Radiation Safety Alert

Radiation Safety Alert- A Randomized Controlled Trial

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.

Study Overview

• Status: Terminated
• Conditions: Radiation Safety
• Intervention / Treatment: Other: Radiation Alert; Other: Control

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.

• Study Type: Interventional
• Enrollment (Actual): 15969
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All inpatient providers who order a CAT Scan

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Parallel control with no intervention	Other: Control; Control with no inverention
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ordering behavior in response to alert	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.	After 6 months of data collection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Appropriateness of Imaging Test Ordered in Response to Safety Alert	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.	After 6 months of data collection

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Investigators: Principal Investigator: Stephen Amis, MD, Montefiore Medical Center; Study Director: Jason S Adelman, MD, MS, Montefiore Medical Center

Publications and helpful links

General Publications

• Amis ES Jr, Butler PF, Applegate KE, Birnbaum SB, Brateman LF, Hevezi JM, Mettler FA, Morin RL, Pentecost MJ, Smith GG, Strauss KJ, Zeman RK; American College of Radiology. American College of Radiology white paper on radiation dose in medicine. J Am Coll Radiol. 2007 May;4(5):272-84. doi: 10.1016/j.jacr.2007.03.002.
• Goske MJ, Applegate KE, Bell C, Boylan J, Bulas D, Butler P, Callahan MJ, Coley BD, Farley S, Frush DP, McElveny C, Hernanz-Schulman M, Johnson ND, Kaste SC, Morrison G, Strauss KJ. Image Gently: providing practical educational tools and advocacy to accelerate radiation protection for children worldwide. Semin Ultrasound CT MR. 2010 Feb;31(1):57-63. doi: 10.1053/j.sult.2009.09.007.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2010
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: December 15, 2010
• First Submitted That Met QC Criteria: December 28, 2010
• First Posted (Estimate): December 29, 2010

Study Record Updates

• Last Update Posted (Actual): June 8, 2018
• Last Update Submitted That Met QC Criteria: June 6, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Decision Support; Computerized Physician Order Entry; Radiation Safety; Cat Scans
• Other Study ID Numbers: 10-10-330