Ionizing Radiation ExposureNCT03000751
CT DOSE Collaboratory
A study testing Simple Audit Report, Multi-Component Intervention and In-Person Meeting in people with Ionizing Radiation Exposure and Quality Improvement, run by University of California, San Francisco.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Ionizing Radiation Exposure, Quality Improvement
- What is being tested?
- Simple Audit Report, Multi-Component Intervention and In-Person Meeting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 864,080 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Diagnostic CT scans of the head, chest, and/or abdomen/pelvis performed within the study period
Who cannot join
- non-diagnostic scans that are not of the head, chest, and/or abdomen/pelvis
About this study
Official title: CT Dose Optimization and Standardization Endeavor (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.
Read the 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.
- Conditions
- Ionizing Radiation Exposure, Quality Improvement
- Being tested
- Simple Audit Report, Multi-Component Intervention, In-Person Meeting
- Keywords
- CT scan, CT exam, ionizing radiation, medical imaging, cat scan, radiation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simple Audit ReportOther
The simple audit provides comparison and feedback on radiation doses.
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).
In-Person MeetingOther
Collaborator meeting with an emphasis on quality improvement.
| Study group | Role | What they receive |
|---|---|---|
| Track A | Active comparator | Simple Audit Report; In-Person Meeting (timed to coincide with the multi-component intervention); Multi-Component Intervention Receives: Other: Simple Audit Report; Other: Multi-Component Intervention; Other: In-Person Meeting |
| Track B | Active comparator | In-Person Meeting (timed to coincide with the simple audit report); Simple Audit Report; Multi-Component Intervention Receives: Other: Simple Audit Report; Other: Multi-Component Intervention; Other: In-Person Meeting |
| Track C | Other | Simple Audit Report; Multi-Component Intervention Receives: Other: Simple Audit Report; Other: Multi-Component Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
We will assess the change in the dose length product after the audit and MCI in comparison to before the audit and MCI.
Measured: 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
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.
Measured: 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)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (160)Papers the sponsor has linked to this study.
- Other trials for Ionizing Radiation ExposureStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 864,080 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- 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)
- Responsible party
- Sponsor
- Investigators
- Rebecca Smith-Bindman, MD, Principal investigator, University of California, San FranciscoJudy Yee, MD, Principal investigator, San Francisco Veterans AdministrationTom Nelson, PhD, Principal investigator, University of California, San DiegoTony Seibert, PhD, Principal investigator, University of California, DavisMayil Krishnam, MD, Principal investigator, University of California, IrvineMichael Flynn, PhD, Principal investigator, Henry Ford Health SystemMary Cocker, MSc, Csci, Principal investigator, Oxford University Hospitals NHS TrustWilliam Boswell, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03000751
- Sponsor's protocol ID
- RSB-181191
- Other IDs
- R01CA181191
- Status last verified
- Mar 2024
- First submitted
- 12 Dec 2016
- Last updated
- 8 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Solberg LI. Improving medical practice: a conceptual framework. Ann Fam Med. 2007 May-Jun;5(3):251-6. doi: 10.1370/afm.666.
PubMed 17548853Solberg LI, Asche SE, Margolis KL, Whitebird RR. Measuring an organization's ability to manage change: the change process capability questionnaire and its use for improving depression care. Am J Med Qual. 2008 May-Jun;23(3):193-200. doi: 10.1177/1062860608314942.
PubMed 18539980Schindera ST, Treier R, von Allmen G, Nauer C, Trueb PR, Vock P, Szucs-Farkas Z. An education and training programme for radiological institutes: impact on the reduction of the CT radiation dose. Eur Radiol. 2011 Oct;21(10):2039-45. doi: 10.1007/s00330-011-2168-5. Epub 2011 May 31.
PubMed 21626359Keegan J, Miglioretti DL, Gould R, Donnelly LF, Wilson ND, Smith-Bindman R. Radiation dose metrics in CT: assessing dose using the National Quality Forum CT patient safety measure. J Am Coll Radiol. 2014 Mar;11(3):309-15. doi: 10.1016/j.jacr.2013.10.009.
PubMed 24589407Miglioretti DL, Zhang Y, Johnson E, Lee C, Morin RL, Vanneman N, Smith-Bindman R. Personalized technologist dose audit feedback for reducing patient radiation exposure from CT. J Am Coll Radiol. 2014 Mar;11(3):300-8. doi: 10.1016/j.jacr.2013.10.017.
PubMed 24589406Pearce MS, Salotti JA, Little MP, McHugh K, Lee C, Kim KP, Howe NL, Ronckers CM, Rajaraman P, Sir Craft AW, Parker L, Berrington de Gonzalez A. Radiation exposure from CT scans in childhood and subsequent risk of leukaemia and brain tumours: a retrospective cohort study. Lancet. 2012 Aug 4;380(9840):499-505. doi: 10.1016/S0140-6736(12)60815-0. Epub 2012 Jun 7.
PubMed 22681860Mathews JD, Forsythe AV, Brady Z, Butler MW, Goergen SK, Byrnes GB, Giles GG, Wallace AB, Anderson PR, Guiver TA, McGale P, Cain TM, Dowty JG, Bickerstaffe AC, Darby SC. Cancer risk in 680,000 people exposed to computed tomography scans in childhood or adolescence: data linkage study of 11 million Australians. BMJ. 2013 May 21;346:f2360. doi: 10.1136/bmj.f2360.
PubMed 23694687Conference of Radiation Control Program Directors. Nationwide evaluation of x-ray trends (NEXT): Tabulation and graphical summary of 2000 survey of computed tomography . Frankfort, KY2007.
Bhargavan M, Sunshine JH. Utilization of radiology services in the United States: levels and trends in modalities, regions, and populations. Radiology. 2005 Mar;234(3):824-32. doi: 10.1148/radiol.2343031536. Epub 2005 Jan 28.
PubMed 15681686Smith-Bindman R, Miglioretti DL, Larson EB. Rising use of diagnostic medical imaging in a large integrated health system. Health Aff (Millwood). 2008 Nov-Dec;27(6):1491-502. doi: 10.1377/hlthaff.27.6.1491.
PubMed 18997204Baker LC, Atlas SW, Afendulis CC. Expanded use of imaging technology and the challenge of measuring value. Health Aff (Millwood). 2008 Nov-Dec;27(6):1467-78. doi: 10.1377/hlthaff.27.6.1467.
PubMed 18997202Medicare Payment Advisory Commission. A Data Book: Healthcare Spending and the Medicare Program, June 2010.
Levin DC, Rao VM, Parker L, Frangos AJ, Sunshine JH. Bending the curve: the recent marked slowdown in growth of noninvasive diagnostic imaging. AJR Am J Roentgenol. 2011 Jan;196(1):W25-9. doi: 10.2214/AJR.10.4835.
PubMed 21178027Smith-Bindman R, Miglioretti DL, Johnson E, Lee C, Feigelson HS, Flynn M, Greenlee RT, Kruger RL, Hornbrook MC, Roblin D, Solberg LI, Vanneman N, Weinmann S, Williams AE. Use of diagnostic imaging studies and associated radiation exposure for patients enrolled in large integrated health care systems, 1996-2010. JAMA. 2012 Jun 13;307(22):2400-9. doi: 10.1001/jama.2012.5960.
PubMed 22692172Mettler FA Jr, Huda W, Yoshizumi TT, Mahesh M. Effective doses in radiology and diagnostic nuclear medicine: a catalog. Radiology. 2008 Jul;248(1):254-63. doi: 10.1148/radiol.2481071451.
PubMed 18566177
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT Dose Optimization and Standardization Endeavor (DOSE) Collaboratory
- ClinicalTrials.gov ID
- NCT03000751
- Acronym / sponsor ID
- RSB-181191
- Conditions
- Ionizing Radiation Exposure, Quality Improvement
- Keywords
- CT scan, CT exam, ionizing radiation, medical imaging, cat scan, radiation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 864,080 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- 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)
- Study start
- Jul 2016 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 22 Dec 2016 (estimated)
- Results
- Posted 8 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Track A | Active comparator | Other: Simple Audit Report, Other: Multi-Component Intervention, Other: In-Person MeetingSimple Audit Report; In-Person Meeting (timed to coincide with the multi-component intervention); Multi-Component Intervention |
| Track B | Active comparator | Other: Simple Audit Report, Other: Multi-Component Intervention, Other: In-Person MeetingIn-Person Meeting (timed to coincide with the simple audit report); Simple Audit Report; Multi-Component Intervention |
| Track C | Other | Other: Simple Audit Report, Other: Multi-Component InterventionSimple Audit Report; Multi-Component Intervention |
Who may qualify
- Ages
- Up to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnostic CT scans of the head, chest, and/or abdomen/pelvis performed within the study period
Key exclusion criteria (1 listed)
- non-diagnostic scans that are not of the head, chest, and/or abdomen/pelvis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simple Audit ReportThe simple audit provides comparison and feedback on radiation doses. | Other | Track A, Track B, Track C |
| Multi-Component InterventionThe 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 | Track A, Track B, Track C |
| In-Person MeetingCollaborator meeting with an emphasis on quality improvement. | Other | Track A, Track B |
Primary outcome
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.
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.
5 secondary outcomes
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
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
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17548853Solberg LI. Improving medical practice: a conceptual framework. Ann Fam Med. 2007 May-Jun;5(3):251-6. doi: 10.1370/afm.666.
- Background: PubMed 18539980Solberg LI, Asche SE, Margolis KL, Whitebird RR. Measuring an organization's ability to manage change: the change process capability questionnaire and its use for improving depression care. Am J Med Qual. 2008 May-Jun;23(3):193-200. doi: 10.1177/1062860608314942.
- Background: PubMed 21626359Schindera ST, Treier R, von Allmen G, Nauer C, Trueb PR, Vock P, Szucs-Farkas Z. An education and training programme for radiological institutes: impact on the reduction of the CT radiation dose. Eur Radiol. 2011 Oct;21(10):2039-45. doi: 10.1007/s00330-011-2168-5. Epub 2011 May 31.
- Background: PubMed 24589407Keegan J, Miglioretti DL, Gould R, Donnelly LF, Wilson ND, Smith-Bindman R. Radiation dose metrics in CT: assessing dose using the National Quality Forum CT patient safety measure. J Am Coll Radiol. 2014 Mar;11(3):309-15. doi: 10.1016/j.jacr.2013.10.009.
- Background: PubMed 24589406Miglioretti DL, Zhang Y, Johnson E, Lee C, Morin RL, Vanneman N, Smith-Bindman R. Personalized technologist dose audit feedback for reducing patient radiation exposure from CT. J Am Coll Radiol. 2014 Mar;11(3):300-8. doi: 10.1016/j.jacr.2013.10.017.
- Background: PubMed 22681860Pearce MS, Salotti JA, Little MP, McHugh K, Lee C, Kim KP, Howe NL, Ronckers CM, Rajaraman P, Sir Craft AW, Parker L, Berrington de Gonzalez A. Radiation exposure from CT scans in childhood and subsequent risk of leukaemia and brain tumours: a retrospective cohort study. Lancet. 2012 Aug 4;380(9840):499-505. doi: 10.1016/S0140-6736(12)60815-0. Epub 2012 Jun 7.
- Background: PubMed 23694687Mathews JD, Forsythe AV, Brady Z, Butler MW, Goergen SK, Byrnes GB, Giles GG, Wallace AB, Anderson PR, Guiver TA, McGale P, Cain TM, Dowty JG, Bickerstaffe AC, Darby SC. Cancer risk in 680,000 people exposed to computed tomography scans in childhood or adolescence: data linkage study of 11 million Australians. BMJ. 2013 May 21;346:f2360. doi: 10.1136/bmj.f2360.
- BackgroundConference of Radiation Control Program Directors. Nationwide evaluation of x-ray trends (NEXT): Tabulation and graphical summary of 2000 survey of computed tomography . Frankfort, KY2007.
- Background: PubMed 15681686Bhargavan M, Sunshine JH. Utilization of radiology services in the United States: levels and trends in modalities, regions, and populations. Radiology. 2005 Mar;234(3):824-32. doi: 10.1148/radiol.2343031536. Epub 2005 Jan 28.
- Background: PubMed 18997204Smith-Bindman R, Miglioretti DL, Larson EB. Rising use of diagnostic medical imaging in a large integrated health system. Health Aff (Millwood). 2008 Nov-Dec;27(6):1491-502. doi: 10.1377/hlthaff.27.6.1491.
- Background: PubMed 18997202Baker LC, Atlas SW, Afendulis CC. Expanded use of imaging technology and the challenge of measuring value. Health Aff (Millwood). 2008 Nov-Dec;27(6):1467-78. doi: 10.1377/hlthaff.27.6.1467.
- BackgroundMedicare Payment Advisory Commission. A Data Book: Healthcare Spending and the Medicare Program, June 2010.
- Individual participant dataSharing planned: No
Related trials for Ionizing Radiation Exposure
Recruiting
Exoskeleton vs. Standard Lead Apron in EVAR Procedures
Radiation Exposure to Operator, Endovascular Aortic Repair
Active, not recruitingObservational study
Epidemiological Study of Korean Radiation Workers
Occupational Exposure to Radiation, Neoplasms, Radiation-Induced
Not yet recruitingObservational study
Nailfold Capillaroscopy and Endothelial Biomarkers in Healthcare Workers Exposed to Chronic Low-Dose Ionizing Radiation
Microvascular Dysfunction, Endothelial Dysfunction
Active, not recruitingObservational study
Assessment of THL and Potential Risk of Hypothyroidism in Healthcare Workers Exposed to Low-dose Ionizing Radiation
Hyperthyroidism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Smith-Bindman, MD principal investigator
University of California, San Francisco
Judy Yee, MD principal investigator
San Francisco Veterans Administration
Tom Nelson, PhD principal investigator
University of California, San Diego
Questions about this trial
What is this clinical trial studying?
A study testing Simple Audit Report, Multi-Component Intervention and In-Person Meeting in people with Ionizing Radiation Exposure and Quality Improvement, run by University of California, San Francisco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03000751, which also lists 160 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.