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Radiation Safety Alert- A Randomized Controlled Trial


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Radiation Safety

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Trial Information

Radiation Safety Alert- A Randomized Controlled Trial


Ever since the 1979 Nobel Prize was awarded to Cormack and Hounsfield for the development of
computer assisted tomography (CAT scans, this technology has revolutionized the practice of
medicine. CAT scans combine special x-ray equipment with sophisticated computers to
produce images of the inside of the body. They are widely used, noninvasive medical tests
that help physicians diagnose and treat numerous medical conditions. In 2000, the U.S. Food
and Drug Administration (FDA) and the Conference of Radiation Control Program Directors
(CRCPD) estimated that approximately 40 million CAT scans are performed annually.

In recent years, multiple articles have highlighted the increased risk of developing cancer
from ionizing radiation. The risk increases with higher radiation doses, and accumulates
with repeated scans. The 2007 American College of Radiology's white paper on radiation dose
in medicine by Amis, et al., emphasizes the importance of addressing this issue, and
proposes a plan to educate all stakeholders in the principles of radiation safety and
appropriate utilization of imaging. In addition, in 2007 the Society for Pediatric
Radiology joined forces with the American College of Radiology and several other medical
societies to form the Alliance for Radiation Safety in Pediatric Imaging (the Image Gently
Alliance). The charge of the Alliance is summarized in its mission statement: "…to raise
awareness in the imaging community of the need to adjust radiation dose when imaging
children."

Hospitals with computerized physician order entry systems (CPOE) have the unique opportunity
to use decision support on radiation safety to influence a physician's ordering practice in
real-time. CPOE and decision support technology have been successfully used to positively
effect physician ordering behavior and improve patient safety in many aspects of patient
care, including the ordering of radiology tests. An ideal decision support tool for
radiation safety will educate the physician about the dangers of cumulative ionizing
radiation, present the patient's image history, and guide the provider to the best modality
that meets the patient's diagnostic needs with as little radiation exposure as possible.
The design challenge is to create a decision support tool that appropriately protects our
patients from overutilization of CAT scans, without inadvertently leading to
underutilization of CAT scans or inappropriate utilization of alternative tests. This
research protocol proposes to study one such design at a large, academic medical center.


Inclusion Criteria:



- All inpatient providers who order a CAT Scan

Exclusion Criteria:

- None

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Outcome Measure:

Ordering behavior in response to alert

Outcome Description:

The proportion of patients that continue on with the CAT scan order, choose an alternative, or cancel the order in response to the radiation safety alert, as compared to control.

Outcome Time Frame:

After 6 months of data collection

Safety Issue:

Yes

Principal Investigator

Stephen Amis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Montefiore Medical Center

Authority:

United States: Institutional Review Board

Study ID:

10-10-330

NCT ID:

NCT01268085

Start Date:

December 2010

Completion Date:

May 2011

Related Keywords:

  • Radiation Safety
  • Radiation Safety
  • Computerized Physician Order Entry
  • Decision Support
  • Cat Scans

Name

Location

Montefiore Medical Center Bronx, New York  10467-2490