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Anesthesia Consent Process

Sponsor
University of Chicago (Other)
Overall Status
Recruiting
CT.gov ID
NCT05102487
Collaborator
(none)
100
Enrollment
1
Location
12.5
Anticipated Duration (Months)
8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Currently at University of Chicago Medical Center (UCMC) consent for anesthesia is obtained verbally by qualified anesthesia providers. Later this year, we will be moving to a written informed consent form for anesthesia that must be signed by patients before proceeded with elective surgery. We aim to study patient satisfaction and retention of information presented before and after this change is made.

After consent for anesthesia is obtained, study personnel will approach patients >= 18 years of age scheduled for elective surgery and, after seeking verbal consent for this study, will administer a questionnaire which will assess patient satisfaction and retention of the risks that were presented.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Currently at UCMC consent for anesthesia is obtained verbally by qualified anesthesia providers. Later this year, we will be moving to a written informed consent form for anesthesia that must be signed by patients before proceeded with elective surgery. We aim to study patient satisfaction and retention of information presented before and after this change is made.

    Study Procedures After consent for anesthesia is obtained, study personnel will approach patients >= 18 years of age scheduled for elective surgery and, after seeking verbal consent for this study, will administer a questionnaire which will assess patient satisfaction and retention of the risks that were presented.

    Demographic data will be recorded, including age, sex, classification of surgery (by service), urgency of case, as well as role of person obtaining anesthesia consent (resident vs. CRNA/APN vs. attending anesthesiologist). Method of obtaining anesthesia consent will also be recorded. Patient identifiers, including name, MRN and date of birth will NOT be recorded as part of this study.

    Patients will be approached for participation in this study preoperatively, in the pre-op holding area, immediately after anesthesia consent is obtained by the appropriate anesthesia provider. The patient's electronic medical record will NOT be accessed in order to pre-screen for participation no PHI will be collected in this study.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Patient Comprehension, Retention and Satisfaction With Anesthesia Consent Process
    Actual Study Start Date :
    Oct 15, 2021
    Anticipated Primary Completion Date :
    Oct 1, 2022
    Anticipated Study Completion Date :
    Oct 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Patient satisfaction [Upon receiving consent for anesthesia, pre-operatively]

      How well patients are satisfied with the anesthesia consent process by using a 6 question questionnaire developed for this study.

    Secondary Outcome Measures

    1. Patient Retention [Upon receiving consent for anesthesia, pre-operatively]

      How well the patient was able to retain the information disclosed during the anesthesia by consent by using a 6 question questionnaire developed for this study.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • English speaking Age> 18 years old
    Exclusion Criteria:
    • Emergency cases Pt unable to consent for themselves Age <18 yo Pregnant women for delivery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Chicago Medical Center Chicago Illinois United States 60637

    Sponsors and Collaborators

    • University of Chicago

    Investigators

    • Principal Investigator: Junaid Nizamuddin, MD, University of Chicago

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Chicago
    ClinicalTrials.gov Identifier:
    NCT05102487
    Other Study ID Numbers:
    • IRB21-1573
    First Posted:
    Nov 1, 2021
    Last Update Posted:
    Nov 1, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Nov 1, 2021