Anesthesia Consent Process

Anesthesia Clinical Trial

Official title:

Patient Comprehension, Retention and Satisfaction With Anesthesia Consent Process

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05102487
• Other study ID #: IRB21-1573
• Status: Recruiting
• Start date: October 15, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: October 2021
• Source: University of Chicago
• Contact: Junaid Nizamuddin, MD
• Phone: (773) 702-4538
• Email: jnizamuddin[@]dacc.uchicago.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 31, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Patient Satisfaction

Locations

Country	Name	City	State
United States	University of Chicago Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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