Skip to main content
OpenTrials
Completed

NCT Number: NCT03000751

CT 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ionizing Radiation Exposure Quality Improvement

Age range

Up to 99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • 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
  • University Hospital, Basel, Switzerland
  • University of California, Davis
  • University of California, Irvine
  • University of California, San Diego
  • University of Virginia
  • Universität Duisburg-Essen

Registry information

Official study title

CT Dose Optimization and Standardization Endeavor (DOSE) Collaboratory

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Dec 22, 2016
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.