NCT01268085

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

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15,969

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2010

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 29, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

June 8, 2018

Status Verified

June 1, 2018

Enrollment Period

9 months

First QC Date

December 15, 2010

Last Update Submit

June 6, 2018

Conditions

Keywords

Radiation SafetyComputerized Physician Order EntryDecision SupportCat Scans

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

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

Parallel control with no intervention

Other: Control

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

Radiation Safety Alert
ControlOTHER

Control with no inverention

Control

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Location

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: 17467608BACKGROUND
  • 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.

    PMID: 20102697BACKGROUND

Study Officials

  • Stephen Amis, MD

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR
  • Jason S Adelman, MD, MS

    Montefiore Medical Center

    STUDY DIRECTOR

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

Locations