Clinical trial NCT01336257: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: Decision Support Techniques
Electronic Health Records
Reminder Systems
Early Detection of Cancer
Mammography
Women
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
Collaborators: name: Duke University
First posted: 2011-04-15
Enrollment: 2200
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

* Women between 50 and 69 years old

Exclusion Criteria:

* Breast Neoplasms
* Bilateral mastectomy
* Disabled Persons

Primary outcomes:
measure: Number of participants with new Breast Neoplasms Diagnosis (Incident cases)
timeFrame: 18 month
Secondary outcomes:
measure: Number of patient with breast cancer screening due that received the order to perform the study (mammography)
timeFrame: 18 month
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
Study officials:
affiliation: Hospital Italiano de Buenos Aires
name: Damian A Borbolla, MD
role: PRINCIPAL_INVESTIGATOR
References: