vimercate during the study period.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Physician's Role
- Being tested
- Medilogy Decision Support System (MediDSS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medilogy Decision Support System (MediDSS)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Electronic Health Records with computerised decision support system activated Medilogy Decision Support System (MediDSS) Receives: Other: Medilogy Decision Support System (MediDSS) |
| Control | Other | Electronic Health Records with computerised decision support system silenced Medilogy Decision Support System (MediDSS) silenced Receives: Other: Medilogy Decision Support System (MediDSS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution rates
Rate at which the medical problems, which are detected by the MediDSS software and reported through the reminders, are resolved (resolution rates).
Measured: 12 months
Secondary outcomes (2)
in-hospital mortality
Measured: 12 months
length of hospital stay
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Physician's RoleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6,479 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milan
- Responsible party
- Sponsor
- Investigators
- Pasquale Lorenzo Moja, MD, PhD, Principal investigator, Unità di Epidemiologia Clinica, IRCCS Istituto Ortopedico Galeazzi, Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02577198
- Sponsor's protocol ID
- C41J11000110008
- Acronym
- CODES
- Status last verified
- Oct 2016
- First submitted
- 14 Oct 2015
- Last updated
- 30 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 25322302Moja 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.
PubMed 25163794Liberati 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.
PubMed 25959891Moja 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.
PubMed 27389248Moja 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.
PubMed 31825499
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing an Evidence-based Computerized Decision Support System Linked to Electronic Health Records to Improve Patient Care in a General Hospital
- ClinicalTrials.gov ID
- NCT02577198
- Acronym / sponsor ID
- CODES / C41J11000110008
- Conditions
- Physician's Role
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,479 participants (actual)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Collaborators
- University of Milan
- Study start
- Nov 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 16 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Medilogy Decision Support System (MediDSS)Electronic Health Records with computerised decision support system activated Medilogy Decision Support System (MediDSS) |
| Control | Other | Other: Medilogy Decision Support System (MediDSS)Electronic Health Records with computerised decision support system silenced Medilogy Decision Support System (MediDSS) silenced |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All of the patients admitted into the internal medicine departments of the Azienda Ospedaliera di Desio e Vimercate during the study period.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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, Intervention |
Primary outcome
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).
2 secondary outcomes
in-hospital mortality
Time frame: 12 months
length of hospital stay
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
- Background: PubMed 25322302Moja 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.
- Background: PubMed 25163794Moja 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.
- Background: PubMed 25959891Liberati 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.
- Background: PubMed 27389248Moja 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.
- Derived from this study: PubMed 31825499Moja 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pasquale Lorenzo Moja, MD, PhD principal investigator
Unità di Epidemiologia Clinica, IRCCS Istituto Ortopedico Galeazzi, Milano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medilogy Decision Support System (MediDSS) in people with Physician's Role, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution rates (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02577198, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2017; AzTrials last refreshed its copy on 31 Oct 2026.