ACCP: Anesthesia Counseling, Consent, & Professionalism

Sponsor
Johns Hopkins University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06010836
Collaborator
(none)
240
1
2
22
10.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Script guided conversation
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Health Services Research
Official Title:
Anesthesiology Counseling, Consent, & Professionalism
Actual Study Start Date :
Nov 1, 2021
Actual Primary Completion Date :
Nov 17, 2022
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Postoperative recall of conversation about the anesthesia as assessed by questionnaire by developed by study team [up to 3 days after surgery]

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

  2. Postoperative recall of anesthesia risks as assessed by questionnaire by developed by study team [up to 3 days after surgery]

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

  3. Postoperative recall of anesthetic plan as assessed by questionnaire by developed by study team [up to 3 days after surgery]

    Recall of anesthetic plan; one question correct signifies recall

  4. Postoperative understanding of anesthetic plan as assessed by the questionnaire developed by the study team [up to 3 days after surgery]

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

Secondary Outcome Measures

  1. Patient Satisfaction with anesthesia conversation as assessed by questionnaire developed by the study team [up to three days after surgery]

    Rating of satisfaction with anesthetic conversation using likert scale rating; extremely satisfied (5) to extremely dissatisfied (1)

  2. Quality of explanation of anesthesia plan as assessed by questionnaire developed by study team [up to three days after surgery]

    Patients rate quality of anesthesia plan using likert scale very detailed (5) to very poor (1)

  3. Preoperative anxiety as assessed by questionnaire developed by study team [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Johns Hopkins Hospital Baltimore Maryland United States 21287

Sponsors and Collaborators

  • Johns Hopkins University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT06010836
Other Study ID Numbers:
  • IRB00268333
First Posted:
Aug 25, 2023
Last Update Posted:
Aug 28, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Johns Hopkins University

Study Results

No Results Posted as of Aug 28, 2023