- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01174836
Patient and Physician Attitudes About Informed Consent for Emergency Department (ED) Computerized Axial Tomography (CT) Scans (CT Consent)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
30 minutes (after lecture) resurvey
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009-0807
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.