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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Script guided conversation | Behavioral | Patients getting script guided intervention of 3 domains in the preoperative period |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | up to three days after surgery |
| Preoperative Anxiety as Assessed by Questionnaire Developed by Study Team |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Sampson, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
None to be shared
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Group getting standard treatment without script guided intervention in the preoperative period |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Reporting data for study completers. 234 participants completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Group getting standard treatment without script guided intervention in the preoperative period |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | up to 3 days after surgery |
|
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Adverse Events were not collected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Group getting standard treatment without script guided intervention in the preoperative period |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Professor | Johns Hopkins | 4109552611 | jsampso4@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 12, 2021 | Jan 16, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003142 | Communication |
| ID | Term |
|---|---|
| D001519 | Behavior |
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Patients are asked about any change in anxiety after the preoperative conversation using likert scale extremely reduced (5) to extremely more anxious (1) |
| up to 3 days after surgery |
| Poor or absent audio recording for data collection |
|
| Did not receive intervention discussion |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
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| Primary | Number of Participants Who Recall Anesthetic Risks | anesthesia risks, (0) don't remember any risks - (3) remembered 3 or more correctly | Posted | Count of Participants | Participants | up to 3 days after surgery |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | up to 3 days after surgery |
|
|
|
| Secondary | 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) | Posted | Count of Participants | Participants | up to three days after surgery |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | score on a scale | up to 3 days after surgery |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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 | 0 | 0 | 0 | 0 | 0 | 0 |
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| Recall 3 or more risks |
|
| No recall |
|
| Unknown |
|
| Not satisfied |
|