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 : Unknown
Verified March 2020 by University of California, San Francisco.
Recruitment status was: Active, not recruiting
First Posted : December 22, 2016
Last Update Posted : March 25, 2020
|
- Study Details
- Tabular View
- Results Submitted
- Disclaimer
- How to Read a Study Record
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 |
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 : | 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 |
Actual Study Start Date : | July 2016 |
Estimated Primary Completion Date : | December 2020 |
Estimated Study Completion Date : | December 2020 |
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). |
- 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.
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | up to 99 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03000751
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 |
Documents provided by University of California, San Francisco:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT03000751 |
Other Study ID Numbers: |
RSB-181191 R01CA181191 ( U.S. NIH Grant/Contract ) |
First Posted: | December 22, 2016 Key Record Dates |
Last Update Posted: | March 25, 2020 |
Last Verified: | March 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
CT scan CT exam ionizing radiation |
medical imaging cat scan radiation |