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This is a prospective survey study of patients 12-21 years undergoing anesthetic care. The primary objective is to determine the incidence of illicit substance use and abuse prior to anesthetic care. The secondary objective is to determine the illicit substances used and their frequency in patients presenting for anesthetic care.
The participants will be asked to complete a survey in REDCap using an iPad during the visit. The study will record any positive answers from the drug and tobacco use questions routinely asked of the parents during the on-line pre-admission testing process. These include yes/no answers regarding drug, alcohol, and tobacco use.
The information collected will include only demographic data including age, weight, gender, ethnicity/race, and zip code. Survey data will be coded and will not include patient information. Completion of the survey will take approximately 15-20 minutes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adolescents | Patients 12-21 years undergoing anesthetic care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Survey | Other | Survey assessing incidence, frequency, and type of illicit substance use |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adolescent and Parent Reported Alcohol, Drug, Vaping and Tobacco Usage | As part of standard of care, nurses contact the parents of children scheduled for surgery to obtain health history and any alcohol, drug, vaping and tobacco usage. For the study, adolescents were asked to complete a survey on REDCap regarding their alcohol, drug, vaping and tobacco usage and those responses were compared to the answers the parents gave to the nurses during pre-op phone call. | Baseline |
| Alcohol Use | Adolescents were asked in a REDCap survey Do you currently or have you ever drank alcohol? | Baseline |
| Marijuana Use | Adolescents were asked in a REDCap survey Do you currently or have you ever smoked or consumed marijuana, THC, or cannabis? | Baseline |
| Vape Pen Use | Adolescents were asked in a REDCap survey Do you currently or have you ever vaped? | Baseline |
| Tobacco Use | Adolescents were asked in a REDCap survey Do you currently or have you ever used tobacco? | Baseline |
| Prescription Opioid Use for Acute Pain | Adolescents were asked in a REDCap survey Do you currently or have you ever used a prescribed opioid for acute pain? | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Most Recent Alcohol Use | Adolescents were asked in a REDCap survey When was the last time you used alcohol? | Baseline |
| Age First Drank Alcohol | Adolescents were asked in a REDCap survey How old were you when you first drank alcohol? |
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Inclusion Criteria:
Exclusion Criteria:
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Adolescents undergoing procedure requiring anesthesia at Nationwide Children's Hospital.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Adolescents | Patients 12-21 years undergoing anesthetic care Survey: REDCap survey assessing incidence, frequency, and type of illicit substance use |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adolescents | Patients 12-21 years undergoing anesthetic care Survey: Survey assessing incidence, frequency, and type of illicit substance use |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 With Adolescent and Parent Reported Alcohol, Drug, Vaping and Tobacco Usage | As part of standard of care, nurses contact the parents of children scheduled for surgery to obtain health history and any alcohol, drug, vaping and tobacco usage. For the study, adolescents were asked to complete a survey on REDCap regarding their alcohol, drug, vaping and tobacco usage and those responses were compared to the answers the parents gave to the nurses during pre-op phone call. | Posted | Count of Participants | Participants | Baseline |
|
1 day
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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 | Adolescents | Patients 12-21 years undergoing anesthetic care Survey: Survey assessing incidence, frequency, and type of illicit substance use |
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One of the limitations of this study is the fact that data were only collected during the summer months. It is possible that these data would differ if collected throughout the school year. Additionally, the surveys were collected from patients undergoing prescheduled surgical procedures. Due to the rapid nature of urgent or emergent cases, inclusion of these patients in the study cohort was not deemed feasible.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joseph D. Tobias | Nationwide Children's Hospital | 614-722-4200 | joseph.tobias@nationwidechildrens.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 16, 2022 | Jun 5, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 16, 2022 | Jun 5, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Baseline |
| Most Recent Marijuana Use | Adolescents were asked in a REDCap survey When was the last time you used marijuana? | Baseline |
| Age First Used Marijuana | Adolescents were asked in a REDCap survey How old were you when you first started using? | Baseline |
| Most Recent Vape Pen Use | Adolescents were asked in a REDCap survey When was the last time you vaped? | Baseline |
| Age First Started Vaping | Adolescents were asked in a REDCap survey How old were you when you first started vaping? | Baseline |
| Most Recent Tobacco Use | Adolescents were asked in a REDCap survey When was the last time you used tobacco? | Baseline |
| Age First Used Tobacco | Adolescents were asked in a REDCap survey How old were you when you started using tobacco? | Baseline |
| Most Recent Prescribed Opioid Use | Adolescents were asked in a REDCap survey When was the last time you used a prescribed opioid for acute pain? | Baseline |
| Prescribed Opioid Use for Anything Other Than Pain | Adolescents were asked in a REDCap survey Did you ever use that medication (prescribed opioid) for anything other than pain? | Baseline |
| Prescribed Opioid Use Leading to Abuse | Adolescents were asked in a REDCap survey Did your using prescribed opioid for anything other than pain lead to your abusing opioids/narcotics? | Baseline |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Parents | Parents of the adolescent participants |
|
|
| Primary | Alcohol Use | Adolescents were asked in a REDCap survey Do you currently or have you ever drank alcohol? | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Primary | Marijuana Use | Adolescents were asked in a REDCap survey Do you currently or have you ever smoked or consumed marijuana, THC, or cannabis? | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Primary | Vape Pen Use | Adolescents were asked in a REDCap survey Do you currently or have you ever vaped? | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Primary | Tobacco Use | Adolescents were asked in a REDCap survey Do you currently or have you ever used tobacco? | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Primary | Prescription Opioid Use for Acute Pain | Adolescents were asked in a REDCap survey Do you currently or have you ever used a prescribed opioid for acute pain? | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Most Recent Alcohol Use | Adolescents were asked in a REDCap survey When was the last time you used alcohol? | The number of participants that answered yes to the currently or ever used alcohol question. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Age First Drank Alcohol | Adolescents were asked in a REDCap survey How old were you when you first drank alcohol? | The number of participants that answered yes to the currently or ever drank alcohol question. | Posted | Median | Inter-Quartile Range | years | Baseline |
|
|
|
| Secondary | Most Recent Marijuana Use | Adolescents were asked in a REDCap survey When was the last time you used marijuana? | The number of participants that answered yes to the currently or ever used marijuana question. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Age First Used Marijuana | Adolescents were asked in a REDCap survey How old were you when you first started using? | The number of participants that answered yes to the currently or ever used marijuana question. | Posted | Median | Inter-Quartile Range | years | Baseline |
|
|
|
| Secondary | Most Recent Vape Pen Use | Adolescents were asked in a REDCap survey When was the last time you vaped? | The number of participants that answered yes to the currently or ever used vape pen question. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Age First Started Vaping | Adolescents were asked in a REDCap survey How old were you when you first started vaping? | The number of participants that answered yes to the currently or ever vaped question. | Posted | Median | Inter-Quartile Range | years | Baseline |
|
|
|
| Secondary | Most Recent Tobacco Use | Adolescents were asked in a REDCap survey When was the last time you used tobacco? | The number of participants that answered yes to the currently or ever used tobacco question. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Age First Used Tobacco | Adolescents were asked in a REDCap survey How old were you when you started using tobacco? | The number of participants that answered yes to the currently or ever used tobacco question. | Posted | Median | Inter-Quartile Range | years | Baseline |
|
|
|
| Secondary | Most Recent Prescribed Opioid Use | Adolescents were asked in a REDCap survey When was the last time you used a prescribed opioid for acute pain? | The number of participants that answered yes to the currently or have ever used a prescribed opioid for acute pain question. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Prescribed Opioid Use for Anything Other Than Pain | Adolescents were asked in a REDCap survey Did you ever use that medication (prescribed opioid) for anything other than pain? | The number of participants that answered yes to the currently or ever used prescribed opioid for acute pain question. | Posted | Count of Participants | Participants | Baseline |
|
|
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| Secondary | Prescribed Opioid Use Leading to Abuse | Adolescents were asked in a REDCap survey Did your using prescribed opioid for anything other than pain lead to your abusing opioids/narcotics? | The number of participants that answered yes to the currently or ever used prescribed opioid for acute pain question. | Posted | Count of Participants | Participants | Baseline |
|
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| 0 |
| 250 |
| 0 |
| 250 |
| 0 |
| 250 |
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| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| Title |
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| Measurements |
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| Within the last year |
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| Title | Measurements |
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| Within the last year |
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| Title |
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| Measurements |
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| Within the last year |
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| Title |
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| Measurements |
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| Within the last year |
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| Title | Measurements |
|---|---|
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| Within the last year |
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| No answer |
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