CT DOSE Collaboratory

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.

• Simple Audit Report (Other): The simple audit provides comparison and feedback on radiation doses.
• Multi-Component Intervention (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 (Other): Collaborator meeting with an emphasis on quality improvement.

Primary outcomes

• Change in Mean Effective Dose (ED) [Sites were randomized to 1 of 3 tracks, which determined the timing of intervention: Track A: audit at week 40, MCI at week 68 Track B: audit at week 44, MCI at week 74 Track C: audit at week 53, MCI at week 81]: We will assess the change in the mean effective dose after the simple audit and multi-component interventions (MCI) in comparison to before the audit and multi-component interventions. The numbers given below reflect absolute change in mean dose (in millisieverts) relative to the baseline period.
• Percentage of CT Scans With an Effective Dose Above Benchmark [Sites were randomized to 1 of 3 tracks, which determined the timing of intervention: Track A: audit at week 40, MCI at week 68 Track B: audit at week 44, MCI at week 74 Track C: audit at week 53, MCI at week 81]: We will assess the change in the percentage of examinations with an effective dose above the benchmark after the simple audit and after multi-component intervention (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 (baseline) period.

Secondary outcomes

• Mean Dose Length Product [Sites were randomized to 1 of 3 tracks, which determined the timing of intervention: Track A: audit at week 40, MCI at week 68 Track B: audit at week 44, MCI at week 74 Track C: audit at week 53, MCI at week 81]: 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 [Sites were randomized to 1 of 3 tracks, which determined the timing of intervention: Track A: audit at week 40, MCI at week 68 Track B: audit at week 44, MCI at week 74 Track C: audit at week 53, MCI at week 81]: 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.
• Change in Mean Volume Computed Tomography Dose Index (CTDIvol) [Sites were randomized to 1 of 3 tracks, which determined the timing of intervention: Track A: audit at week 40, MCI at week 68 Track B: audit at week 44, MCI at week 74 Track C: audit at week 53, MCI at week 81]: We will assess the change in the mean volume CT dose index (CTDIvol) from before versus after the audit and MCI intervention. CTDIvol (in units of milligray, mGy) is a measure of radiation dose, reflecting the amount of radiation imparted per CT slice by the scanner. Higher CTDIvol signifies more radiation dose. In general, a reduction in CTDIvol would be a sign of quality improvement, minimizing excess radiation exposure to the patient.
• Percentage of CT Scans With a CTDIvol Above Benchmark [Sites were randomized to 1 of 3 tracks, which determined the timing of intervention: Track A: audit at week 40, MCI at week 68 Track B: audit at week 44, MCI at week 74 Track C: audit at week 53, MCI at week 81]: We will assess the change in the percentage 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.
• Change in Mean Organ Doses: Brain Dose for Head CT; Lung Dose For Chest CT; Colon and Liver Dose for Abdomen CT [Sites were randomized to 1 of 3 tracks, which determined the timing of intervention: Track A: audit at week 40, MCI at week 68 Track B: audit at week 44, MCI at week 74 Track C: audit at week 53, MCI at week 81]: We will assess the change in organ doses after the simple audit and multi-component interventions (MCI) in comparison to before the audit and multi-component interventions. The numbers given below reflect absolute change in mean dose (in millisieverts) relative to the baseline period.

Sex: All, ages: any to 99 Years, accepts healthy volunteers

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

Participant flow

Outcome results

• Change in Mean Effective Dose (ED) (Primary), Mean, Millisieverts (mSv): Simple Audit Intervention Period -0.13 (-0.24 to -0.02); Multi-component Intervention Period -0.81 (-0.99 to -0.64)
• Percentage of CT Scans With an Effective Dose Above Benchmark (Primary), Number, Percent of CT scans over benchmark: Baseline Period 24.7; Simple Audit Intervention Period 24.7; Multi-component Intervention Period 22.2
• Mean Dose Length Product (Secondary)
• Proportion of CT Scans With a Dose Length Product Above Benchmark (Secondary)
• Change in Mean Volume Computed Tomography Dose Index (CTDIvol) (Secondary), Mean, Milligrays (mGy): Simple Audit Intervention Period 0.09 (0.01 to 0.16); Multi-component Intervention Period 0.03 (-0.10 to 0.15)
• Percentage of CT Scans With a CTDIvol Above Benchmark (Secondary), Number, Percentage of CT scans: Baseline Period 24.5; Simple Audit Intervention Period 24.9; Multi-component Intervention Period 24.1
• Change in Mean Organ Doses: Brain Dose for Head CT; Lung Dose For Chest CT; Colon and Liver Dose for Abdomen CT (Secondary), Mean, Milligrays (mGy): Simple Audit Intervention Period -6.0 (-6.9 to -5.0); Multi-component Intervention Period -12.2 (-13.8 to -10.6)

Adverse events

Time frame: Adverse events were not collected.

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• Results publication: 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. PMID 32227142
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• Study Protocol and Statistical Analysis Plan (PDF, 2017-08-29)

• Rebecca Smith-Bindman, MD, Principal investigator, University of California, San Francisco
• Judy Yee, MD, Principal investigator, San Francisco Veterans Administration
• Tom Nelson, PhD, Principal investigator, University of California, San Diego
• Tony Seibert, PhD, Principal investigator, University of California, Davis
• Mayil Krishnam, MD, Principal investigator, University of California, Irvine
• Michael Flynn, PhD, Principal investigator, Henry Ford Health System
• Mary Cocker, MSc, Csci, Principal investigator, Oxford University Hospitals NHS Trust
• William Boswell, MD, Principal investigator, City of Hope Medical Center
• Sebastian Schindera, MD, Principal investigator, University Hospital of Basel
• Erin Bell, MHP, Principal investigator, Community Health Network
• Phuong-Anh Duong, MD, Principal investigator, Emory University
• Nima Kasraie, PhD, MSc, Principal investigator, Children's Mercy Hospital Kansas City
• Pavlina Pike, PhD, Principal investigator, Huntsville Hospital
• Luisa Cervantes, MD, Principal investigator, Nicklaus Children's Hospital f/k/a Miami Children's Hospital
• Joachim Wildberger, PhD, Principal investigator, Maastricht University Medical Center
• Michael Forsting, MD, Principal investigator, University of Duisburg-Essen
• Fady Kassem, PhD, Principal investigator, St. Joseph Hospital of Orange
• Darrell Fendrick, CT, Principal investigator, East Texas Medical Center
• Sugoto Mukherjee, MD, Principal investigator, University of Virginia Health System
• Brad Delman, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
• Jodi Roehm, Principal investigator, Center for Diagnostic Imaging
• Anokh Pahwa, MD, Principal investigator, Olive View - UCLA
• Ryan Lee, MD, MBA, Principal investigator, Einstein Medical Center
• Jay Starkey, MD, Principal investigator, St. Luke's International Hospital, Tokyo
• Diana Miglioretti, PhD, Principal investigator, University of California, Davis
• Saravanabavaan Suntharalingam, MD, Principal investigator, University of Duisburg-Essen
• Sara Lewis, MD, Principal investigator, Icahn School of Medicine at Mount Sinai

NIH grants: R01CA181191