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Implementing an Evidence-based Computerized Decision Support System Linked to Electronic Health Records to Improve Care for Cancer Patients

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)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02645357
Acronym
ONCO-CODES
Enrollment
15431
Registered
2016-01-01
Start date
2015-11-30
Completion date
2017-01-31
Last updated
2017-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medical Oncology

Keywords

Oncology Patients, evidence-based, computerized, decision, support system, linked, electronic health records

Brief 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 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.

Interventions

OTHERcomputer reminders on clinical practice

on-screen, point-of-care computer reminders on clinical practice.

OTHERControl group

control group

Sponsors

Ministry of Health, Italy
CollaboratorOTHER_GOV
University of Milan
CollaboratorOTHER
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
CollaboratorOTHER
Catholic University of the Sacred Heart
CollaboratorOTHER
Duodecim, Finnish Medical Association, Helsinki
CollaboratorUNKNOWN
Mario Negri Institute for Pharmacological Research
CollaboratorOTHER
Ottawa Hospital Research Institute
CollaboratorOTHER
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* The Investigators will include all the EHRs of patients admitted to the facilities of the IRST IRCCS.

Exclusion criteria

* There are no

Design outcomes

Primary

MeasureTime frameDescription
resolution rates12 monthsthe rate at which the issues reported by the reminders are resolved

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026