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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marna Rayl Greenberg, Lehigh Valley Hospital
ClinicalTrials.gov Identifier:
NCT01174836
First received: August 2, 2010
Last updated: April 25, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention
Attitudes About CT Utilization
 Other: Educational session

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lehigh Valley Hospital:

Primary Outcome Measures:
  • Survey response to physician attitudes about ordering CT [ Time Frame: 30 minutes (after lecture) resurvey ] [ Designated as safety issue: Yes ]
    Before and after education physicians will be surveyed as to the attitudes about ordering ct's


Enrollment: 77
Study Start Date: August 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Educational session
    Physicians will have a brief education session provided in powerpoint about the risks of CT
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Marna Rayl Greenberg, Director of Emergency Medicine Research, Lehigh Valley Hospital
ClinicalTrials.gov Identifier: NCT01174836     History of Changes
Other Study ID Numbers: 2009-0807
Study First Received: August 2, 2010
Last Updated: April 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Lehigh Valley Hospital:
CT utilization
physician attitudes

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013