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Anesthesia Counseling, Consent, & Professionalism (ACCP)

Johns Hopkins University logo

Johns Hopkins University

Status

Completed

Conditions

Preoperative
Ethics
Communication

Treatments

Behavioral: Script guided conversation

Study type

Interventional

Funder types

Other

Identifiers

NCT06010836
IRB00268333

Details and patient eligibility

About

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.

Full 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.

Enrollment

257 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

257 participants in 2 patient groups

Control
No Intervention group
Description:
Group getting standard treatment without script guided intervention in the preoperative period
Script guided intervention
Experimental group
Description:
Group getting script guided intervention during the preoperative conversation
Treatment:
Behavioral: Script guided conversation

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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