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CT DOSE Collaboratory

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ClinicalTrials.gov Identifier: NCT03000751
Recruitment Status : Active, not recruiting
First Posted : December 22, 2016
Last Update Posted : September 5, 2017
Sponsor:
Collaborators:
University of California, Davis
University Hospital, Basel, Switzerland
Center for Diagnostic Imaging
Community Health Network
Children's Mercy Hospital Kansas City
City of Hope Medical Center
Albert Einstein Healthcare Network
Universität Duisburg-Essen
East Texas Medical Center Regional Healthcare System
Emory University
Henry Ford Health System
Huntsville Hospital Health System
Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Mount Sinai Hospital, New York
Maastricht University Medical Center
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 of Virginia
University of California, Irvine
University of California, San Diego
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Rebecca Smith-Bindman, 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.


Condition or disease Intervention/treatment Phase
Ionizing Radiation Exposure Quality Improvement Other: Simple Audit Report Other: Multi-Component Intervention Other: In-Person Meeting Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200000 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: CT Dose Optimization and Standardization Endeavor (DOSE) Collaboratory
Study Start Date : September 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

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



Primary Outcome Measures :
  1. Mean Effective Dose (ED) [ Time Frame: 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). ]
    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.

  2. Proportion of CT scans with an Effective dose above benchmarks [ Time Frame: 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). ]
    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.


Secondary Outcome Measures :
  1. Mean Dose length product [ Time Frame: 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). ]
    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: 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). ]
    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. Mean CTDIvol [ Time Frame: 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). ]
    We will assess the change in the CTDIvol after the audit and MCI in comparison to before the audit and multicomponent intervention.

  4. Proportion of CT scans with a CTDIvol above benchmark [ Time Frame: 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). ]
    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.

  5. Mean Effective dose [ Time Frame: 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). ]
    We will assess the delayed effects of the intervention on mean effective dose.

  6. Proportion of examinations with an Effective dose above the benchmark [ Time Frame: 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). ]
    We will assess the delayed effects of the intervention on the proportion of examinations with an effective dose above the benchmark.

  7. Mean Dose Length Product [ Time Frame: 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). ]
    We will assess the delayed effects of the intervention on mean Dose Length Product.

  8. Proportion of examinations with a Dose Length Product above the benchmark [ Time Frame: 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). ]
    We will assess the delayed effects of the intervention on the proportion of examinations with a Dose Length Product above the benchmark.

  9. Mean CTDIvol [ Time Frame: 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). ]
    We will assess the delayed effects of the intervention on mean effective dose.

  10. Proportion of examinations with a CTDIvol above the benchmark [ Time Frame: 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). ]
    We will assess the delayed effects of the intervention on the proportion of examinations with a CTDIvol above the benchmark.

  11. Mean Effective Dose [ Time Frame: 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 ]
    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.

  12. Proportion of examinations with an effective dose above the benchmark [ Time Frame: 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 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 99 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03000751


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

Documents provided by Rebecca Smith-Bindman, University of California, San Francisco:

Additional Information:
Publications:
Conference of Radiation Control Program Directors. Nationwide evaluation of x-ray trends (NEXT): Tabulation and graphical summary of 2000 survey of computed tomography . Frankfort, KY2007.
Medicare Payment Advisory Commission. A Data Book: Healthcare Spending and the Medicare Program, June 2010.
National Council on Radiation Protection and Measurements. NCRP Report No. 93, Ionizing Radiation Exposure of the Population of the United States. 1987
National Council on Radiation Protection and Measurements. NCRP Report No 160, Ionizing Radiation Exposure of the Population of the United States, press release available , full report soon to be released; 2009
Board of Radiation Effects Research Division on Earth and Life Sciences National Research Council of the National Academies. Health Risks from Exposure to Low Levels of Ionizing Radiation: BEIR VII Phase 2 Washington, D.C.: The National Academies Press; 2006.
Hertz-Picciotto I. Breast Cancer and the Environment: A Life Course Approach. Dec 2011 2011.
Radiation protection 118 : referral guidelines for imaging. Luxembourg European Commission, Directorate- General for the Environment; 2001
U.S. Food and Drug Administration. FDA White Paper: Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging. 2010; http://www.fda.gov/Radiation- EmittingProducts/RadiationSafety/RadiationDoseReduction/ucm199994.htm.
US Food and Drug Administration. Safety Investigation of CT Brain Perfusion Scans: Update 11/9/2010. 2009
Bogdanich W. After stroke scans, patients face serious risk. New York TImes. July 31, 2010, 2010.
Bogdanich W. Listing of articles published in the NY TImes over the last year in the 'Radiation Boom' series by Walt Bogdanich examine issues arising from the increasing use of medical radiation and the new technologies that deliver it. . http://topics.nytimes.com/top/news/us/series/radiation_boom/index.html?ref=health.
The US House of Representatives, Energy and Commerce Committee, Subcommittee on Health held a hearing entitled
UK National Health Program Department of Health. The Ionising Radiation (Medical Exposure) Regulations 2000 (together with notes on good practice). 2007, http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4007957, accessed January 15, 2011
Center for Medicare and Medicaid Services. Section 135(b)of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) mandates an Appropriate Use of Imaging Services demonstration project. The goal of the demonstration is to collect data regarding physician use of advanced diagnostic imaging services to determine the appropriateness of services in relation to established criteria and physician peers. 2010; http://www.cms.gov/demoprojectsevalrpts/md/itemdetail.asp?itemid=CMS1222075.
The Joint Commission Sentinel Event Alert System. 2011; http://www.jointcommission.org/assets/1/18/SEA_471.PDF.
Image Gently. 2009. http://www.pedrad.org/associations/5364/ig/index.cfm?page=369. Accessed Feb 13, 2009.
Aarons G, Horowitz J, Dlugosz L, Ehrhart M. The role of organizational processes in dissemination and implementation researach. In: Brownson RC, Colditz GA, Proctor EK, eds. Dissemination and Implementation Research in Health: Translating Science to Practice. New York: Oxford University Press, Inc.; 2012:
Schueler K, Chu P, Smith-Bindman R. "Racial Differences in the Use of Mammography:" A Meta-analytical Review of Literature Describing Economic, Social, and Cultural Reasons for Variation in Use of Mammography". Submitted. 2005
Solberg L. Quality improvement in primary care: The role of organization, systems, and collaboratives. In: Sollecito WA, Johnson JK, eds. McLaughlin and Kaluzny's continuous quality improvement in health care. Fourth ed. Burlington, MA: Jones & Bartlett Learning; 399-419. 2011
American Association of Physicists in Medicine Position Statement on Radiation Risks from Medical Imaging Procedures. 2011
American Association of Physicists in Medicine. AAPM Report No 96. The Measurement, reporting and management of radiation dose in CT, Report of AAPM Task group 23 of the Diagnostic Imaging Council CT Committee. College Park, MD: American Association of Physicists in Medicine; 2008
NQF. National Quality Forum Measure 0739, Radiation Dose of Computed Tomography (CT) Steward: University of California San Francisco. 2011; http://www.qualityforum.org/QPS/0739
Mittman B. Implementation Science in Health Care. In: Brownson RC, Colditz GA, Proctor EK, eds. Dissemination and Implementation Research in Health. New York: Oxford University Press; 2012:400-418
Marshall C, & Rossman, G.B. Designing Qualitative Research. 4th ed. Newbury Park: Sage Publications; 2006.
Huberman MM. Qualitative Data Analysis: An Expanded Sourcebook. Thousand Oaks, CA: Sage Publications; 1994.
Patton MQ. Qualitative Research and Evaluation Methods. 3rd ed. Newbury Park: Sage Publications; 2002.
Padgett D. Qualitative Methods in Social Work Research: Challenges and Rewards. Thousand Oaks, CA: Sage; 1998
Seale C. The Quality of Qualitative Research. Thousand Oaks: Sage Publications; 1999
171. Morgan KL, Rubin, D.L. Rerandomization to improve covariate balance in experiments. The Annals of Statistics 2012;40:1263-82.

Responsible Party: Rebecca Smith-Bindman, Professor in Residence, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03000751     History of Changes
Other Study ID Numbers: RSB-181191
R01CA181191 ( U.S. NIH Grant/Contract )
First Posted: December 22, 2016    Key Record Dates
Last Update Posted: September 5, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Rebecca Smith-Bindman, University of California, San Francisco:
CT scan
CT exam
ionizing radiation
medical imaging
cat scan
radiation