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Radiation Safety Alert

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01268085
Recruitment Status : Terminated (Error in randomization resulted in early study termination.)
First Posted : December 29, 2010
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
Montefiore Medical Center

Brief Summary:

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.

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. 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 the investigators 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.


Condition or disease Intervention/treatment Phase
Radiation Safety Other: Radiation Alert Other: Control Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15969 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Official Title: Radiation Safety Alert- A Randomized Controlled Trial
Actual Study Start Date : December 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Arm Intervention/treatment
Experimental: Radiation Safety Alert
A provider placing an electronic order for a CAT scan will receive a radiation safety pop-up alert with a message about the dangers of cumulative ionizing radiation, the patient's cumulative CAT scan history, and the most recent imaging test from any modality of the same body part.
Other: Radiation Alert
A radiation safety pop-up alert with a message about the dangers of cumulative ionizing radiation, the patient's cumulative CAT scan history, and the most recent imaging test from any modality of the same body part

Active Comparator: Control
Parallel control with no intervention
Other: Control
Control with no inverention




Primary Outcome Measures :
  1. Ordering behavior in response to alert [ Time Frame: After 6 months of data collection ]
    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.


Secondary Outcome Measures :
  1. Appropriateness of Imaging Test Ordered in Response to Safety Alert [ Time Frame: After 6 months of data collection ]
    Decisions to proceed with the CAT scan order, choose an alternative or cancel the order will be evaluated for appropriateness by retrospective chart review by two independent radiologists. Discrepancies will be resolved by consensus.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All inpatient providers who order a CAT Scan

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01268085


Locations
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United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
Investigators
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Principal Investigator: Stephen Amis, MD Montefiore Medical Center
Study Director: Jason S Adelman, MD, MS Montefiore Medical Center
Publications:
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Responsible Party: Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01268085    
Other Study ID Numbers: 10-10-330
First Posted: December 29, 2010    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: June 2018
Keywords provided by Montefiore Medical Center:
Radiation Safety
Computerized Physician Order Entry
Decision Support
Cat Scans