CT DOSE Collaboratory

Study Overview
=================
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.

Official Title
-----------------
CT Dose Optimization and Standardization Endeavor (DOSE) Collaboratory

Conditions
-----------------
Ionizing Radiation Exposure, Quality Improvement

Intervention / Treatment
-----------------
* Other: Simple Audit Report
* Other: Multi-Component Intervention
* Other: In-Person Meeting


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Track A<br>Simple Audit Report In-Person Meeting Multi-Component Intervention | Other: Simple Audit Report<br>* The simple audit provides comparison and feedback on radiation doses.<br>Other: Multi-Component Intervention<br>* 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).<br>Other: In-Person Meeting<br>* Collaborator meeting with an emphasis on quality improvement.<br>|
| Active Comparator: Track B<br>In-Person Meeting Simple Audit Report Multi-Component Intervention | Other: Simple Audit Report<br>* The simple audit provides comparison and feedback on radiation doses.<br>Other: Multi-Component Intervention<br>* 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).<br>Other: In-Person Meeting<br>* Collaborator meeting with an emphasis on quality improvement.<br>|
| Other: Track C<br>Simple Audit Report Multi-Component Intervention | Other: Simple Audit Report<br>* The simple audit provides comparison and feedback on radiation doses.<br>Other: Multi-Component Intervention<br>* 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).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Effective Dose (ED) | 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. | 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). | 
| Proportion of CT scans with an Effective dose above benchmarks | 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. | 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). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 
| 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. | 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). | 
| Mean CTDIvol | We will assess the change in the CTDIvol after the audit and MCI in comparison to before the audit and multicomponent intervention. | 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). | 
| Proportion of CT scans with a CTDIvol above benchmark | 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. | 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). | 
| Mean Effective dose | We will assess the delayed effects of the intervention on mean effective dose. | 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). | 
| Proportion of examinations with an Effective dose above the benchmark | We will assess the delayed effects of the intervention on the proportion of examinations with an effective dose above the benchmark. | 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). | 
| Mean Dose Length Product | We will assess the delayed effects of the intervention on mean Dose Length Product. | 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). | 
| Proportion of examinations with a Dose Length Product above the benchmark | We will assess the delayed effects of the intervention on the proportion of examinations with a Dose Length Product above the benchmark. | 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). | 
| Mean CTDIvol | We will assess the delayed effects of the intervention on mean effective dose. | 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). | 
| Proportion of examinations with a CTDIvol above the benchmark | We will assess the delayed effects of the intervention on the proportion of examinations with a CTDIvol above the benchmark. | 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). | 
| Mean Effective Dose | 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. | 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 | 
| Proportion of examinations with an effective dose above the benchmark | 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. | 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 | 
| Organ Doses: Brain Dose for Head CT; Lung Dose For Chest CT; Colon and Liver Dose for Abdomen CT | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CT scan, CT exam, ionizing radiation, medical imaging, cat scan, radiation