Patient and Physician Attitudes About Informed Consent for Emergency Department (ED) Computerized Axial Tomography (CT) Scans (CT Consent)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01174836
Recruitment Status : Completed
First Posted : August 4, 2010
Last Update Posted : April 26, 2012
Information provided by (Responsible Party):
Marna Rayl Greenberg, Lehigh Valley Hospital

Brief 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. Physician attitudes toward obtaining consent for CT scans will change after an educational program about the associated risks.

Condition or disease Intervention/treatment
Attitudes About CT Utilization Other: Educational session

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 : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Patient and Physician Attitudes About Informed Consent for Emergency Department (ED) Computerized Axial Tomography (CT) Scans
Study Start Date : August 2009
Primary Completion Date : December 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Other: Educational session
    Physicians will have a brief education session provided in powerpoint about the risks of CT

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Responsible Party: Marna Rayl Greenberg, Director of Emergency Medicine Research, Lehigh Valley Hospital Identifier: NCT01174836     History of Changes
Other Study ID Numbers: 2009-0807
First Posted: August 4, 2010    Key Record Dates
Last Update Posted: April 26, 2012
Last Verified: April 2012

Keywords provided by Marna Rayl Greenberg, Lehigh Valley Hospital:
CT utilization
physician attitudes

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes