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CT DOSE Collaboratory

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03000751
Recruitment Status : Active, not recruiting
First Posted : December 22, 2016
Last Update Posted : March 25, 2020
Sponsor:
Collaborators:
University of California, Davis
University Hospital, Basel, Switzerland
Center for Diagnostic Imaging
Community Health Network
Children's Mercy Hospital Kansas City
City of Hope Medical Center
Albert Einstein Healthcare Network
Universität Duisburg-Essen
East Texas Medical Center Regional Healthcare System
Emory University
Henry Ford Health System
Huntsville Hospital Health System
Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Mount Sinai Hospital, New York
Maastricht University Medical Center
Olive View-UCLA Education & Research Institute
Oxford University Hospitals NHS Trust
San Francisco VA Health Care System
St. Joseph Hospital of Orange
St. Luke's International Hospital, Japan
University of Virginia
University of California, Irvine
University of California, San Diego
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE December 12, 2016
First Posted Date  ICMJE December 22, 2016
Last Update Posted Date March 25, 2020
Actual Study Start Date  ICMJE July 2016
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2017)
  • Mean Effective Dose (ED) [ Time Frame: First: 3-6 months post-audit versus 9-12 months prior to audit (excluding the 4-week post-audit period as a washout). Second: 3-6 months post MCI versus 2-6 months prior to MCI (excluding the 2-week post MCI as a washout). ]
    We will assess the change in the mean effective dose after the audit and multicomponent interventions (MCI) in comparison to before the audit and multicomponent interventions.
  • Proportion of CT scans with an Effective dose above benchmarks [ Time Frame: First: 3-6 months post-audit versus 9-12 months prior to audit (excluding the 4-week post-audit period as a washout). Second: 3-6 months post MCI versus 2-6 months prior to MCI (excluding the 2-week post MCI as a washout). ]
    We will assess the change in the proportion of examinations with an effective dose above the benchmark after the audit and after MCI in comparison to doses before the audit and MCI. The benchmark for each anatomic area is defined as the 75th percentile of the dose distribution during the pre-intervention period.
Original Primary Outcome Measures  ICMJE
 (submitted: December 19, 2016)
  • Change in mean Effective Dose (ED) after Simple Audit Report [ Time Frame: 4 weeks ]
  • Change in mean Effective Dose (ED) after Multi-Component Intervention [ Time Frame: 4 weeks ]
  • Change in mean Effective Dose (ED) after Simple Audit Report [ Time Frame: 12 weeks ]
  • Change in mean Effective Dose (ED) after Multi-Component Intervention [ Time Frame: 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2019)
  • Mean Dose length product [ Time Frame: First: 3-6 months post-audit versus 9-12 months prior to audit (excluding the 4-week post-audit period as a washout). Second: 3-6 months post MCI versus 2-6 months prior to MCI (excluding the 2-week post MCI as a washout). ]
    We will assess the change in the dose length product after the audit and MCI in comparison to before the audit and MCI.
  • Proportion of CT scans with a dose length product above benchmark [ Time Frame: First: 3-6 months post-audit versus 9-12 months prior to audit (excluding the 4-week post-audit period as a washout). Second: 3-6 months post MCI versus 2-6 months prior to MCI (excluding the 2-week post MCI as a washout). ]
    We will assess the change in the proportion of examinations with a dose length product above the benchmark after the audit and after the MCI in comparison to doses before the audit and MCI. The benchmark for each anatomic area is defined as the 75th percentile of the dose distribution during the pre intervention period.
  • Mean CTDIvol [ Time Frame: First: 3-6 months post-audit versus 9-12 months prior to audit (excluding the 4-week post-audit period as a washout). Second: 3-6 months post MCI versus 2-6 months prior to MCI (excluding the 2-week post MCI as a washout). ]
    We will assess the change in the CTDIvol after the audit and MCI in comparison to before the audit and multicomponent intervention.
  • Proportion of CT scans with a CTDIvol above benchmark [ Time Frame: First: 3-6 months post-audit versus 9-12 months prior to audit (excluding the 4-week post-audit period as a washout). Second: 3-6 months post MCI versus 2-6 months prior to MCI (excluding the 2-week post MCI as a washout). ]
    We will assess the change in the proportion of examinations with a CTDIvol above the benchmark after the audit and after multicomponent intervention in comparison to doses before the audit and multicomponent intervention. The benchmark for each anatomic area is defined as the 75th percentile of the dose distribution during the pre intervention period.
  • Mean Effective dose [ Time Frame: 12-15 mos post-MCI versus: 9-12 months before the audit and 3-6 months after the audit (allowing for a 4 week washout period) and 2-6 months prior to MCI and 3-6 months post-MCI (allowing a 2-week washout period). ]
    We will assess the delayed effects of the intervention on mean effective dose.
  • Proportion of examinations with an Effective dose above the benchmark [ Time Frame: 12-15 mos post-MCI versus: 9-12 months before the audit and 3-6 months after the audit (allowing for a 4 week washout period) and 2-6 months prior to MCI and 3-6 months post-MCI (allowing a 2-week washout period). ]
    We will assess the delayed effects of the intervention on the proportion of examinations with an effective dose above the benchmark.
  • Mean Dose Length Product [ Time Frame: 12-15 mos post-MCI versus: 9-12 months before the audit and 3-6 months after the audit (allowing for a 4 week washout period) and 2-6 months prior to MCI and 3-6 months post-MCI (allowing a 2-week washout period). ]
    We will assess the delayed effects of the intervention on mean Dose Length Product.
  • Proportion of examinations with a Dose Length Product above the benchmark [ Time Frame: 12-15 mos post-MCI versus: 9-12 months before the audit and 3-6 months after the audit (allowing for a 4 week washout period) and 2-6 months prior to MCI and 3-6 months post-MCI (allowing a 2-week washout period). ]
    We will assess the delayed effects of the intervention on the proportion of examinations with a Dose Length Product above the benchmark.
  • Mean CTDIvol [ Time Frame: 12-15 mos post-MCI versus: 9-12 months before the audit and 3-6 months after the audit (allowing for a 4 week washout period) and 2-6 months prior to MCI and 3-6 months post-MCI (allowing a 2-week washout period). ]
    We will assess the delayed effects of the intervention on mean effective dose.
  • Proportion of examinations with a CTDIvol above the benchmark [ Time Frame: 12-15 mos post-MCI versus: 9-12 months before the audit and 3-6 months after the audit (allowing for a 4 week washout period) and 2-6 months prior to MCI and 3-6 months post-MCI (allowing a 2-week washout period). ]
    We will assess the delayed effects of the intervention on the proportion of examinations with a CTDIvol above the benchmark.
  • Mean Effective Dose [ Time Frame: 3-6 months post-audit vs 9-12 months prior to audit (excluding 4-week washout); 3-6 months post MCI vs 2-6 months prior to MCI (excluding 2 week washout); 12-15 months post MCI vs 9-12 months before the audit and 2-6 months prior to MCI ]
    We will use mixed-methods approaches to identify facility-level factors (assessed through surveys of participating facilities) associated with effective dose levels and associated with successful and failed implementation of dose optimization.
  • Proportion of examinations with an effective dose above the benchmark [ Time Frame: 3-6 months post-audit vs 9-12 months prior to audit (excluding 4-week washout); 3-6 months post MCI vs 2-6 months prior to MCI (excluding 2 week washout); 12-15 months post MCI vs 9-12 months before the audit and 2-6 months prior to MCI ]
    We will use mixed-methods approaches to identify facility-level factors (assessed through surveys of participating facilities) associated with the proportion of examinations with effective dose above the benchmarks and associated with successful and failed implementation of dose optimization.
  • Organ Doses: Brain Dose for Head CT; Lung Dose For Chest CT; Colon and Liver Dose for Abdomen CT [ Time Frame: 3-6 months post-audit vs 9-12 months prior to audit (excluding 4-week washout); 3-6 months post MCI vs 2-6 months prior to MCI (excluding 2 week washout); 12-15 months post MCI vs 9-12 months before the audit and 2-6 months prior to MCI ]
    The organ doses most closely reflect the areas that receive dose from any given CT scan and thus are a more direct reflecting of the CT settings. They also will be more highly correlated with future cancer risk
Original Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2016)
  • Change in mean Computerized Tomography Dose Index Volume (CTDIvol) after Simple Audit Report [ Time Frame: 4 weeks ]
  • Change in mean Computerized Tomography Dose Index Volume (CTDIvol) after Simple Audit Report [ Time Frame: 12 weeks ]
  • Change in mean Computerized Tomography Dose Index Volume (CTDIvol) after Multi-Component Intervention [ Time Frame: 4 weeks ]
  • Change in mean Computerized Tomography Dose Index Volume (CTDIvol) after Multi-Component Intervention [ Time Frame: 12 weeks ]
  • Change in mean Dose Length Product (DLP) after Simple Audit Report [ Time Frame: 4 weeks ]
  • Change in mean Dose Length Product (DLP) after Simple Audit Report [ Time Frame: 12 weeks ]
  • Change in mean Dose Length Product (DLP) after Multi-Component Intervention [ Time Frame: 4 weeks ]
  • Change in mean Dose Length Product (DLP) after Multi-Component Intervention [ Time Frame: 12 weeks ]
  • Change in mean Size-Specific Dose Estimate (SSDE) after Simple Audit Report [ Time Frame: 4 weeks ]
  • Change in mean Size-Specific Dose Estimate (SSDE) after Simple Audit Report [ Time Frame: 12 weeks ]
  • Change in mean Size-Specific Dose Estimate (SSDE) after Multi-Component Intervention [ Time Frame: 4 weeks ]
  • Change in mean Size-Specific Dose Estimate (SSDE) after Multi-Component Intervention [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CT DOSE Collaboratory
Official Title  ICMJE CT Dose Optimization and Standardization Endeavor (DOSE) Collaboratory
Brief Summary

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.

Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Ionizing Radiation Exposure
  • Quality Improvement
Intervention  ICMJE
  • Other: Simple Audit Report
    The simple audit provides comparison and feedback on radiation doses.
  • 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).
  • Other: In-Person Meeting
    Collaborator meeting with an emphasis on quality improvement.
Study Arms  ICMJE
  • Active Comparator: Track A
    Simple Audit Report In-Person Meeting Multi-Component Intervention
    Interventions:
    • Other: Simple Audit Report
    • Other: Multi-Component Intervention
    • Other: In-Person Meeting
  • Active Comparator: Track B
    In-Person Meeting Simple Audit Report Multi-Component Intervention
    Interventions:
    • Other: Simple Audit Report
    • Other: Multi-Component Intervention
    • Other: In-Person Meeting
  • Track C
    Simple Audit Report Multi-Component Intervention
    Interventions:
    • Other: Simple Audit Report
    • Other: Multi-Component Intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: August 14, 2017)
1200000
Original Estimated Enrollment  ICMJE
 (submitted: December 19, 2016)
2840000
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 99 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03000751
Other Study ID Numbers  ICMJE RSB-181191
R01CA181191 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE
  • University of California, Davis
  • University Hospital, Basel, Switzerland
  • Center for Diagnostic Imaging
  • Community Health Network
  • Children's Mercy Hospital Kansas City
  • City of Hope Medical Center
  • Albert Einstein Healthcare Network
  • Universität Duisburg-Essen
  • East Texas Medical Center Regional Healthcare System
  • Emory University
  • Henry Ford Health System
  • Huntsville Hospital Health System
  • Nicklaus Children's Hospital f/k/a Miami Children's Hospital
  • Mount Sinai Hospital, New York
  • Maastricht University Medical Center
  • Olive View-UCLA Education & Research Institute
  • Oxford University Hospitals NHS Trust
  • San Francisco VA Health Care System
  • St. Joseph Hospital of Orange
  • St. Luke's International Hospital, Japan
  • University of Virginia
  • University of California, Irvine
  • University of California, San Diego
  • National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Rebecca Smith-Bindman, MD University of California, San Francisco
Principal Investigator: Judy Yee, MD San Francisco Veterans Administration
Principal Investigator: Tom Nelson, PhD University of California, San Diego
Principal Investigator: Tony Seibert, PhD University of California, Davis
Principal Investigator: Mayil Krishnam, MD University of California, Irvine
Principal Investigator: Michael Flynn, PhD Henry Ford Health System
Principal Investigator: Mary Cocker, MSc, Csci Oxford University Hospitals NHS Trust
Principal Investigator: William Boswell, MD City of Hope Medical Center
Principal Investigator: Sebastian Schindera, MD University Hospital of Basel
Principal Investigator: Erin Bell, MHP Community Health Network
Principal Investigator: Phuong-Anh Duong, MD Emory University
Principal Investigator: Nima Kasraie, PhD, MSc Children's Mercy Hospital Kansas City
Principal Investigator: Pavlina Pike, PhD Huntsville Hospital
Principal Investigator: Luisa Cervantes, MD Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Principal Investigator: Joachim Wildberger, PhD Maastricht University Medical Center
Principal Investigator: Michael Forsting, MD University of Duisburg-Essen
Principal Investigator: Fady Kassem, PhD St. Joseph Hospital of Orange
Principal Investigator: Darrell Fendrick, CT East Texas Medical Center
Principal Investigator: Sugoto Mukherjee, MD University of Virginia Health System
Principal Investigator: Brad Delman, MD Icahn School of Medicine at Mount Sinai
Principal Investigator: Jodi Roehm Center for Diagnostic Imaging
Principal Investigator: Anokh Pahwa, MD Olive View - UCLA
Principal Investigator: Ryan Lee, MD, MBA Einstein Medical Center
Principal Investigator: Jay Starkey, MD St. Luke's International Hospital, Tokyo
Principal Investigator: Diana Miglioretti, PhD University of California, Davis
Principal Investigator: Saravanabavaan Suntharalingam, MD University of Duisburg-Essen
Principal Investigator: Sara Lewis, MD Icahn School of Medicine at Mount Sinai
PRS Account University of California, San Francisco
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP