Anesthesia Consent Process

Patient Comprehension, Retention and Satisfaction With Anesthesia Consent Process

Currently at University of Chicago Medical Center (UCMC) consent for anesthesia is obtained verbally by qualified anesthesia providers. Later this year, the investigators will be moving to a written informed consent form for anesthesia that must be signed by patients before proceeding with elective surgery. The department's aim is 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.

Study Overview

• Status: Withdrawn
• Conditions: Anesthesia; Patient Satisfaction; Anesthesia Risks; Anesthesia Consent; Consent Retention

Detailed Description

Currently at UCMC consent for anesthesia is obtained verbally by qualified anesthesia providers. Later this year, the investigators will be moving to a written informed consent form for anesthesia that must be signed by patients before proceeded with elective surgery. The aim is 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 Type: Observational

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All anesthesia cases that fit the criteria above will be considered for enrollment.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	How well patients are satisfied with the anesthesia consent process by using a 6 question questionnaire developed for this study.	Upon receiving consent for anesthesia, pre-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Retention	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.	Upon receiving consent for anesthesia, pre-operatively

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2021
• Primary Completion (Actual): May 28, 2024
• Study Completion (Actual): May 28, 2024

Study Registration Dates

• First Submitted: October 19, 2021
• First Submitted That Met QC Criteria: October 19, 2021
• First Posted (Actual): November 1, 2021

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 28, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IRB21-1573

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No