Anesthesia Counseling, Consent, & Professionalism (ACCP)

Anesthesiology Counseling, Consent, & Professionalism

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.

Study Overview

• Status: Completed
• Conditions: Communication; Ethics; Preoperative
• Intervention / Treatment: Behavioral: Script guided conversation

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 257
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Group getting standard treatment without script guided intervention in the preoperative period
Experimental: Script guided intervention; Group getting script guided intervention during the preoperative conversation	Behavioral: Script guided conversation; Patients getting script guided intervention of 3 domains in the preoperative period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Recall Anesthesia Team Members	Postoperative recall of anesthesia conversation. Recall of team members score 0-100 with higher score indicating better recall of anesthesia team members.	up to 3 days after surgery
Number of Participants Who Recall Anesthetic Risks	anesthesia risks, (0) don't remember any risks - (3) remembered 3 or more correctly	up to 3 days after surgery
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. Standard deviation is reported.	up to 3 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Satisfied With Anesthesia Conversation	Number of participants satisfied with anesthetic conversation assessed by questionnaire developed by study team; using likert scale rating; extremely satisfied (5) to extremely dissatisfied (1)	up to three days after surgery
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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: John Sampson, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): November 17, 2022
• Study Completion (Actual): August 1, 2023

Study Registration Dates

• First Submitted: May 29, 2023
• First Submitted That Met QC Criteria: August 21, 2023
• First Posted (Actual): August 25, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: November 12, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Medical ethics; Communication; Professionalism
• Other Study ID Numbers: IRB00268333

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: None to be shared

Drug and device information, study documents

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