Trial Outcomes & Findings for Anesthesia Counseling, Consent, & Professionalism (NCT NCT06010836)

NCT ID: NCT06010836

Last Updated: 2024-12-20

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 257 participants
• Primary outcome timeframe: up to 3 days after surgery
• Results posted on: 2024-12-20

Participant Flow

Participant milestones

Measure	Control Group getting standard treatment without script guided intervention in the preoperative period	Script Guided Intervention Group getting script guided intervention during the preoperative conversation Script guided conversation: Patients getting script guided intervention of 3 domains in the preoperative period
Overall Study STARTED	132	125
Overall Study COMPLETED	121	113
Overall Study NOT COMPLETED	11	12

Reasons for withdrawal

Measure	Control Group getting standard treatment without script guided intervention in the preoperative period	Script Guided Intervention Group getting script guided intervention during the preoperative conversation Script guided conversation: Patients getting script guided intervention of 3 domains in the preoperative period
Overall Study Lost to Follow-up	2	2
Overall Study Case cancelled by surgeon, or reoperation after surgical complication	8	2
Overall Study Poor or absent audio recording for data collection	1	4
Overall Study Did not receive intervention discussion	0	4

Baseline Characteristics

Anesthesia Counseling, Consent, & Professionalism

Baseline characteristics by cohort

Measure	Control n=121 Participants Group getting standard treatment without script guided intervention in the preoperative period	Script Guided Intervention n=113 Participants Group getting script guided intervention during the preoperative conversation Script guided conversation: Patients getting script guided intervention of 3 domains in the preoperative period	Total n=234 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	87 Participants n=5 Participants	85 Participants n=7 Participants	172 Participants n=5 Participants
Age, Categorical >=65 years	34 Participants n=5 Participants	28 Participants n=7 Participants	62 Participants n=5 Participants
Age, Continuous	58 years n=5 Participants	57 years n=7 Participants	57.5 years n=5 Participants
Sex: Female, Male Female	78 Participants n=5 Participants	57 Participants n=7 Participants	135 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants	56 Participants n=7 Participants	99 Participants n=5 Participants
Race/Ethnicity, Customized White	82 Participants n=5 Participants	77 Participants n=7 Participants	159 Participants n=5 Participants
Race/Ethnicity, Customized Black	30 Participants n=5 Participants	25 Participants n=7 Participants	55 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Asian	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	121 Participants n=5 Participants	113 Participants n=7 Participants	234 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Control n=121 Participants Group getting standard treatment without script guided intervention in the preoperative period	Script Guided Intervention n=113 Participants Group getting script guided intervention during the preoperative conversation Script guided conversation: Patients getting script guided intervention of 3 domains in the preoperative period
Number of Participants Who Recall Anesthesia Team Members	30 Participants	49 Participants

PRIMARY outcome

Timeframe: up to 3 days after surgery

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

Outcome measures

Measure	Control n=121 Participants Group getting standard treatment without script guided intervention in the preoperative period	Script Guided Intervention n=113 Participants Group getting script guided intervention during the preoperative conversation Script guided conversation: Patients getting script guided intervention of 3 domains in the preoperative period
Number of Participants Who Recall Anesthetic Risks Recall 1 risk	29 Participants	34 Participants
Number of Participants Who Recall Anesthetic Risks Recall 2 risks	22 Participants	36 Participants
Number of Participants Who Recall Anesthetic Risks Recall 3 or more risks	20 Participants	24 Participants
Number of Participants Who Recall Anesthetic Risks No recall	49 Participants	19 Participants
Number of Participants Who Recall Anesthetic Risks Unknown	1 Participants	0 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Control n=121 Participants Group getting standard treatment without script guided intervention in the preoperative period	Script Guided Intervention n=113 Participants Group getting script guided intervention during the preoperative conversation Script guided conversation: Patients getting script guided intervention of 3 domains in the preoperative period
Postoperative Understanding of Anesthetic Plan as Assessed by the Questionnaire Developed by the Study Team	0.16 score on a scale Standard Deviation 0.305	0.714 score on a scale Standard Deviation 0.428

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Control n=121 Participants Group getting standard treatment without script guided intervention in the preoperative period	Script Guided Intervention n=113 Participants Group getting script guided intervention during the preoperative conversation Script guided conversation: Patients getting script guided intervention of 3 domains in the preoperative period
Number of Participants Satisfied With Anesthesia Conversation Satisfied	118 Participants	113 Participants
Number of Participants Satisfied With Anesthesia Conversation Neutral	3 Participants	0 Participants
Number of Participants Satisfied With Anesthesia Conversation Not satisfied	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Control n=121 Participants Group getting standard treatment without script guided intervention in the preoperative period	Script Guided Intervention n=113 Participants Group getting script guided intervention during the preoperative conversation Script guided conversation: Patients getting script guided intervention of 3 domains in the preoperative period
Preoperative Anxiety as Assessed by Questionnaire Developed by Study Team	3.33 score on a scale Standard Deviation 0.793	3.70 score on a scale Standard Deviation 0.938

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Script Guided Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Associate Professor

Johns Hopkins

Phone: 4109552611

Email: jsampso4@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place