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Completed

NCT Number: NCT06010836

Anesthesia 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Script guided conversation

Behavioral

Patients getting script guided intervention of 3 domains in the preoperative period

Primary outcomes

  1. Number of Participants Who Recall Anesthesia Team Members

    Time frame: up to 3 days after surgery

    Postoperative recall of anesthesia conversation. Recall of team members score 0-100 with higher score indicating better recall of anesthesia team members.

  2. Number of Participants Who Recall Anesthetic Risks

    Time frame: up to 3 days after surgery

    anesthesia risks, (0) don't remember any risks - (3) remembered 3 or more correctly

  3. Postoperative Understanding of Anesthetic Plan as Assessed by the Questionnaire Developed by the Study Team

    Time frame: up to 3 days after surgery

    Demonstrate understanding of anesthetic plan; score total 0-100 with a higher score more understanding. Standard deviation is reported.

Secondary outcomes

  1. Number of Participants Satisfied With Anesthesia Conversation

    Time frame: up to three days after surgery

    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)

  2. Preoperative Anxiety as Assessed by Questionnaire Developed by Study Team

    Time frame: up to 3 days after surgery

    Patients are asked about any change in anxiety after the preoperative conversation using likert scale extremely reduced (5) to extremely more anxious (1)

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

Anesthesiology Counseling, Consent, & Professionalism

Acronym: ACCP

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Aug 25, 2023
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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