EmergencyNCT02040896
Who Contributes to the Ordering of CT Scans in Emergency Department Patients?
An observational study of Emergency, run by Duke University at 1 site in United States.
Trial summary
The primary objectives are: 1. To investigate which healthcare workers and other individuals contribute to the decision to order computed tomography (CT) scans for emergency department (ED) patients. 2. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Emergency
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jan 2015
- Phase
- Observational
- 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
Study population: Patients from age 0 to <17 years, and patients age 18 years and older with traumatic and non-traumatic presentations, who visit Adult and Pediatric EDs and receive a CT scan during their ED visit
Who may be able to join
- Patients from age 0 to <17 years, and patients age 18 years and older with traumatic and non-traumatic presentations, who visit Adult and Pediatric EDs and receive a CT scan during their ED visit
Who cannot join
- Patients older than 17, yet younger then 18.
- Patients who are unable to consent and who do not have a legally authorized representative.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Hospital
Durham, North Carolina, 27710
About this study
Official title: Who Contributes to the Ordering of Computed Tomography in Emergency Department Patients? A Prospective Survey Study
The primary objectives are:
- To investigate which healthcare workers and other individuals contribute to the decision to order computed tomography (CT) scans for emergency department (ED) patients.
- To investigate the specific reasons healthcare workers and other individuals order or request CT scans for ED patients.
- To determine the frequency of clinically important actions following CT scan results.
Once the drivers of ED CT utilization are identified, interventions including education, incentives for compliance with evidence-based best practices, and interventions for noncompliance could be targeted appropriately.
- Conditions
- Emergency
- Keywords
- computed tomography, emergency, CT scan, ordering behavior, diagnosis, radiation
- Medical subject headings
- Emergencies, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | All consecutive emergency department patients undergoing CT during study hours will be prospectively enrolled, except for those meeting pre-specified exclusion criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
CT scans utilization
Results will be categorized by body region of CT and patient age. For each CT region and age category, the percentage of CT scans requested by each demographic group (e.g., patient, emergency physician, etc.), will be reported, with 95% confidence intervals.
CTs not requested by emergency physicians, the percentage of each type of scan requested by each demographic group will be reported, with 95% confidence intervals.
Measured: January 2014 - January 2015
Secondary outcomes (1)
Abnormal vs. normal CT scans
The frequency of abnormal CT results and clinical interventions will be calculated, for CTs requested by emergency physicians and for those not requested by emergency physicians (this includes all other parties).
Measured: January 2014 - January 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmergencyStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joshua S Broder, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02040896
- Sponsor's protocol ID
- Pro00047697
- Status last verified
- Jan 2020
- First submitted
- 17 Jan 2014
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Who Contributes to the Ordering of Computed Tomography in Emergency Department Patients? A Prospective Survey Study
- ClinicalTrials.gov ID
- NCT02040896
- Acronym / sponsor ID
- Pro00047697
- Conditions
- Emergency
- Keywords
- computed tomography, emergency, CT scan, ordering behavior, diagnosis, radiation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 20 Jan 2014 (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 primary objectives are:
- To investigate which healthcare workers and other individuals contribute to the decision to order computed tomography (CT) scans for emergency department (ED) patients.
- To investigate the specific reasons healthcare workers and other individuals order or request CT scans for ED patients.
- To determine the frequency of clinically important actions following CT scan results.
Once the drivers of ED CT utilization are identified, interventions including education, incentives for compliance with evidence-based best practices, and interventions for noncompliance could be targeted appropriately.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –All consecutive emergency department patients undergoing CT during study hours will be prospectively enrolled, except for those meeting pre-specified exclusion criteria. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients from age 0 to <17 years, and patients age 18 years and older with traumatic and non-traumatic presentations, who visit Adult and Pediatric EDs and receive a CT scan during their ED visit
Key inclusion criteria (1 listed)
- Patients from age 0 to <17 years, and patients age 18 years and older with traumatic and non-traumatic presentations, who visit Adult and Pediatric EDs and receive a CT scan during their ED visit
Key exclusion criteria (2 listed)
- Patients older than 17, yet younger then 18.
- Patients who are unable to consent and who do not have a legally authorized representative.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CT scans utilization
Time frame: January 2014 - January 2015
Results will be categorized by body region of CT and patient age. For each CT region and age category, the percentage of CT scans requested by each demographic group (e.g., patient, emergency physician, etc.), will be reported, with 95% confidence intervals. CTs not requested by emergency physicians, the percentage of each type of scan requested by each demographic group will be reported, with 95% confidence intervals.
1 secondary outcome
Abnormal vs. normal CT scans
Time frame: January 2014 - January 2015
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 27 Mar 2020.
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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.
Joshua S Broder, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergency, run by Duke University 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 2 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 27 Mar 2020. 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 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?
CT scans utilization (time frame: January 2014 - January 2015). 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 27 Mar 2020.