Communication, Ethics, Preoperative
Conditions
Keywords
Communication, Medical ethics, Professionalism
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.
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.
Interventions
BEHAVIORALScript guided conversation
Patients getting script guided intervention of 3 domains in the preoperative period
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Recall Anesthesia Team Members | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Satisfied With Anesthesia Conversation | 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) |
| 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) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJohn Sampson, MD
Johns Hopkins University
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group getting standard treatment without script guided intervention in the preoperative period | 121 |
| 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 | 113 |
| Total | 234 |
Baseline characteristics
| Characteristic | Control | Script Guided Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 34 Participants | 28 Participants | 62 Participants |
| Age, Categorical Between 18 and 65 years | 87 Participants | 85 Participants | 172 Participants |
| Age, Continuous | 58 years | 57 years | 57.5 years |
| Race/Ethnicity, Customized Asian | 4 Participants | 5 Participants | 9 Participants |
| Race/Ethnicity, Customized Black | 30 Participants | 25 Participants | 55 Participants |
| Race/Ethnicity, Customized Hispanic | 3 Participants | 5 Participants | 8 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 82 Participants | 77 Participants | 159 Participants |
| Region of Enrollment United States | 121 Participants | 113 Participants | 234 Participants |
| Sex: Female, Male Female | 78 Participants | 57 Participants | 135 Participants |
| Sex: Female, Male Male | 43 Participants | 56 Participants | 99 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: up to 3 days after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Participants Who Recall Anesthesia Team Members | 30 Participants |
| Script Guided Intervention | Number of Participants Who Recall Anesthesia Team Members | 49 Participants |
Primary
Number of Participants Who Recall Anesthetic Risks
anesthesia risks, (0) don't remember any risks - (3) remembered 3 or more correctly
Time frame: up to 3 days after surgery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Number of Participants Who Recall Anesthetic Risks | Unknown | 1 Participants |
| Control | Number of Participants Who Recall Anesthetic Risks | Recall 1 risk | 29 Participants |
| Control | Number of Participants Who Recall Anesthetic Risks | Recall 2 risks | 22 Participants |
| Control | Number of Participants Who Recall Anesthetic Risks | Recall 3 or more risks | 20 Participants |
| Control | Number of Participants Who Recall Anesthetic Risks | No recall | 49 Participants |
| Script Guided Intervention | Number of Participants Who Recall Anesthetic Risks | No recall | 19 Participants |
| Script Guided Intervention | Number of Participants Who Recall Anesthetic Risks | Recall 3 or more risks | 24 Participants |
| Script Guided Intervention | Number of Participants Who Recall Anesthetic Risks | Recall 1 risk | 34 Participants |
| Script Guided Intervention | Number of Participants Who Recall Anesthetic Risks | Unknown | 0 Participants |
| Script Guided Intervention | Number of Participants Who Recall Anesthetic Risks | Recall 2 risks | 36 Participants |
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.
Time frame: up to 3 days after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | 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 |
| Script Guided Intervention | Postoperative Understanding of Anesthetic Plan as Assessed by the Questionnaire Developed by the Study Team | 0.714 score on a scale | Standard Deviation 0.428 |
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)
Time frame: up to three days after surgery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Number of Participants Satisfied With Anesthesia Conversation | Satisfied | 118 Participants |
| Control | Number of Participants Satisfied With Anesthesia Conversation | Not satisfied | 0 Participants |
| Control | Number of Participants Satisfied With Anesthesia Conversation | Neutral | 3 Participants |
| Script Guided Intervention | Number of Participants Satisfied With Anesthesia Conversation | Satisfied | 113 Participants |
| Script Guided Intervention | Number of Participants Satisfied With Anesthesia Conversation | Not satisfied | 0 Participants |
| Script Guided Intervention | Number of Participants Satisfied With Anesthesia Conversation | Neutral | 0 Participants |
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)
Time frame: up to 3 days after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Preoperative Anxiety as Assessed by Questionnaire Developed by Study Team | 3.33 score on a scale | Standard Deviation 0.793 |
| Script Guided Intervention | Preoperative Anxiety as Assessed by Questionnaire Developed by Study Team | 3.70 score on a scale | Standard Deviation 0.938 |