search
Back to results

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

Primary Purpose

Attitudes About CT Utilization

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Educational session
Sponsored by
Lehigh Valley Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional health services research trial for Attitudes About CT Utilization focused on measuring CT utilization, physician attitudes

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Survey response to physician attitudes about ordering CT
    Before and after education physicians will be surveyed as to the attitudes about ordering ct's

    Secondary Outcome Measures

    Full Information

    First Posted
    August 2, 2010
    Last Updated
    April 25, 2012
    Sponsor
    Lehigh Valley Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01174836
    Brief Title
    Patient and Physician Attitudes About Informed Consent for Emergency Department (ED) Computerized Axial Tomography (CT) Scans
    Acronym
    CT Consent
    Official Title
    Patient and Physician Attitudes About Informed Consent for Emergency Department (ED) Computerized Axial Tomography (CT) Scans
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2009 (undefined)
    Primary Completion Date
    December 2010 (Actual)
    Study Completion Date
    December 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Lehigh Valley Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Attitudes About CT Utilization
    Keywords
    CT utilization, physician attitudes

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    77 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Other
    Intervention Name(s)
    Educational session
    Intervention Description
    Physicians will have a brief education session provided in powerpoint about the risks of CT
    Primary Outcome Measure Information:
    Title
    Survey response to physician attitudes about ordering CT
    Description
    Before and after education physicians will be surveyed as to the attitudes about ordering ct's
    Time Frame
    30 minutes (after lecture) resurvey

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility 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).

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs