Survey to Identify Substance Use in Teenagers and Adolescents

June 6, 2024 updated by: Joseph D. Tobias, Nationwide Children's Hospital

Expanded Preoperative Survey During Perioperative Care to Identify Substance Use in Teenagers and Adolescents

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adolescents undergoing procedure requiring anesthesia at Nationwide Children's Hospital.

Description

Inclusion Criteria:

  • Patients 12-21 years of age
  • Presenting for surgery or procedure requiring anesthesia

Exclusion Criteria:

  • Patients who are not able to complete the computerized survey due to physical or intellectual impairment
  • Patients who are non-English speaking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Adolescents
Patients 12-21 years undergoing anesthetic care
Other: Survey
Survey assessing incidence, frequency, and type of illicit substance use

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Adolescent and Parent Reported Alcohol, Drug, Vaping and Tobacco Usage
Time Frame: Baseline
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
Time Frame: Baseline
Adolescents were asked in a REDCap survey Do you currently or have you ever drank alcohol?
Baseline
Marijuana Use
Time Frame: Baseline
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
Time Frame: Baseline
Adolescents were asked in a REDCap survey Do you currently or have you ever vaped?
Baseline
Tobacco Use
Time Frame: Baseline
Adolescents were asked in a REDCap survey Do you currently or have you ever used tobacco?
Baseline
Prescription Opioid Use for Acute Pain
Time Frame: Baseline
Adolescents were asked in a REDCap survey Do you currently or have you ever used a prescribed opioid for acute pain?
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Most Recent Alcohol Use
Time Frame: Baseline
Adolescents were asked in a REDCap survey When was the last time you used alcohol?
Baseline
Age First Drank Alcohol
Time Frame: Baseline
Adolescents were asked in a REDCap survey How old were you when you first drank alcohol?
Baseline
Most Recent Marijuana Use
Time Frame: Baseline
Adolescents were asked in a REDCap survey When was the last time you used marijuana?
Baseline
Age First Used Marijuana
Time Frame: Baseline
Adolescents were asked in a REDCap survey How old were you when you first started using?
Baseline
Most Recent Vape Pen Use
Time Frame: Baseline
Adolescents were asked in a REDCap survey When was the last time you vaped?
Baseline
Age First Started Vaping
Time Frame: Baseline
Adolescents were asked in a REDCap survey How old were you when you first started vaping?
Baseline
Most Recent Tobacco Use
Time Frame: Baseline
Adolescents were asked in a REDCap survey When was the last time you used tobacco?
Baseline
Age First Used Tobacco
Time Frame: Baseline
Adolescents were asked in a REDCap survey How old were you when you started using tobacco?
Baseline
Most Recent Prescribed Opioid Use
Time Frame: Baseline
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
Time Frame: Baseline
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
Time Frame: Baseline
Adolescents were asked in a REDCap survey Did your using prescribed opioid for anything other than pain lead to your abusing opioids/narcotics?
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nationwide Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 27, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 25, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00002306

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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