Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
864080 participants
Study Classification
INTERVENTIONAL
Study Start Date
2016-07-31
Study Completion Date
2020-12-31
Brief Summary
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This is a pragmatic stepped-wedge cluster randomized controlled trial to explore variation in doses used for diagnostic CT by pooling radiation dose data across diverse healthcare delivery systems.
To compare different strategies for lowering and optimizing dose and identify the barriers and facilitators to implementing successful dose optimization strategies and standardizing practice.
To compare different strategies for lowering and optimizing dose and identify the barriers and facilitators to implementing successful dose optimization strategies and standardizing practice.
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Detailed Description
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The investigators are using a stepped-wedge cluster randomized controlled trial, collecting radiation dose information on CT from across all collaborating health care facilities, and leading several different interventions to optimize dose across facilities. In addition to collecting the CT radiation dose data, and using these results to provide feedback to the collaborating health care facilities, they will be conducting surveys of several individuals at each site, including key informants, such as lead radiologists, technologists, and medical physicist, and radiology administrators.
They will compare and identify facilitators and barriers (assessed through surveys of participating facilities) associated with successful and failed implementation of dose optimization.
They will compare and identify facilitators and barriers (assessed through surveys of participating facilities) associated with successful and failed implementation of dose optimization.
Conditions
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Ionizing Radiation Exposure
Quality Improvement
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
FACTORIAL
Primary Study Purpose
HEALTH_SERVICES_RESEARCH
Blinding Strategy
NONE
Study Groups
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Track A
Simple Audit Report; In-Person Meeting (timed to coincide with the multi-component intervention); Multi-Component Intervention
Group Type
ACTIVE_COMPARATOR
Simple Audit Report
Intervention Type
OTHER
The simple audit provides comparison and feedback on radiation doses.
Multi-Component Intervention
Intervention Type
OTHER
The multi-component intervention gives tailored feedback on needed changes plus guidance using quality improvement methods that facilitate organizational change. Provides access to experts, detailed audit, collaborative calls, and site visits (as needed).
In-Person Meeting
Intervention Type
OTHER
Collaborator meeting with an emphasis on quality improvement.
Track B
In-Person Meeting (timed to coincide with the simple audit report); Simple Audit Report; Multi-Component Intervention
Group Type
ACTIVE_COMPARATOR
Simple Audit Report
Intervention Type
OTHER
The simple audit provides comparison and feedback on radiation doses.
Multi-Component Intervention
Intervention Type
OTHER
The multi-component intervention gives tailored feedback on needed changes plus guidance using quality improvement methods that facilitate organizational change. Provides access to experts, detailed audit, collaborative calls, and site visits (as needed).
In-Person Meeting
Intervention Type
OTHER
Collaborator meeting with an emphasis on quality improvement.
Track C
Simple Audit Report; Multi-Component Intervention
Group Type
OTHER
Simple Audit Report
Intervention Type
OTHER
The simple audit provides comparison and feedback on radiation doses.
Multi-Component Intervention
Intervention Type
OTHER
The multi-component intervention gives tailored feedback on needed changes plus guidance using quality improvement methods that facilitate organizational change. Provides access to experts, detailed audit, collaborative calls, and site visits (as needed).
Interventions
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Simple Audit Report
The simple audit provides comparison and feedback on radiation doses.
Intervention Type
OTHER
Multi-Component Intervention
The multi-component intervention gives tailored feedback on needed changes plus guidance using quality improvement methods that facilitate organizational change. Provides access to experts, detailed audit, collaborative calls, and site visits (as needed).
Intervention Type
OTHER
In-Person Meeting
Collaborator meeting with an emphasis on quality improvement.
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* Diagnostic CT scans of the head, chest, and/or abdomen/pelvis performed within the study period
Exclusion Criteria
* non-diagnostic scans that are not of the head, chest, and/or abdomen/pelvis
Maximum Eligible Age
99 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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University of California, Davis
OTHER
Sponsor Role
collaborator
University Hospital, Basel, Switzerland
OTHER
Sponsor Role
collaborator
Center for Diagnostic Imaging
OTHER
Sponsor Role
collaborator
Community Health Network
OTHER
Sponsor Role
collaborator
Children's Mercy Hospital Kansas City
OTHER
Sponsor Role
collaborator
City of Hope Medical Center
OTHER
Sponsor Role
collaborator
Albert Einstein Healthcare Network
OTHER
Sponsor Role
collaborator
Universität Duisburg-Essen
OTHER
Sponsor Role
collaborator
East Texas Medical Center Regional Healthcare System
OTHER
Sponsor Role
collaborator
Emory University
OTHER
Sponsor Role
collaborator
Henry Ford Health System
OTHER
Sponsor Role
collaborator
Huntsville Hospital Health System
OTHER
Sponsor Role
collaborator
Nicklaus Children's Hospital f/k/a Miami Children's Hospital
OTHER
Sponsor Role
collaborator
Mount Sinai Hospital, New York
OTHER
Sponsor Role
collaborator
Maastricht University Medical Center
OTHER
Sponsor Role
collaborator
Olive View-UCLA Education & Research Institute
OTHER
Sponsor Role
collaborator
Oxford University Hospitals NHS Trust
OTHER
Sponsor Role
collaborator
San Francisco VA Health Care System
FED
Sponsor Role
collaborator
St. Joseph Hospital of Orange
OTHER
Sponsor Role
collaborator
St. Luke's International Hospital, Japan
OTHER
Sponsor Role
collaborator
University of Virginia
OTHER
Sponsor Role
collaborator
University of California, Irvine
OTHER
Sponsor Role
collaborator
University of California, San Diego
OTHER
Sponsor Role
collaborator
National Cancer Institute (NCI)
NIH
Sponsor Role
collaborator
University of California, San Francisco
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Rebecca Smith-Bindman, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Judy Yee, MD
Role: PRINCIPAL_INVESTIGATOR
San Francisco Veterans Administration
Tom Nelson, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Tony Seibert, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, Davis
Mayil Krishnam, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Irvine
Michael Flynn, PhD
Role: PRINCIPAL_INVESTIGATOR
Henry Ford Health System
Mary Cocker, MSc, Csci
Role: PRINCIPAL_INVESTIGATOR
Oxford University Hospitals NHS Trust
William Boswell, MD
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Sebastian Schindera, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Basel
Erin Bell, MHP
Role: PRINCIPAL_INVESTIGATOR
Community Health Network
Phuong-Anh Duong, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Nima Kasraie, PhD, MSc
Role: PRINCIPAL_INVESTIGATOR
Children's Mercy Hospital Kansas City
Pavlina Pike, PhD
Role: PRINCIPAL_INVESTIGATOR
Huntsville Hospital
Luisa Cervantes, MD
Role: PRINCIPAL_INVESTIGATOR
Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Joachim Wildberger, PhD
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Medical Center
Michael Forsting, MD
Role: PRINCIPAL_INVESTIGATOR
University of Duisburg-Essen
Fady Kassem, PhD
Role: PRINCIPAL_INVESTIGATOR
St. Joseph Hospital of Orange
Darrell Fendrick, CT
Role: PRINCIPAL_INVESTIGATOR
East Texas Medical Center
Sugoto Mukherjee, MD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia Health System
Brad Delman, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Jodi Roehm
Role: PRINCIPAL_INVESTIGATOR
Center for Diagnostic Imaging
Anokh Pahwa, MD
Role: PRINCIPAL_INVESTIGATOR
Olive View - UCLA
Ryan Lee, MD, MBA
Role: PRINCIPAL_INVESTIGATOR
Einstein Medical Center
Jay Starkey, MD
Role: PRINCIPAL_INVESTIGATOR
St. Luke's International Hospital, Tokyo
Diana Miglioretti, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, Davis
Saravanabavaan Suntharalingam, MD
Role: PRINCIPAL_INVESTIGATOR
University of Duisburg-Essen
Sara Lewis, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
References
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Smith-Bindman R, Chu P, Wang Y, Chung R, Lopez-Solano N, Einstein AJ, Solberg L, Cervantes LF, Yellen-Nelson T, Boswell W, Delman BN, Duong PA, Goode AR, Kasraie N, Lee RK, Neill R, Pahwa A, Pike P, Roehm J, Schindera S, Starkey J, Suntharalingam S, Jeukens CRLPN, Miglioretti DL. Comparison of the Effectiveness of Single-Component and Multicomponent Interventions for Reducing Radiation Doses in Patients Undergoing Computed Tomography: A Randomized Clinical Trial. JAMA Intern Med. 2020 May 1;180(5):666-675. doi: 10.1001/jamainternmed.2020.0064.
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RESULT
Smith-Bindman R, Wang Y, Chu P, Chung R, Einstein AJ, Balcombe J, Cocker M, Das M, Delman BN, Flynn M, Gould R, Lee RK, Nelson TR, Schindera S, Seibert A, Starkey J, Suntharalingam S, Wetter A, Wildberger JE, Miglioretti DL. International variation in radiation dose for computed tomography examinations: prospective cohort study. BMJ. 2019 Jan 2;364:k4931. doi: 10.1136/bmj.k4931.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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http://ctdose.ucsf.edu
The website explores and focuses on studying the impact of medical imaging on health, minimizing the harms of medical imaging and and providing rigorous evidence to aid policymakers regarding use of medical imaging.
Other Identifiers
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RSB-181191
Identifier Type: -
Identifier Source: org_study_id
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Study on Sex-specific, Individualized Dose Calculation of Contrast Agent in CT Examinations
NCT06965790
RECRUITING
NA
CT Perfusion Changes in GI Cancer During Adenosine Vasodilation Test
NCT02074124
COMPLETED
Dosimetry Using a CZT-camera Following LUTATHERA® Therapy
NCT04467567
COMPLETED
NA
Prospective Randomized Trial On RadiaTion Dose Estimates Of CT AngIOgraphy In PatieNts Scanned With A 100kV Protocol
NCT00611780
UNKNOWN
PHASE4
Comparison of Contrast Agent Administration Protocols
NCT04300972
COMPLETED
NA
On Dose Efficiency of Modern CT-scanners in Chest Scans
NCT04996693
COMPLETED
NA
Imaging Techniques in CT: Technical Development
NCT02242448
TERMINATED
Safety and Performance of Optivantage Multi-use When Injecting Contrast Media for Contrast Enhanced CT Examination
NCT05537779
UNKNOWN
Breast Displacement and CT Radiation Dose
NCT01261559
COMPLETED
NA
Enhancement and Restoring of Low Dose Abdominal CT Images
NCT01059032
COMPLETED
PHASE1
CODP Imaging From a Dose Perspective
NCT03581110
COMPLETED
Low-dose Whole Body Computed Tomography Scanning
NCT03425032
COMPLETED
Dose Reduction in Thoracic CT
NCT00188461
COMPLETED
PHASE1
The Optimization of a Low-dose CT Protocol in Patients With Suspected Uncomplicated Acute Appendicitis and BMI >30
NCT04519086
SUSPENDED
NA
Coronary Computed Tomography for Systematic Triage of Acute Chest Pain Patients to Treatment (CT-STAT)
NCT00468325
COMPLETED
NA
Dosing Iodinated Contrast Media According to Lean vs. Total Body Weight
NCT03415997
COMPLETED
PHASE4
Low Tube Voltage Computed Tomographic (CT) Urography Using Low Concentration Iodine Contrast Agent
NCT01855204
UNKNOWN
NA
Multidetector Computed Tomography (MDCT) Tailored Protocol
NCT01737333
COMPLETED