CT DOSE Collaboratory

Not Applicable

Completed

• Conditions: Quality Improvement; Ionizing Radiation Exposure
• Interventions: Other: Simple Audit Report; Other: Multi-Component Intervention; Other: In-Person Meeting

• Registration Number: NCT03000751
• Lead Sponsor: University of California, San Francisco

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.

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 Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-12-12
• Study First Submitted QC: 2016-12-19
• Study First Posted: 2016-12-22
• Primary Completion: 2020-12
• Study Completion: 2020-12
• Results First Submitted: 2021-12-24
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-05
• Last Update Submitted: 2024-03-05
• Results First Posted: 2024-03-08
• Last Update Posted: 2024-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 864080

Inclusion Criteria

• Diagnostic CT scans of the head, chest, and/or abdomen/pelvis performed within the study period

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Exclusion Criteria

• non-diagnostic scans that are not of the head, chest, and/or abdomen/pelvis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Track B	In-Person Meeting	In-Person Meeting (timed to coincide with the simple audit report); Simple Audit Report; Multi-Component Intervention
Track A	Simple Audit Report	Simple Audit Report; In-Person Meeting (timed to coincide with the multi-component intervention); Multi-Component Intervention
Track A	In-Person Meeting	Simple Audit Report; In-Person Meeting (timed to coincide with the multi-component intervention); Multi-Component Intervention
Track B	Multi-Component Intervention	In-Person Meeting (timed to coincide with the simple audit report); Simple Audit Report; Multi-Component Intervention
Track B	Simple Audit Report	In-Person Meeting (timed to coincide with the simple audit report); Simple Audit Report; Multi-Component Intervention
Track C	Simple Audit Report	Simple Audit Report; Multi-Component Intervention
Track C	Multi-Component Intervention	Simple Audit Report; Multi-Component Intervention
Track A	Multi-Component Intervention	Simple Audit Report; In-Person Meeting (timed to coincide with the multi-component intervention); Multi-Component Intervention

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.