Radiation Safety Alert
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Purpose
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 | Intervention |
|---|---|
|
Radiation Safety |
Other: Radiation Alert Other: Control |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) |
| Official Title: | Radiation Safety Alert- A Randomized Controlled Trial |
- Ordering behavior in response to alert [ Time Frame: After 6 months of data collection ] [ Designated as safety issue: Yes ]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.
- Appropriateness of Imaging Test Ordered in Response to Safety Alert [ Time Frame: After 6 months of data collection ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 2200 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | May 2011 |
| Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- All inpatient providers who order a CAT Scan
Exclusion Criteria:
- None
Contacts and Locations| United States, New York | |
| Montefiore Medical Center | |
| Bronx, New York, United States, 10467 | |
| Principal Investigator: | Stephen Amis, MD | Montefiore Medical Center |
| Study Director: | Jason S Adelman, MD, MS | Montefiore Medical Center |
More Information
Publications:
| Responsible Party: | Stephen Amis, M.D./University Chairman, Department of Radiology, Albert Einstein College of Medicine and Montefiore Medical Center |
| ClinicalTrials.gov Identifier: | NCT01268085 History of Changes |
| Other Study ID Numbers: | 10-10-330 |
| Study First Received: | December 15, 2010 |
| Last Updated: | December 28, 2010 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Keywords provided by Montefiore Medical Center:
|
Radiation Safety Computerized Physician Order Entry Decision Support Cat Scans |
ClinicalTrials.gov processed this record on May 21, 2013