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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06010836
Other study ID # IRB00268333
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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