Medical OncologyONCO-CODESNCT02645357
Implementing an Evidence-based Computerized Decision Support System Linked to Electronic Health Records to Improve Care for Cancer Patients
A study testing computer reminders on clinical practice in people with Medical Oncology, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 1 site in Italy.
Trial summary
Implementing an evidence-based computerized decision support system linked to electronic health records to improve care for cancer patients. The ONCO-CODES (Computerized DEcision Support in ONCOlogy) trial is a pragmatic, parallel group, randomized controlled study with 1:1 allocation ratio Study Duration 12 month… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medical Oncology
- What is being tested?
- computer reminders on clinical practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15,431 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The Investigators will include all the EHRs of patients admitted to the facilities of the IRST IRCCS.
Who cannot join
- There are no exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect on Professional Practice and Health Care Outcomes of Computerized Evidence-based Information System and Clinical Decision Support: A Randomized Controlled Trial in Orthopaedics (GR-2009-1606736)
Implementing an evidence-based computerized decision support system linked to electronic health records to improve care for cancer patients.
The ONCO-CODES (Computerized DEcision Support in ONCOlogy) trial is a pragmatic, parallel group, randomized controlled study with 1:1 allocation ratio Study Duration 12 month Study Center(s) Single-center
Objectives:
The primary outcome of this trial is a process outcome. i.e. the rate at which the issues reported by the reminders are resolved (resolution rates).
Read the detailed description
Implementing an evidence-based computerized decision support system linked to electronic health records to improve care for cancer patients.
Short Title/Acronym ONCO-CODES Protocol Code IRST100.23
Rationale:
Computerized decision support systems (CDSSs) are computer programs that provide clinicians, staff, patients, or other individuals with person-specific, actionable recommendations or management options that are intelligently filtered or presented at appropriate times to enhance health and health care. CDSSs might be integrated with patient electronic health records (EHRs) and evidence-based knowledge. The Investigators designed a pragmatic randomized controlled trial to evaluate the effectiveness of patient-specific, point-of-care reminders generated by the Medilogy Decision Support System (MediDSS) on clinical practice and the quality of care in the Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS. The Investigators hypothesize that MediDSS reminders can increase clinician adherence to guidelines and, eventually, improve the quality of care offered to hospitalized patient. The adoption of CDSSs is likely to increase across healthcare systems due to growing concerns about the quality of medical care and discrepancy between real and ideal practice, continuous calls for a meaningful use of health information technology, and the increasing use of and familiarity with advanced technology among new generations of physicians.
Study Design:
The ONCO-CODES (Computerized DEcision Support in ONCOlogy) trial is a pragmatic, parallel group, randomized controlled study with 1:1 allocation ratio Study Duration 12 month Study Center(s) Single-center
Objectives:
The primary outcome of this trial is a process outcome. i.e. the rate at which the issues reported by the reminders are resolved (resolution rates).
Number of Subjects:
The investigators calculated the sample size on the basis of the primary outcome. A sample of 1,704 reminders will be necessary to detect the difference between the two groups (power = 0.90; α =0.05, two-sided; 1:1 allocation). Since estimates for intracluster correlation are not available, Implementing an evidence-based computerized decision support system linked to electronic health records to improve care for cancer patients.
Diagnosis and Main Inclusion Criteria:
The investigators will include all the patients admitted to the facilities of the IRST IRCCS. There are no exclusion criteria
Statistical Methodology:
All analyses will follow the intention-to-treat principle: patients will be analyzed in the group to which they have been randomized. Descriptive statistics will be presented.
All statistical tests will be two-sided. The investigators will use the Stata software to perform all statistical analyses (Stata Corp., College Station, TX, USA).The investigators increased the required sample size (by 20%) to 2,046 reminders to account for clustering by patient.
- Conditions
- Medical Oncology
- Being tested
- computer reminders on clinical practice, Control group
- Keywords
- Oncology Patients, evidence-based, computerized, decision, support system, linked, electronic health records
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computer reminders on clinical practiceOther
on-screen, point-of-care computer reminders on clinical practice.
Control groupOther
control group
| Study group | Role | What they receive |
|---|---|---|
| computer reminders on clinical practice | Experimental | on-screen, point-of-care computer reminders on clinical practice. Receives: Other: computer reminders on clinical practice |
| Control group | Other | No on-screen, point-of-care computer reminders on clinical practice. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
resolution rates
the rate at which the issues reported by the reminders are resolved
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 posted1 Jan 2016 (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 (1)Papers the sponsor has linked to this study.
- Other trials for Medical OncologyStudies 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
- None (open label)
- Enrolment
- 15,431 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Italy, University of Milan, I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio, Catholic University of the Sacred Heart, Duodecim, Finnish Medical Association, Helsinki, Mario Negri Institute for Pharmacological Research, Ottawa Hospital Research Institute
- Responsible party
- Sponsor
- Investigators
- Alessandro Passardi, MD, Principal investigator, IRST IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02645357
- Sponsor's protocol ID
- IRST100.23
- Acronym
- ONCO-CODES
- Status last verified
- Feb 2017
- First submitted
- 31 Dec 2015
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Moja L, Passardi A, Capobussi M, Banzi R, Ruggiero F, Kwag K, Liberati EG, Mangia M, Kunnamo I, Cinquini M, Vespignani R, Colamartini A, Di Iorio V, Massa I, Gonzalez-Lorenzo M, Bertizzolo L, Nyberg P, Grimshaw J, Bonovas S, Nanni O. Implementing an evidence-based computerized decision support system linked to electronic health records to improve care for cancer patients: the ONCO-CODES study protocol for a randomized controlled trial. Implement Sci. 2016 Nov 25;11(1):153. doi: 10.1186/s13012-016-0514-3.
PubMed 27884165
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect on Professional Practice and Health Care Outcomes of Computerized Evidence-based Information System and Clinical Decision Support: A Randomized Controlled Trial in Orthopaedics (GR-2009-1606736)
- ClinicalTrials.gov ID
- NCT02645357
- Acronym / sponsor ID
- ONCO-CODES / IRST100.23
- Conditions
- Medical Oncology
- Keywords
- Oncology Patients, evidence-based, computerized, decision, support system, linked, electronic health records
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15,431 participants (actual)
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSUniversity, hospital or other
- Collaborators
- Ministry of Health, Italy, University of Milan, I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio, Catholic University of the Sacred Heart, Duodecim, Finnish Medical Association, Helsinki, Mario Negri Institute for Pharmacological Research, Ottawa Hospital Research Institute
- Study start
- Nov 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 1 Jan 2016 (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.
Implementing an evidence-based computerized decision support system linked to electronic health records to improve care for cancer patients.
The ONCO-CODES (Computerized DEcision Support in ONCOlogy) trial is a pragmatic, parallel group, randomized controlled study with 1:1 allocation ratio Study Duration 12 month Study Center(s) Single-center
Objectives:
The primary outcome of this trial is a process outcome. i.e. the rate at which the issues reported by the reminders are resolved (resolution rates).
Detailed description
Implementing an evidence-based computerized decision support system linked to electronic health records to improve care for cancer patients.
Short Title/Acronym ONCO-CODES Protocol Code IRST100.23
Rationale:
Computerized decision support systems (CDSSs) are computer programs that provide clinicians, staff, patients, or other individuals with person-specific, actionable recommendations or management options that are intelligently filtered or presented at appropriate times to enhance health and health care. CDSSs might be integrated with patient electronic health records (EHRs) and evidence-based knowledge. The Investigators designed a pragmatic randomized controlled trial to evaluate the effectiveness of patient-specific, point-of-care reminders generated by the Medilogy Decision Support System (MediDSS) on clinical practice and the quality of care in the Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS. The Investigators hypothesize that MediDSS reminders can increase clinician adherence to guidelines and, eventually, improve the quality of care offered to hospitalized patient. The adoption of CDSSs is likely to increase across healthcare systems due to growing concerns about the quality of medical care and discrepancy between real and ideal practice, continuous calls for a meaningful use of health information technology, and the increasing use of and familiarity with advanced technology among new generations of physicians.
Study Design:
The ONCO-CODES (Computerized DEcision Support in ONCOlogy) trial is a pragmatic, parallel group, randomized controlled study with 1:1 allocation ratio Study Duration 12 month Study Center(s) Single-center
Objectives:
The primary outcome of this trial is a process outcome. i.e. the rate at which the issues reported by the reminders are resolved (resolution rates).
Number of Subjects:
The investigators calculated the sample size on the basis of the primary outcome. A sample of 1,704 reminders will be necessary to detect the difference between the two groups (power = 0.90; α =0.05, two-sided; 1:1 allocation). Since estimates for intracluster correlation are not available, Implementing an evidence-based computerized decision support system linked to electronic health records to improve care for cancer patients.
Diagnosis and Main Inclusion Criteria:
The investigators will include all the patients admitted to the facilities of the IRST IRCCS. There are no exclusion criteria
Statistical Methodology:
All analyses will follow the intention-to-treat principle: patients will be analyzed in the group to which they have been randomized. Descriptive statistics will be presented.
All statistical tests will be two-sided. The investigators will use the Stata software to perform all statistical analyses (Stata Corp., College Station, TX, USA).The investigators increased the required sample size (by 20%) to 2,046 reminders to account for clustering by patient.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| computer reminders on clinical practice | Experimental | Other: computer reminders on clinical practiceon-screen, point-of-care computer reminders on clinical practice. |
| Control group | Other | Other: Control groupNo on-screen, point-of-care computer reminders on clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The Investigators will include all the EHRs of patients admitted to the facilities of the IRST IRCCS.
Key exclusion criteria (1 listed)
- There are no exclusion criteria.
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 |
|---|---|---|
| computer reminders on clinical practiceon-screen, point-of-care computer reminders on clinical practice. | Other | computer reminders on clinical practice |
| Control groupcontrol group | Other | Control group |
Primary outcome
resolution rates
Time frame: 12 months
the rate at which the issues reported by the reminders are resolved
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 9 Feb 2017.
- Derived from this study: PubMed 27884165Moja L, Passardi A, Capobussi M, Banzi R, Ruggiero F, Kwag K, Liberati EG, Mangia M, Kunnamo I, Cinquini M, Vespignani R, Colamartini A, Di Iorio V, Massa I, Gonzalez-Lorenzo M, Bertizzolo L, Nyberg P, Grimshaw J, Bonovas S, Nanni O. Implementing an evidence-based computerized decision support system linked to electronic health records to improve care for cancer patients: the ONCO-CODES study protocol for a randomized controlled trial. Implement Sci. 2016 Nov 25;11(1):153. doi: 10.1186/s13012-016-0514-3.
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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.
Alessandro Passardi, MD principal investigator
IRST IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing computer reminders on clinical practice in people with Medical Oncology, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS 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 9 Feb 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 NCT02645357, which also lists 1 linked publication.
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 9 Feb 2017.