CT DOSE Collaboratory

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Ionizing Radiation Exposure; Quality Improvement	Other: Simple Audit Report; Other: Multi-Component Intervention; Other: In-Person Meeting	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	1200000 participants
Allocation:	Randomized
Intervention Model:	Factorial Assignment
Masking:	None (Open Label)
Primary Purpose:	Health Services Research
Official Title:	CT Dose Optimization and Standardization Endeavor (DOSE) Collaboratory
Study Start Date :	September 2014
Estimated Primary Completion Date :	December 2019
Estimated Study Completion Date :	December 2019

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: Track A; Simple Audit Report In-Person Meeting Multi-Component Intervention	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.
Active Comparator: Track B; In-Person Meeting Simple Audit Report Multi-Component Intervention	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.
Track C; Simple Audit Report Multi-Component Intervention	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).

Outcome Measures

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Primary Outcome Measures :

1. 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.
2. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.
11. 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.
12. 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.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	up to 99 Years (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

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Sponsors and Collaborators

University of California, San Francisco

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

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
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

  Study Documents (Full-Text)

Documents provided by Rebecca Smith-Bindman, University of California, San Francisco:

Study Protocol and Statistical Analysis Plan  [PDF] August 29, 2017

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

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. 

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Responsible Party:	Rebecca Smith-Bindman, Professor in Residence, University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT03000751 History of Changes
Other Study ID Numbers:	RSB-181191; R01CA181191 ( U.S. NIH Grant/Contract )
First Posted:	December 22, 2016
Last Update Posted:	September 5, 2017
Last Verified:	August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Rebecca Smith-Bindman, University of California, San Francisco:

CT scan; CT exam; ionizing radiation	medical imaging; cat scan; radiation