CT DOSE Collaboratory

Quality Improvement Clinical Trial

Official title:

CT Dose Optimization and Standardization Endeavor (DOSE) Collaboratory

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03000751
• Other study ID #: RSB-181191
• Secondary ID: R01CA181191
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: December 2020

Study information

• Verified date: March 2024
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 864080
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Ionizing Radiation Exposure
• Quality Improvement

Intervention

Other:
• Simple Audit Report
The simple audit provides comparison and feedback on radiation doses.
• 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).
• In-Person Meeting
Collaborator meeting with an emphasis on quality improvement.

Locations

Country	Name	City	State
n/a

Sponsors (25)

Lead Sponsor

Collaborator

University of California, San Francisco

Albert Einstein Healthcare Network, Center for Diagnostic Imaging, Children's Mercy Hospital Kansas City, City of Hope Medical Center, Community Health Network, East Texas Medical Center Regional Healthcare System, Emory University, Henry Ford Health System, Huntsville Hospital Health System, Maastricht University Medical Center, Mount Sinai Hospital, New York, National Cancer Institute (NCI), Nicklaus Children's Hospital f/k/a Miami Children's Hospital, 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, Universität Duisburg-Essen, University Hospital, Basel, Switzerland, University of California, Davis, University of California, Irvine, University of California, San Diego, University of Virginia

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* Note: There are 159 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Mean Effective Dose (ED)	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
Primary	Percentage of CT Scans With an Effective Dose Above Benchmark	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	Mean Dose Length Product	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
Secondary	Proportion of CT Scans With a Dose Length Product Above Benchmark	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
Secondary	Change in Mean Volume Computed Tomography Dose Index (CTDIvol)	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
Secondary	Percentage of CT Scans With a CTDIvol Above Benchmark	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
Secondary	Change in Mean Organ Doses: Brain Dose for Head CT; Lung Dose For Chest CT; Colon and Liver Dose for Abdomen CT	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

External Links

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