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

April 25, 2012 updated by: Marna Rayl Greenberg, Lehigh Valley Hospital

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

Completed

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

Interventional

Enrollment (Actual)

77

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

Lehigh Valley Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

August 2, 2010

First Submitted That Met QC Criteria

August 3, 2010

First Posted (Estimate)

August 4, 2010

Study Record Updates

Last Update Posted (Estimate)

April 26, 2012

Last Update Submitted That Met QC Criteria

April 25, 2012

Last Verified

April 1, 2012

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.

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