NCT02645357

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15,431

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

Study Start

First participant enrolled

November 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 31, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 1, 2016

Completed
11 months 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

February 9, 2017

Status Verified

February 1, 2017

Enrollment Period

1.1 years

First QC Date

December 31, 2015

Last Update Submit

February 8, 2017

Conditions

Medical Oncology

Keywords

Oncology Patientsevidence-basedcomputerizeddecisionsupport systemlinkedelectronic health records

Outcome Measures

Primary Outcomes (1)

  • resolution rates

    the rate at which the issues reported by the reminders are resolved

    12 months

Study Arms (2)

computer reminders on clinical practice

EXPERIMENTAL

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

Other: computer reminders on clinical practice

Control group

OTHER

No on-screen, point-of-care computer reminders on clinical practice.

Other: Control group

Interventions

computer reminders on clinical practiceOTHER

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

computer reminders on clinical practice
Control groupOTHER

control group

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oncologia Medica, IRST IRCCS, Meldola

Meldola, 47014, Italy

Location

Related Publications (1)

  • 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.

    PMID: 27884165DERIVED

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Alessandro Passardi, MD

    IRST IRCCS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 31, 2015

First Posted

January 1, 2016

Study Start

November 1, 2015

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

February 9, 2017

Record last verified: 2017-02

Locations

IT(1)