Study Stopped
Error in randomization resulted in early study termination.
Radiation Safety Alert
1 other identifier
interventional
15,969
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2010
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 15, 2010
CompletedFirst Posted
Study publicly available on registry
December 29, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedJune 8, 2018
June 1, 2018
9 months
December 15, 2010
June 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Appropriateness of Imaging Test Ordered in Response to Safety Alert
After 6 months of data collection
Study Arms (2)
Radiation Safety Alert
EXPERIMENTALA 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.
Control
ACTIVE COMPARATORParallel control with no intervention
Interventions
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
Eligibility Criteria
You may qualify if:
- All inpatient providers who order a CAT Scan
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Montefiore Medical Center
The Bronx, New York, 10467, United States
Related Publications (2)
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.
PMID: 17467608BACKGROUNDGoske 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.
PMID: 20102697BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen Amis, MD
Montefiore Medical Center
- STUDY DIRECTOR
Jason S Adelman, MD, MS
Montefiore Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2010
First Posted
December 29, 2010
Study Start
December 1, 2010
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
June 8, 2018
Record last verified: 2018-06