Anesthesia Counseling, Consent, & Professionalism

NCT06010836 | Completed Results

• 1 other identifier: IRB00268333
• Study Type: interventional
• Target: 257
• Locations: 1 country
• Sites: 1

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.

Conditions

Communication; Preoperative; Ethics

Keywords

Communication; Medical ethics; Professionalism

Outcome Measures

Primary Outcomes (3)

• Number of Participants Who Recall Anesthesia Team Members

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

  up to 3 days after surgery

• Number of Participants Who Recall Anesthetic Risks

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

  up to 3 days after surgery

• 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. Standard deviation is reported.

  up to 3 days after surgery

Secondary Outcomes (2)

• Number of Participants Satisfied With Anesthesia Conversation

  up to three days after surgery

• Preoperative Anxiety as Assessed by Questionnaire Developed by Study Team

  up to 3 days after surgery

Study Arms (2)

Control

NO INTERVENTION

Group getting standard treatment without script guided intervention in the preoperative period

Script guided intervention

EXPERIMENTAL

Group getting script guided intervention during the preoperative conversation

Behavioral: Script guided conversation

Interventions

Script guided conversation BEHAVIORAL

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

Script guided intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 and up
• Elective Procedures
• English-speaking
• Consenting for general anesthesia

You may not qualify if:

• Obstetric patients
• Prisoners
• Emergency cases
• Patients under age 18
• Patients don't speak English
• Not consented for general anesthesia

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Associate Professor
• Organization: Johns Hopkins

jsampso4@jhmi.edu

4109552611

Study Officials

• John Sampson, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2023
• First Posted: August 25, 2023
• Study Start: November 1, 2021
• Primary Completion: November 17, 2022
• Study Completion: August 1, 2023
• Last Updated: December 20, 2024
• Results First Posted: December 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)