Clinical trial NCT06010836: Anesthesia Counseling, Consent, & Professionalism
Official title: Anesthesiology Counseling, Consent, & Professionalism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Communication
Preoperative
Ethics
Keywords: Communication
Medical ethics
Professionalism
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 257
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Who Recall Anesthesia Team Members
timeFrame: up to 3 days after surgery
measure: Number of Participants Who Recall Anesthetic Risks
timeFrame: up to 3 days after surgery
measure: Postoperative Understanding of Anesthetic Plan as Assessed by the Questionnaire Developed by the Study Team
timeFrame: up to 3 days after surgery
Secondary outcomes:
measure: Number of Participants Satisfied With Anesthesia Conversation
timeFrame: up to three days after surgery
measure: Preoperative Anxiety as Assessed by Questionnaire Developed by Study Team
timeFrame: up to 3 days after surgery
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: John Sampson, MD
role: PRINCIPAL_INVESTIGATOR
References: