Attitudes About CT UtilizationCT ConsentNCT01174836
Patient and Physician Attitudes About Informed Consent for Emergency Department (ED) Computerized Axial Tomography (CT) Scans
A study testing Educational session in people with Attitudes About CT Utilization, run by Lehigh Valley Hospital.
Trial summary
Hypothesis: The majority of Emergency physicians and patients do not feel that specific informed consent should be obtained for ED CT scans. Secondary Hypothesis: Emergency attending physicians and residents will have similar attitudes about CT scan consent issues. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Attitudes About CT Utilization
- What is being tested?
- Educational session
- How many people
- 77 participants
- Where
- No sites listed yet
- Study dates
- Aug 2009to Dec 2010
- 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
- Current ED resident and attending physicians
- An ED patient (or their surrogate) that is able to understand and respond in writing to the questions given.
Who cannot join
- Anyone who declines to participate.
- An ED patient who is not able to understand questions or respond in writing to the questions given (and does not have a surrogate that understands questions and respond in writing to the questions given).
About this study
Hypothesis: The majority of Emergency physicians and patients do not feel that specific informed consent should be obtained for ED CT scans.
Secondary Hypothesis: Emergency attending physicians and residents will have similar attitudes about CT scan consent issues. Physician attitudes toward obtaining consent for CT scans will change after an educational program about the associated risks.
Read the detailed description
ED residents and ED attendings who attend grand rounds will be given a survey and asked to anonymously complete the first portion before grand rounds (Figure 1, example A). The first portion will assess basic demographics, CT ordering patterns and experiences, and attitudes about informed consent. They will be provided with an educational program at grand rounds that reviews current literature relevant to CT utilization and consent issues. After the lecture they will be asked to complete the second section of the survey (Figure 1, Example B). Both portions of the survey will be simultaneously returned in a sealed envelope and placed in a collection box at grand rounds.
ED attendings who do not attend grand rounds will only be asked to complete the first portion of the survey (Figure 1, example A). Resident or attending consent to participate will not be coerced, and participation will be implied by completion of the survey.
- Conditions
- Attitudes About CT Utilization
- Being tested
- Educational session
- Keywords
- CT utilization, physician attitudes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational sessionOther
Physicians will have a brief education session provided in powerpoint about the risks of CT
What is being measured
The primary outcome is the main question the study is designed to answer.
Survey response to physician attitudes about ordering CT
Before and after education physicians will be surveyed as to the attitudes about ordering ct's
Measured: 30 minutes (after lecture) resurvey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2010 (estimated)
- Study startAug 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attitudes About CT UtilizationStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lehigh Valley Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marna Rayl Greenberg, Lehigh Valley Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01174836
- Sponsor's protocol ID
- 2009-0807
- Acronym
- CT Consent
- Status last verified
- Apr 2012
- First submitted
- 2 Aug 2010
- Last updated
- 26 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient and Physician Attitudes About Informed Consent for Emergency Department (ED) Computerized Axial Tomography (CT) Scans
- ClinicalTrials.gov ID
- NCT01174836
- Acronym / sponsor ID
- CT Consent / 2009-0807
- Conditions
- Attitudes About CT Utilization
- Keywords
- CT utilization, physician attitudes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Lehigh Valley HospitalUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 4 Aug 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.
Hypothesis: The majority of Emergency physicians and patients do not feel that specific informed consent should be obtained for ED CT scans.
Secondary Hypothesis: Emergency attending physicians and residents will have similar attitudes about CT scan consent issues. Physician attitudes toward obtaining consent for CT scans will change after an educational program about the associated risks.
Detailed description
ED residents and ED attendings who attend grand rounds will be given a survey and asked to anonymously complete the first portion before grand rounds (Figure 1, example A). The first portion will assess basic demographics, CT ordering patterns and experiences, and attitudes about informed consent. They will be provided with an educational program at grand rounds that reviews current literature relevant to CT utilization and consent issues. After the lecture they will be asked to complete the second section of the survey (Figure 1, Example B). Both portions of the survey will be simultaneously returned in a sealed envelope and placed in a collection box at grand rounds.
ED attendings who do not attend grand rounds will only be asked to complete the first portion of the survey (Figure 1, example A). Resident or attending consent to participate will not be coerced, and participation will be implied by completion of the survey.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Current ED resident and attending physicians
- An ED patient (or their surrogate) that is able to understand and respond in writing to the questions given.
Key exclusion criteria (2 listed)
- Anyone who declines to participate.
- An ED patient who is not able to understand questions or respond in writing to the questions given (and does not have a surrogate that understands questions and respond in writing to the questions given).
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 |
|---|---|---|
| Educational sessionPhysicians will have a brief education session provided in powerpoint about the risks of CT | Other | – |
Primary outcome
Survey response to physician attitudes about ordering CT
Time frame: 30 minutes (after lecture) resurvey
Before and after education physicians will be surveyed as to the attitudes about ordering ct's
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 26 Apr 2012.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Educational session in people with Attitudes About CT Utilization, run by Lehigh Valley Hospital.
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 2 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 26 Apr 2012. 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?
Survey response to physician attitudes about ordering CT (time frame: 30 minutes (after lecture) resurvey). 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 26 Apr 2012; AzTrials last refreshed its copy on 7 Nov 2026.