Decrease Variability and Amount of Radiation Dose From CT ExamsNCT01405066
Radiation Dose Audit Reports to Reduce Radiation Exposure From CT Exams
A study testing Radiation Dose Audit Reports and Educational Seminar: Radiation Dose Reduction in people with Decrease Variability and Amount of Radiation Dose From CT Exams, run by Kaiser Permanente.
Trial summary
The purpose of this study is to quantify variation in radiation dose levels across CT technologists, and determine the effectiveness of combining radiation dose audit reports and an educational seminar as a means to reduce the variation and level of patient exposure to radiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Decrease Variability and Amount of Radiation Dose From CT Exams
- What is being tested?
- Radiation Dose Audit Reports and Educational Seminar: Radiation Dose Reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- Nov 2010to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Group Health CT Technologist from Capitol Hill, Tacoma and Bellevue Clinics
Who cannot join
- None
About this study
Official title: CT Technologists Dose Audit Reports and Educational Seminar to Reduce Patient Radiation Exposure From Medical Imaging
The purpose of this study is to quantify variation in radiation dose levels across CT technologists, and determine the effectiveness of combining radiation dose audit reports and an educational seminar as a means to reduce the variation and level of patient exposure to radiation.
The investigators expect the radiation dose audit reports and educational seminar will lead to reduced radiation exposure to patients by making technologists more aware of the risks of radiation exposure from CT exams and identifying technologists with higher radiation exams compared with their peers.
The investigators expect the degree to which a technologist is concerned and aware about radiation exposure and cancer risk will be associated with adherence to radiation reduction protocols and the subsequent level of radiation their patients are exposed to when receiving a CT examination.
Read the detailed description
The use of advanced diagnostic imaging has increased dramatically over the past decade, not only contributing to rising medical costs but also exposure to ionizing radiation, of which CT imaging plays a prominent role because it requires a relatively high dose of radiation to produce an image when compared to conventional X-rays. The growth in the use of CT imaging along with all other advanced medical imaging has been well documented, and taken as a whole the use of these services has grown quicker than all other services provided by physicians. Research has also shown great variability in the amount of radiation exposure to individual patients, even when patient and other characteristics are controlled for. Given the increase in the use of CT imaging and the variability in radiation exposure between similar imaging exams, it is important to study ways of standardizing and reducing radiation levels from CT imaging. Little is understood about the role of CT technologists' attitudes and how they may influence patient radiation exposure, therefore, this project also give us the opportunity to survey the technologists and determine if there is a relationship between technologist attitudes and awareness and the radiation exposure of patients.
- Being tested
- Radiation Dose Audit Reports, Educational Seminar: Radiation Dose Reduction
- Keywords
- Computed Tomography (CT), Ionizing radiation, Advanced medical imaging, Radiation Dose Audit Reports
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation Dose Audit ReportsBehavioural
Audit reports by CT technologist, with graphs of radiation dose levels of 20 exams from each of the 4 most common CT exams. Reports show the distribution of radiation dose levels by each exam type, and compares the technologist's dose levels to the overall levels from the clinic where they work and to the United Kingdom's 2003 Reference Dose. Prior to the graphs, the reports include an introductory page explaining the organization of the report and defining the dosimetry metrics. The final page of the report lists exams meriting individual review because their doses are higher than that of the clinic averages.
Educational Seminar: Radiation Dose ReductionBehavioural
Seminar led by a Radiologic Physicist and Radiologist. Discussion of the parameters associated with radiation dosage from CT exams and methods for changing these parameters to lower radiation dose.
| Study group | Role | What they receive |
|---|---|---|
| Dose Reports and Educational Seminar | Experimental | Not described Receives: Behavioral: Radiation Dose Audit Reports; Behavioral: Educational Seminar: Radiation Dose Reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation dose levels (measured by dose linear product (DLP) and effective dose (ED)) from CT exams as a measure of the effectiveness of radiation dose audit reporting and educational intervention for lowering patient exposure to radiation from CT exams.
We will report dose data at two time points, April 2011 (data for these reports collect from November 2010 to March 2011), and September 2011 (data collected from April 2011 to August 2011), and compare the data from the two time points to see if there was a change in dose levels (DLP and ED) for the time period (April to August) after the presentation of the first audit reports and delivery of the educational interventions to the CT technologists.
Measured: April 2011 and September 2011
Secondary outcomes (1)
CT Tech technologists attitudes and awareness towards radiation exposure from CT imaging
Measured: April 2011 to September 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2011 (estimated)
- Study startNov 2010
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decrease Variability and Amount of Radiation Dose From CT ExamsStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Diana Miglioretti, PhD, Principal investigator, Group Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01405066
- Sponsor's protocol ID
- GroupHealthCoop Foundation2011
- Status last verified
- Feb 2022
- First submitted
- 21 Jul 2011
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT Technologists Dose Audit Reports and Educational Seminar to Reduce Patient Radiation Exposure From Medical Imaging
- ClinicalTrials.gov ID
- NCT01405066
- Acronym / sponsor ID
- GroupHealthCoop Foundation2011
- Keywords
- Computed Tomography (CT), Ionizing radiation, Advanced medical imaging, Radiation Dose Audit Reports
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- University of California, San Francisco
- Study start
- Nov 2010
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 29 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to quantify variation in radiation dose levels across CT technologists, and determine the effectiveness of combining radiation dose audit reports and an educational seminar as a means to reduce the variation and level of patient exposure to radiation.
The investigators expect the radiation dose audit reports and educational seminar will lead to reduced radiation exposure to patients by making technologists more aware of the risks of radiation exposure from CT exams and identifying technologists with higher radiation exams compared with their peers.
The investigators expect the degree to which a technologist is concerned and aware about radiation exposure and cancer risk will be associated with adherence to radiation reduction protocols and the subsequent level of radiation their patients are exposed to when receiving a CT examination.
Detailed description
The use of advanced diagnostic imaging has increased dramatically over the past decade, not only contributing to rising medical costs but also exposure to ionizing radiation, of which CT imaging plays a prominent role because it requires a relatively high dose of radiation to produce an image when compared to conventional X-rays. The growth in the use of CT imaging along with all other advanced medical imaging has been well documented, and taken as a whole the use of these services has grown quicker than all other services provided by physicians. Research has also shown great variability in the amount of radiation exposure to individual patients, even when patient and other characteristics are controlled for. Given the increase in the use of CT imaging and the variability in radiation exposure between similar imaging exams, it is important to study ways of standardizing and reducing radiation levels from CT imaging. Little is understood about the role of CT technologists' attitudes and how they may influence patient radiation exposure, therefore, this project also give us the opportunity to survey the technologists and determine if there is a relationship between technologist attitudes and awareness and the radiation exposure of patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Reports and Educational Seminar | Experimental | Behavioral: Radiation Dose Audit Reports, Behavioral: Educational Seminar: Radiation Dose Reduction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Group Health CT Technologist from Capitol Hill, Tacoma and Bellevue Clinics
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Radiation Dose Audit ReportsAudit reports by CT technologist, with graphs of radiation dose levels of 20 exams from each of the 4 most common CT exams. Reports show the distribution of radiation dose levels by each exam type, and compares the technologist's dose levels to the overall levels from the clinic where they work and to the United Kingdom's 2003 Reference Dose. Prior to the graphs, the reports include an introductory page explaining the organization of the report and defining the dosimetry metrics. The final page of the report lists exams meriting individual review because their doses are higher than that of the clinic averages. | Behavioural | Dose Reports and Educational Seminar |
| Educational Seminar: Radiation Dose ReductionSeminar led by a Radiologic Physicist and Radiologist. Discussion of the parameters associated with radiation dosage from CT exams and methods for changing these parameters to lower radiation dose. | Behavioural | Dose Reports and Educational Seminar |
Primary outcome
Radiation dose levels (measured by dose linear product (DLP) and effective dose (ED)) from CT exams as a measure of the effectiveness of radiation dose audit reporting and educational intervention for lowering patient exposure to radiation from CT exams.
Time frame: April 2011 and September 2011
We will report dose data at two time points, April 2011 (data for these reports collect from November 2010 to March 2011), and September 2011 (data collected from April 2011 to August 2011), and compare the data from the two time points to see if there was a change in dose levels (DLP and ED) for the time period (April to August) after the presentation of the first audit reports and delivery of the educational interventions to the CT technologists.
1 secondary outcome
CT Tech technologists attitudes and awareness towards radiation exposure from CT imaging
Time frame: April 2011 to September 2011
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
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.
Diana Miglioretti, PhD principal investigator
Group Health Research Institute
Questions about this trial
What is this clinical trial studying?
A study testing Radiation Dose Audit Reports and Educational Seminar: Radiation Dose Reduction in people with Decrease Variability and Amount of Radiation Dose From CT Exams, run by Kaiser Permanente.
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 17 Feb 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Radiation dose levels (measured by dose linear product (DLP) and effective dose (ED)) from CT exams as a measure of the effectiveness of radiation dose audit reporting and educational intervention for lowering patient exposure to radiation from CT exams. (time frame: April 2011 and September 2011). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2022.