Anesthesia Counseling, Consent, & Professionalism

Communication Clinical Trial

— ACCP  

Official title:

Anesthesiology Counseling, Consent, & Professionalism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06010836
• Other study ID #: IRB00268333
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: August 1, 2023

Study information

• Verified date: September 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The anesthesia consent form has become a standard before surgery. However, verbal aspects of anesthesia consent and of the value of the preoperative anesthesia discussion has not been addressed. This study will use preoperative discussions and postoperative patient questionnaires to examine the degree of awareness that the patients and the patients families have regarding what general anesthesia is, the responsibilities of the anesthesiologist, and the specifics of what the participants are agreeing to by signing the consent form.

Description:

There is a substantial body of work regarding the written anesthesia consent form. As a result, the written anesthesia consent form has become a standard requirement throughout the United States of America. However, there has been little examination of verbal aspects of anesthesia consent and of the value of the preoperative anesthesia discussion that should take place prior to surgery. Non-anesthesia medical studies have indicated that inadequate patient-physician communication and an inadequate patient-physician relationship will result in misunderstanding and an increased malpractice risk. Lack of understanding of the duties and responsibilities of anesthesiologists is also damaging to the professional status of the field of anesthesiology. This study will utilize patient interviews and questionnaires to examine the degree of awareness that the patients and the patients families possess regarding what general anesthesia is, the duties and responsibilities of the anesthesiologist, the role of the anesthesiologist within the operating room and the specifics of what the participants are agreeing to by signing the consent form. If it is determined that a more structured and thorough pre-anesthesia discussion will help patients and the patients families understand what general anesthesia is, understand the specific responsibilities of anesthesiology providers, understand the professional status of anesthesiologists, give the participants a better feeling of autonomy and better understand what the participants are agreeing to by signing the consent form, then there will be substantial ramifications to the priority and importance given to pre-anesthesia discussions nationwide. Secondary benefits include influences on anesthesia residency training and improved patient satisfaction with the anesthesia experience.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 257
• Est. completion date: August 1, 2023
• Est. primary completion date: November 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 and up
• Elective Procedures
• English-speaking
• Consenting for general anesthesia

Exclusion Criteria:

• Obstetric patients
• Prisoners
• Emergency cases
• Patients under age 18
• Patients don't speak English
• Not consented for general anesthesia

Related Conditions & MeSH terms

• Communication
• Ethics
• Preoperative

Intervention

Behavioral:
• Script guided conversation
Patients getting script guided intervention of 3 domains in the preoperative period

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative recall of conversation about the anesthesia as assessed by questionnaire by developed by study team	Recall of team members score 0-100 with higher score indicating better recall of anesthesia team members	up to 3 days after surgery
Primary	Postoperative recall of anesthesia risks as assessed by questionnaire by developed by study team	anesthesia risks, (0) don't remember any risks - (3) remembered 3 or more correctly	up to 3 days after surgery
Primary	Postoperative recall of anesthetic plan as assessed by questionnaire by developed by study team	Recall of anesthetic plan; one question correct signifies recall	up to 3 days after surgery
Primary	Postoperative understanding of anesthetic plan as assessed by the questionnaire developed by the study team	Demonstrate understanding of anesthetic plan; score total 0-100 with a higher score more understanding.	up to 3 days after surgery
Secondary	Patient Satisfaction with anesthesia conversation as assessed by questionnaire developed by the study team	Rating of satisfaction with anesthetic conversation using likert scale rating; extremely satisfied (5) to extremely dissatisfied (1)	up to three days after surgery
Secondary	Quality of explanation of anesthesia plan as assessed by questionnaire developed by study team	Patients rate quality of anesthesia plan using likert scale very detailed (5) to very poor (1)	up to three days after surgery
Secondary	Preoperative anxiety as assessed by questionnaire developed by study team	Patients are asked about any change in anxiety after the preoperative conversation using likert scale extremely reduced (5) to extremely more anxious (1)	up to 3 days after surgery