CommunicationACCPNCT06010836
Anesthesia Counseling, Consent, & Professionalism
A study testing Script guided conversation in people with Communication and Preoperative, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Communication, Preoperative, Ethics
- What is being tested?
- Script guided conversation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 257 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 and up
- Elective Procedures
- English-speaking
- Consenting for general anesthesia
Who cannot join
- Obstetric patients
- Prisoners
- Emergency cases
- Patients under age 18
- Patients don't speak English
- Not consented for general anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anesthesiology 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.
Read the 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.
- Conditions
- Communication, Preoperative, Ethics
- Being tested
- Script guided conversation
- Keywords
- Communication, Medical ethics, Professionalism
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Script guided conversationBehavioural
Patients getting script guided intervention of 3 domains in the preoperative period
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Script guided conversation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: up to 3 days after surgery
Secondary outcomes (2)
Number of Participants Satisfied With Anesthesia Conversation
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)
Measured: up to three days after surgery
Preoperative Anxiety as Assessed by Questionnaire Developed by Study Team
Patients are asked about any change in anxiety after the preoperative conversation using likert scale extremely reduced (5) to extremely more anxious (1)
Measured: up to 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start1 Nov 2021
- Primary completion17 Nov 2022
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CommunicationStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Sampson, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06010836
- Sponsor's protocol ID
- IRB00268333
- Acronym
- ACCP
- Status last verified
- Jun 2026
- First submitted
- 29 May 2023
- Last updated
- 8 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: None to be shared
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthesiology Counseling, Consent, & Professionalism
- ClinicalTrials.gov ID
- NCT06010836
- Acronym / sponsor ID
- ACCP / IRB00268333
- Conditions
- Communication, Preoperative, Ethics
- Keywords
- Communication, Medical ethics, Professionalism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 17 Nov 2022 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 25 Aug 2023 (actual)
- Results
- Posted 20 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Group getting standard treatment without script guided intervention in the preoperative period |
| Script guided intervention | Experimental | Behavioral: Script guided conversationGroup getting script guided intervention during the preoperative conversation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 and up
- Elective Procedures
- English-speaking
- Consenting for general anesthesia
Key exclusion criteria (6 listed)
- Obstetric patients
- Prisoners
- Emergency cases
- Patients under age 18
- Patients don't speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Script guided conversationPatients getting script guided intervention of 3 domains in the preoperative period | Behavioural | Script guided intervention |
Primary outcome
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.
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
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.
2 secondary outcomes
Number of Participants Satisfied With Anesthesia Conversation
Time frame: up to three days after surgery
Preoperative Anxiety as Assessed by Questionnaire Developed by Study Team
Time frame: up to 3 days after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. None to be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Sampson, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Script guided conversation in people with Communication and Preoperative, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Recall Anesthesia Team Members (time frame: up to 3 days after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026; AzTrials last refreshed its copy on 30 Oct 2026.