NCT03000751

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
864,080

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 22, 2016

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

March 8, 2024

Completed
Last Updated

March 8, 2024

Status Verified

March 1, 2024

Enrollment Period

4.4 years

First QC Date

December 12, 2016

Results QC Date

December 24, 2021

Last Update Submit

March 5, 2024

Conditions

Ionizing Radiation ExposureQuality Improvement

Keywords

CT scanCT examionizing radiationmedical imagingcat scanradiation

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (3)

Track A

ACTIVE COMPARATOR

Simple Audit Report; In-Person Meeting (timed to coincide with the multi-component intervention); Multi-Component Intervention

Other: Simple Audit ReportOther: Multi-Component InterventionOther: In-Person Meeting

Track B

ACTIVE COMPARATOR

In-Person Meeting (timed to coincide with the simple audit report); Simple Audit Report; Multi-Component Intervention

Other: Simple Audit ReportOther: Multi-Component InterventionOther: In-Person Meeting

Track C

OTHER

Simple Audit Report; Multi-Component Intervention

Other: Simple Audit ReportOther: Multi-Component Intervention

Interventions

Simple Audit ReportOTHER

The simple audit provides comparison and feedback on radiation doses.

Track ATrack BTrack C
Multi-Component InterventionOTHER

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).

Track ATrack BTrack C
In-Person MeetingOTHER

Collaborator meeting with an emphasis on quality improvement.

Track ATrack B

Eligibility Criteria

AgeUp to 99 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (160)

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  • Shojania KG, Ranji SR, McDonald KM, Grimshaw JM, Sundaram V, Rushakoff RJ, Owens DK. Effects of quality improvement strategies for type 2 diabetes on glycemic control: a meta-regression analysis. JAMA. 2006 Jul 26;296(4):427-40. doi: 10.1001/jama.296.4.427.

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    PMID: 22552990BACKGROUND

  • 171. Morgan KL, Rubin, D.L. Rerandomization to improve covariate balance in experiments. The Annals of Statistics 2012;40:1263-82.

    BACKGROUND

  • Smith-Bindman R, Chu P, Wang Y, Chung R, Lopez-Solano N, Einstein AJ, Solberg L, Cervantes LF, Yellen-Nelson T, Boswell W, Delman BN, Duong PA, Goode AR, Kasraie N, Lee RK, Neill R, Pahwa A, Pike P, Roehm J, Schindera S, Starkey J, Suntharalingam S, Jeukens CRLPN, Miglioretti DL. Comparison of the Effectiveness of Single-Component and Multicomponent Interventions for Reducing Radiation Doses in Patients Undergoing Computed Tomography: A Randomized Clinical Trial. JAMA Intern Med. 2020 May 1;180(5):666-675. doi: 10.1001/jamainternmed.2020.0064.

    PMID: 32227142RESULT

  • Smith-Bindman R, Wang Y, Chu P, Chung R, Einstein AJ, Balcombe J, Cocker M, Das M, Delman BN, Flynn M, Gould R, Lee RK, Nelson TR, Schindera S, Seibert A, Starkey J, Suntharalingam S, Wetter A, Wildberger JE, Miglioretti DL. International variation in radiation dose for computed tomography examinations: prospective cohort study. BMJ. 2019 Jan 2;364:k4931. doi: 10.1136/bmj.k4931.

    PMID: 30602590DERIVED

Related Links

Results Point of Contact

Title
Rebecca Smith-Bindman, MD
Organization
University of California San Francisco
rebecca.smith-bindman@ucsf.edu
415-353-4946

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2016

First Posted

December 22, 2016

Study Start

July 1, 2016

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

March 8, 2024

Results First Posted

March 8, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share