Effectiveness of a Decision Support System in Improving the Diagnosis and Screening Rate of Breast Cancer
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
SEBASTIAN Clinical Decision Support System (CDSS)
Sponsored by

About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring Decision Support Techniques, Electronic Health Records, Reminder Systems, Early Detection of Cancer, Mammography, Women
Eligibility Criteria
Inclusion Criteria:
- Women between 50 and 69 years old
Exclusion Criteria:
- Breast Neoplasms
- Bilateral mastectomy
- Disabled Persons
Sites / Locations
- Hospital Italiano de Buenos AiresRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Electronic Reminder
control
Arm Description
alert from SEBASTIAN decision support system
Outcomes
Primary Outcome Measures
Number of participants with new Breast Neoplasms Diagnosis (Incident cases)
New Breast Neoplasms Diagnosis (Incident cases from biopsy reports). Breast Neoplasms are stored in the institutional Clinical Data Repository. The diagnosis are automatically codified using a terminology server that use SNOMED-CT as reference terminology
Secondary Outcome Measures
Number of patient with breast cancer screening due that received the order to perform the study (mammography)
Number of patient with breast cancer screening due that received the order to perform the study (mammography). This information will be record through the clinical data repository every time that a provider order a screening test to each of the patients involve in the study
Full Information
NCT ID
NCT01336257
First Posted
April 14, 2011
Last Updated
April 13, 2012
Sponsor
Hospital Italiano de Buenos Aires
Collaborators
Duke University
1. Study Identification
Unique Protocol Identification Number
NCT01336257
Brief Title
Effectiveness of a Decision Support System in Improving the Diagnosis and Screening Rate of Breast Cancer
Official Title
Effectiveness of a Decision Support System in Improving the Diagnosis and Screening Rate of Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Italiano de Buenos Aires
Collaborators
Duke University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Clinical decision support has been shown to improve the performance of screening tests; however, few studies have documented direct clinical benefit resulting from the increased screening promoted by clinical decision support systems.
The purpose of this study was to determine if a standards-based, sophisticated decision support system could not only promote additional breast cancer screening, but also detect significantly more breast cancer
Detailed Description
Breast cancer is the most common female cancer. In the United States, the second most common cause of cancer death in women, and the main cause of death in women ages 45 to 55 years old. The U.S. Preventive Services Task Force recommends screening mammography, with or without clinical breast examination, every one to two years among women aged 50 to 69 years old.
Recent research has shown that health care delivered in industrialized nations often falls short of optimal, evidence based care. US adults receive only about half of recommended care. To address these deficiencies in care, health-care organizations are increasingly turning to clinical decision support systems. A clinical decision-support system is any computer program designed to help health-care professionals to make clinical decisions. In a sense, any computer system that deals with clinical data or knowledge is intended to provide decision support.
Examples include manual or computer based systems that attach care reminders to the charts of patients needing specific preventive care services and computerized physician order entry systems that provide patient-specific recommendations as part of the order entry process. Such systems have been shown to improve prescribing practices, reduce serious medication errors, enhance the delivery of preventive care services, and improve adherence to recommended care standards.
The aim of this study is to show the efficacy of a decision-support system as a strategy for improving the performance of the mammography care process and the detection of significantly more breast cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Decision Support Techniques, Electronic Health Records, Reminder Systems, Early Detection of Cancer, Mammography, Women
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Electronic Reminder
Arm Type
Experimental
Arm Description
alert from SEBASTIAN decision support system
Arm Title
control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
SEBASTIAN Clinical Decision Support System (CDSS)
Intervention Description
SEBASTIAN is an example of a clinical decision support technology that supports the latest, service-based architectural approach to CDSS implementation. Developed at Duke University, SEBASTIAN is a clinical decision support Web service whose interface is now the basis of the HL7 Decision Support Service draft standard SEBASTIAN places a standardized interface in front of clinical decision support knowledge modules and makes only limited demands on how relevant patient data are collected or on how decision support inferences are communicated to end-users
Primary Outcome Measure Information:
Title
Number of participants with new Breast Neoplasms Diagnosis (Incident cases)
Description
New Breast Neoplasms Diagnosis (Incident cases from biopsy reports). Breast Neoplasms are stored in the institutional Clinical Data Repository. The diagnosis are automatically codified using a terminology server that use SNOMED-CT as reference terminology
Time Frame
18 month
Secondary Outcome Measure Information:
Title
Number of patient with breast cancer screening due that received the order to perform the study (mammography)
Description
Number of patient with breast cancer screening due that received the order to perform the study (mammography). This information will be record through the clinical data repository every time that a provider order a screening test to each of the patients involve in the study
Time Frame
18 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women between 50 and 69 years old
Exclusion Criteria:
Breast Neoplasms
Bilateral mastectomy
Disabled Persons
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Damian A Borbolla, MD
Organizational Affiliation
Hospital Italiano de Buenos Aires
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Italiano de Buenos Aires
City
Buenos Aires
ZIP/Postal Code
1209
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana M Gomez, MD
Phone
541149590200
Ext
5398
Email
anamaria.gomez@hospitalitaliano.org.ar
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of a Decision Support System in Improving the Diagnosis and Screening Rate of Breast Cancer
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