CT DOSE Collaboratory

March 5, 2024 updated by: University of California, San Francisco

CT Dose Optimization and Standardization Endeavor (DOSE) Collaboratory

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

864080

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Track A
Simple Audit Report; In-Person Meeting (timed to coincide with the multi-component intervention); 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 (timed to coincide with the simple audit report); 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.
Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Mean Effective Dose (ED)
Time Frame: 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.
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
Percentage of CT Scans With an Effective Dose Above Benchmark
Time Frame: 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.
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Dose Length Product
Time Frame: 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.
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
Proportion of CT Scans With a Dose Length Product Above Benchmark
Time Frame: 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.
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
Change in Mean Volume Computed Tomography Dose Index (CTDIvol)
Time Frame: 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.
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
Percentage of CT Scans With a CTDIvol Above Benchmark
Time Frame: 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.
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
Change in Mean Organ Doses: Brain Dose for Head CT; Lung Dose For Chest CT; Colon and Liver Dose for Abdomen CT
Time Frame: 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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Albert Einstein Healthcare Network
National Cancer Institute (NCI)
University of California, San Diego
City of Hope Medical Center
Maastricht University Medical Center
Emory University
University of California, Davis
University Hospital, Basel, Switzerland
University of California, Irvine
Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Henry Ford Health System
University of Virginia
Children's Mercy Hospital Kansas City
Universität Duisburg-Essen
Mount Sinai Hospital, New York
Oxford University Hospitals NHS Trust
St. Joseph Hospital of Orange
Olive View-UCLA Education & Research Institute
San Francisco VA Health Care System
Center for Diagnostic Imaging
Community Health Network
East Texas Medical Center Regional Healthcare System
Huntsville Hospital Health System
St. Luke's International Hospital, Japan

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 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

December 12, 2016

First Submitted That Met QC Criteria

December 19, 2016

First Posted (Estimated)

December 22, 2016

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RSB-181191
  • R01CA181191 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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