Radiation SafetyNCT01268085
Radiation Safety Alert
A study testing Radiation Alert in people with Radiation Safety, run by Montefiore Medical Center at 1 site in United States.
Trial summary
In recent years, multiple articles have highlighted the increased risk of developing cancer from ionizing radiation. The risk increases with higher radiation doses, and accumulates with repeated scans. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Radiation Safety
- What is being tested?
- Radiation Alert
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15,969 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Sep 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All inpatient providers who order a CAT Scan
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: Radiation Safety Alert- A Randomized Controlled Trial
In recent years, multiple articles have highlighted the increased risk of developing cancer from ionizing radiation. The risk increases with higher radiation doses, and accumulates with repeated scans.
Hospitals with computerized physician order entry systems (CPOE) have the unique opportunity to use decision support on radiation safety to influence a physician's ordering practice in real-time. An ideal decision support tool for radiation safety will educate the physician about the dangers of cumulative ionizing radiation, present the patient's image history, and guide the provider to the best modality that meets the patient's diagnostic needs with as little radiation exposure as possible. The design challenge is to create a decision support tool that appropriately protects the investigators patients from overutilization of CAT scans, without inadvertently leading to underutilization of CAT scans or inappropriate utilization of alternative tests.
This research protocol proposes to study one such design at a large, academic medical center.
Read the detailed description
Ever since the 1979 Nobel Prize was awarded to Cormack and Hounsfield for the development of computer assisted tomography (CAT scans, this technology has revolutionized the practice of medicine. CAT scans combine special x-ray equipment with sophisticated computers to produce images of the inside of the body. They are widely used, noninvasive medical tests that help physicians diagnose and treat numerous medical conditions. In 2000, the U.S. Food and Drug Administration (FDA) and the Conference of Radiation Control Program Directors (CRCPD) estimated that approximately 40 million CAT scans are performed annually.
In recent years, multiple articles have highlighted the increased risk of developing cancer from ionizing radiation. The risk increases with higher radiation doses, and accumulates with repeated scans. The 2007 American College of Radiology's white paper on radiation dose in medicine by Amis, et al., emphasizes the importance of addressing this issue, and proposes a plan to educate all stakeholders in the principles of radiation safety and appropriate utilization of imaging. In addition, in 2007 the Society for Pediatric Radiology joined forces with the American College of Radiology and several other medical societies to form the Alliance for Radiation Safety in Pediatric Imaging (the Image Gently Alliance). The charge of the Alliance is summarized in its mission statement: "…to raise awareness in the imaging community of the need to adjust radiation dose when imaging children."
Hospitals with computerized physician order entry systems (CPOE) have the unique opportunity to use decision support on radiation safety to influence a physician's ordering practice in real-time. CPOE and decision support technology have been successfully used to positively effect physician ordering behavior and improve patient safety in many aspects of patient care, including the ordering of radiology tests. An ideal decision support tool for radiation safety will educate the physician about the dangers of cumulative ionizing radiation, present the patient's image history, and guide the provider to the best modality that meets the patient's diagnostic needs with as little radiation exposure as possible. The design challenge is to create a decision support tool that appropriately protects our patients from overutilization of CAT scans, without inadvertently leading to underutilization of CAT scans or inappropriate utilization of alternative tests. This research protocol proposes to study one such design at a large, academic medical center.
- Conditions
- Radiation Safety
- Being tested
- Radiation Alert, Control
- Keywords
- Radiation Safety, Computerized Physician Order Entry, Decision Support, Cat Scans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation AlertOther
A radiation safety pop-up alert with a message about the dangers of cumulative ionizing radiation, the patient's cumulative CAT scan history, and the most recent imaging test from any modality of the same body part
ControlOther
Control with no inverention
| Study group | Role | What they receive |
|---|---|---|
| Radiation Safety Alert | Experimental | A provider placing an electronic order for a CAT scan will receive a radiation safety pop-up alert with a message about the dangers of cumulative ionizing radiation, the patient's cumulative CAT scan history, and the most recent imaging test from any modality of the same body part. Receives: Other: Radiation Alert |
| Control | Active comparator | Parallel control with no intervention Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ordering behavior in response to alert
The proportion of patients that continue on with the CAT scan order, choose an alternative, or cancel the order in response to the radiation safety alert, as compared to control.
Measured: After 6 months of data collection
Secondary outcomes (1)
Appropriateness of Imaging Test Ordered in Response to Safety Alert
Decisions to proceed with the CAT scan order, choose an alternative or cancel the order will be evaluated for appropriateness by retrospective chart review by two independent radiologists. Discrepancies will be resolved by consensus.
Measured: After 6 months of data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionSep 2011
- Study completionSep 2011
Why it stopped: Error in randomization resulted in early study termination.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Radiation SafetyStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 15,969 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Amis, MD, Principal investigator, Montefiore Medical CenterJason S Adelman, MD, MS, Study director, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01268085
- Sponsor's protocol ID
- 10-10-330
- Status last verified
- Jun 2018
- First submitted
- 15 Dec 2010
- Last updated
- 8 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Amis ES Jr, Butler PF, Applegate KE, Birnbaum SB, Brateman LF, Hevezi JM, Mettler FA, Morin RL, Pentecost MJ, Smith GG, Strauss KJ, Zeman RK; American College of Radiology. American College of Radiology white paper on radiation dose in medicine. J Am Coll Radiol. 2007 May;4(5):272-84. doi: 10.1016/j.jacr.2007.03.002.
PubMed 17467608Goske MJ, Applegate KE, Bell C, Boylan J, Bulas D, Butler P, Callahan MJ, Coley BD, Farley S, Frush DP, McElveny C, Hernanz-Schulman M, Johnson ND, Kaste SC, Morrison G, Strauss KJ. Image Gently: providing practical educational tools and advocacy to accelerate radiation protection for children worldwide. Semin Ultrasound CT MR. 2010 Feb;31(1):57-63. doi: 10.1053/j.sult.2009.09.007.
PubMed 20102697
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiation Safety Alert- A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01268085
- Acronym / sponsor ID
- 10-10-330
- Conditions
- Radiation Safety
- Keywords
- Radiation Safety, Computerized Physician Order Entry, Decision Support, Cat Scans
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Error in randomization resulted in early study termination.
- Enrolment
- 15,969 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Dec 2010 (actual)
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 29 Dec 2010 (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.
In recent years, multiple articles have highlighted the increased risk of developing cancer from ionizing radiation. The risk increases with higher radiation doses, and accumulates with repeated scans.
Hospitals with computerized physician order entry systems (CPOE) have the unique opportunity to use decision support on radiation safety to influence a physician's ordering practice in real-time. An ideal decision support tool for radiation safety will educate the physician about the dangers of cumulative ionizing radiation, present the patient's image history, and guide the provider to the best modality that meets the patient's diagnostic needs with as little radiation exposure as possible. The design challenge is to create a decision support tool that appropriately protects the investigators patients from overutilization of CAT scans, without inadvertently leading to underutilization of CAT scans or inappropriate utilization of alternative tests.
This research protocol proposes to study one such design at a large, academic medical center.
Detailed description
Ever since the 1979 Nobel Prize was awarded to Cormack and Hounsfield for the development of computer assisted tomography (CAT scans, this technology has revolutionized the practice of medicine. CAT scans combine special x-ray equipment with sophisticated computers to produce images of the inside of the body. They are widely used, noninvasive medical tests that help physicians diagnose and treat numerous medical conditions. In 2000, the U.S. Food and Drug Administration (FDA) and the Conference of Radiation Control Program Directors (CRCPD) estimated that approximately 40 million CAT scans are performed annually.
In recent years, multiple articles have highlighted the increased risk of developing cancer from ionizing radiation. The risk increases with higher radiation doses, and accumulates with repeated scans. The 2007 American College of Radiology's white paper on radiation dose in medicine by Amis, et al., emphasizes the importance of addressing this issue, and proposes a plan to educate all stakeholders in the principles of radiation safety and appropriate utilization of imaging. In addition, in 2007 the Society for Pediatric Radiology joined forces with the American College of Radiology and several other medical societies to form the Alliance for Radiation Safety in Pediatric Imaging (the Image Gently Alliance). The charge of the Alliance is summarized in its mission statement: "…to raise awareness in the imaging community of the need to adjust radiation dose when imaging children."
Hospitals with computerized physician order entry systems (CPOE) have the unique opportunity to use decision support on radiation safety to influence a physician's ordering practice in real-time. CPOE and decision support technology have been successfully used to positively effect physician ordering behavior and improve patient safety in many aspects of patient care, including the ordering of radiology tests. An ideal decision support tool for radiation safety will educate the physician about the dangers of cumulative ionizing radiation, present the patient's image history, and guide the provider to the best modality that meets the patient's diagnostic needs with as little radiation exposure as possible. The design challenge is to create a decision support tool that appropriately protects our patients from overutilization of CAT scans, without inadvertently leading to underutilization of CAT scans or inappropriate utilization of alternative tests. This research protocol proposes to study one such design at a large, academic medical center.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiation Safety Alert | Experimental | Other: Radiation AlertA provider placing an electronic order for a CAT scan will receive a radiation safety pop-up alert with a message about the dangers of cumulative ionizing radiation, the patient's cumulative CAT scan history, and the most recent imaging test from any modality of the same body part. |
| Control | Active comparator | Other: ControlParallel control with no intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All inpatient providers who order a CAT Scan
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 AlertA radiation safety pop-up alert with a message about the dangers of cumulative ionizing radiation, the patient's cumulative CAT scan history, and the most recent imaging test from any modality of the same body part | Other | Radiation Safety Alert |
| ControlControl with no inverention | Other | Control |
Primary outcome
Ordering behavior in response to alert
Time frame: After 6 months of data collection
The proportion of patients that continue on with the CAT scan order, choose an alternative, or cancel the order in response to the radiation safety alert, as compared to control.
1 secondary outcome
Appropriateness of Imaging Test Ordered in Response to Safety Alert
Time frame: After 6 months of data collection
Results and safety
The study was stopped early (reason given: Error in randomization resulted in early study termination.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2018.
- Background: PubMed 17467608Amis ES Jr, Butler PF, Applegate KE, Birnbaum SB, Brateman LF, Hevezi JM, Mettler FA, Morin RL, Pentecost MJ, Smith GG, Strauss KJ, Zeman RK; American College of Radiology. American College of Radiology white paper on radiation dose in medicine. J Am Coll Radiol. 2007 May;4(5):272-84. doi: 10.1016/j.jacr.2007.03.002.
- Background: PubMed 20102697Goske MJ, Applegate KE, Bell C, Boylan J, Bulas D, Butler P, Callahan MJ, Coley BD, Farley S, Frush DP, McElveny C, Hernanz-Schulman M, Johnson ND, Kaste SC, Morrison G, Strauss KJ. Image Gently: providing practical educational tools and advocacy to accelerate radiation protection for children worldwide. Semin Ultrasound CT MR. 2010 Feb;31(1):57-63. doi: 10.1053/j.sult.2009.09.007.
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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.
Stephen Amis, MD principal investigator
Montefiore Medical Center
Jason S Adelman, MD, MS study director
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiation Alert in people with Radiation Safety, run by Montefiore Medical Center at 1 site in United States.
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: stopped early, as of the sponsor's last update on 8 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was stopped early (reason given: Error in randomization resulted in early study termination.). Results are not available in the source record.
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?
Ordering behavior in response to alert (time frame: After 6 months of data collection). 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 NCT01268085, which also lists 2 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 Jun 2018.