Expanded Preoperative Survey During Perioperative Care to Identify Substance Use in Teenagers and Adolescents
Conditions: Anesthesia
Sponsor: Nationwide Children's Hospital

 
 
Expanded Preoperative Survey during Perioperative Care to Identify Substance 
Use in Teenagers and Adolescents 
 
 
NCT05353036 
 
 
March 16, 2022 

NATIONWIDE CHILDREN’S HOSPITAL 
SHORT PROTOCOL (Waiver of Consent or Verbal Consent) 
 
PROTOCOL TITLE:  Survey to Identify Substance Use in Teenagers and Adolescents 
 
 
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HRP-580  v.04.17.19 
PROTOCOL TITLE: 
Expanded Preoperative Survey during Perioperative Care to Identify Substance Use in 
Teenagers and Adolescents 
 
PRINCIPAL INVESTIGATOR: 
Joseph D. Tobias, MD 
Department of Anesthesiology & Pain Medicine 
614-722-4200 
Joseph.Tobias@nationwidechildrens.org 
 
VERSION NUMBER/DATE: 
Ver. 2/March 16, 2022 
 
Revision History 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
1 
3/16/2022 
Changing written consent to verbal in 5.4 & 
12.3, clarifying what will be collected in 9.4 & 
9.5, removing dates & MRN from 15.1, 
changing to HIPPAA authorization waiver in 
15.2, clarification in 15.4 & 15.5. 
Yes 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

NATIONWIDE CHILDREN’S HOSPITAL 
SHORT PROTOCOL (Waiver of Consent or Verbal Consent) 
 
PROTOCOL TITLE:  Survey to Identify Substance Use in Teenagers and Adolescents 
 
 
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HRP-580  v.04.17.19 
 
1.0 
 Study Summary  
 
Study Title 
Expanded Preoperative Survey during Perioperative Care to 
Identify Substance Use in Teenagers and Adolescents 
Study Design 
Patient survey  
Primary Objective 
To determine the incidence of illicit substance use and abuse 
prior to anesthetic care 
Secondary 
Objective(s) 
To determine the illicit substances used and their frequency 
in patients presenting for anesthetic care 
Study Population 
Patients 12-21 years of age presenting for anesthetic care 
Sample Size 
1000 
Study Duration  
3 years 
 
2.0  Methods 
2.1 Substance use disorders (SUD) and related psychopathology are 
persistent public health problems with over 20.3 million adults and 
1.3 million children in the U.S. estimated to have a SUD.  
Worldwide, there are over 3.4 billion illicit drug users, accounting 
for more than 10% of all deaths each year. Drug overdose, mostly 
linked to opioids, is the leading cause of unintentional injury deaths 
in the United States. An estimated 2 million Americans ≥ 12 years of 
age 12 have had an opioid use disorder involving prescription 
opioids, and approximately 600,000 have had an opioid use disorder 
involving heroin. The number of overdose deaths from illicit opioids 
tripled from 2011 to 2015 in the United States and sadly has crossed 
100,000 victims just this year.  The consequences of substance use 
costs the United States more than $600 billion every year. 
2.2 Illicit substance use is often initiated during adolescence with reports 
suggesting that more than 80% of drug users began using during 
adolescence. Unfortunately, only about 11% of individuals ≥ 12 of 
age and only 6% of adolescents who need treatment for substance 
abuse receive it. Additionally, more than half of the adolescents 
receiving treatment will relapse within one year of treatment, 
suggesting more accessible and effective programs are needed to 
prevent and treat substance use in adolescents.  The initial step in 
decreasing the impact of substance abuse is identification of those 
who are using followed by effective programs to deal with these 
problems. 
2.3 In addition to acute and chronic issues associated with substance 
abuse, these medications and substances can impact the perioperative 
care of patients and interact with anesthetic agents.  Preoperative 

NATIONWIDE CHILDREN’S HOSPITAL 
SHORT PROTOCOL (Waiver of Consent or Verbal Consent) 
 
PROTOCOL TITLE:  Survey to Identify Substance Use in Teenagers and Adolescents 
 
 
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HRP-580  v.04.17.19 
screening for these issues is now undertaken by an on-line 
preoperative questionnaire sent to the parents to complete prior to 
anesthetic care. Given the nature of such concerns and these issues, it 
is likely that there is under-reporting of these problems for various 
reasons. 
2.4 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. 
2.5 The participants will be asked to complete a survey in REDCap 
using an iPad during the visit. We 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. 
2.6 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. 
Explanation of the study, its confidentiality, and the purpose will 
take approximately 5-10 minutes. 
3.0 Data Banking 
3.1 All data collected during this study will be stored in a secure location, 
and only the collaborators directly involved with this research project 
will have access to this information. In addition, all electronic files 
will be stored on a secure, password-protected network.  
3.2 Data will be stored for 6 years after the study is completed. 
3.3 Data will not be stored for future use. 
4.0  Inclusion and Exclusion Criteria 
4.1 Inclusion: Patients 12-21 years of age presenting for surgery or procedure 
requiring anesthesia. 
4.2 Exclusion: Patients who are not able cognitively to complete the 
computerized survey due to physical or intellectual impairment or 
communication issues related to non-English speaking patients.   
5.0 Vulnerable Populations 
5.1 This research involves children but does not involve greater than minimal 
risk under 21 CFR §50.51/45 CFR §46.404.  
5.2 All data collected during this study will be stored in a secure location, and 
only the collaborators directly involved with this research project will have 

NATIONWIDE CHILDREN’S HOSPITAL 
SHORT PROTOCOL (Waiver of Consent or Verbal Consent) 
 
PROTOCOL TITLE:  Survey to Identify Substance Use in Teenagers and Adolescents 
 
 
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HRP-580  v.04.17.19 
access to this information. In addition, all electronic files will be stored on a 
secure, password-protected network.  
5.3 The subjects will not be exposed to greater than minimal risk. 
5.4 Parents/legal guardians will be asked to give verbal consent and children 
will provide assent.  
 
6.0 Number of Subjects (Records) 
6.1 1000.  
7.0 Recruitment Methods 
7.1 Patients will be identified using the operating room schedule. The 
study coordinator, PI, or sub-investigators will screen and identify 
appropriate participants. Screening participants will occur according 
to the protocol defined inclusion and exclusion criteria under the 
auspices of a partial waiver in accordance with the HIPAA privacy 
rule.  
7.2 Potential subjects will be approached in the pre-op area on the day of 
surgery by a member of the research team.  The study will be 
explained to the patient and parents/guardians and they will be 
provided a copy of the consent form to review. 
8.0 Withdrawal of Subjects 
8.1 Patients may withdraw from the study at any time.  
8.2 There are no anticipated circumstances under which subjects will be 
withdrawn from the research without their consent. 
9.0 Data Management and Confidentiality 
9.1 All data collected during this study will be stored in secure password 
protected computer files to which only trained members of the 
research team and collaborators directly involved with this research 
project will have access.  
9.2 The data will be stored for the duration of the study and retained for 
6 years after the study is completed per NCH as this meets both 
HIPAA and OHRP regulations.  
9.3 No data will be transmitted to or from external institutions.  
9.4 Subjects will be assigned a study identification number and no 
identifiers will be entered into REDCap.  Names and MRNs will not 
be recorded. 
9.5 The subject’s survey answers will not be looked at until the time of 
analysis at the end of the study. 
10.0 
Provisions to Protect the Privacy Interests of Subjects 

NATIONWIDE CHILDREN’S HOSPITAL 
SHORT PROTOCOL (Waiver of Consent or Verbal Consent) 
 
PROTOCOL TITLE:  Survey to Identify Substance Use in Teenagers and Adolescents 
 
 
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HRP-580  v.04.17.19 
10.1 Subject information will not be given to any other investigators. 
Subjects and their information will be closely monitored and guarded 
by study staff; there will be limited access to patients and their 
information by trained study staff; and subject information will only 
be shared and discussed between study staff specific to this study. 
10.2 Only the absolute minimum information necessary for this study will 
be collected from the patient’s records. Access to the patients’ charts 
will be limited to only the research team who have completed all the 
necessary training.  
10.3 We will only be publishing de-identified research information.  
11.0 
Economic Burden to Subjects 
11.1 There will be no costs to subjects and subjects will not receive any 
compensation. 
12.0 
Consent Process 
12.1 The consent process will begin in the preoperative surgery unit on 
the day of surgery, by PI, Sub­Investigators, Study Coordinators, 
and/or trained research staff.  
12.2 The study will be thoroughly explained to the patient and their 
family. There will be ample time allotted for questions and answers. 
An explanation of voluntary participation will take place, and the 
family will be asked if they are interested in participating in the 
study. The patient will then be enrolled in the study with the 
understanding that they can elect to stop the study and be withdrawn 
from the study at any time. 
12.3 Potential subjects will be provided a written information sheet and verbal 
consent will be obtained. 
13.0 
Setting 
13.1 Potential subjects will be identified from the surgery schedule in Epic and 
recruited from the pre-op area of the surgery unit.  Surveys will be 
completed via REDCap on iPads in the pre-op area.  
14.0 
Resources Available 
14.1 The research team is comprised of a PhD research scientist, a research 
nurse, a research coordinator, and two research associates. All team 
members will meet with the PI, co-investigators, and the research team for a 
study start up meeting for training about the protocol, research procedures, 
and their duties and functions. 
15.0 
Protected Health Information Recording 
 
1.0 
Indicate which subject identifiers will be recorded for this research. 

NATIONWIDE CHILDREN’S HOSPITAL 
SHORT PROTOCOL (Waiver of Consent or Verbal Consent) 
 
PROTOCOL TITLE:  Survey to Identify Substance Use in Teenagers and Adolescents 
 
 
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HRP-580  v.04.17.19 
☐  Name 
☒  Complete Address 
☐  Telephone or Fax Number 
☐  Social Security Number (do not check if only used for ClinCard) 
☐  Dates (treatment dates, birth date, date of death) 
☐  Email address , IP address or url 
☐  Medical Record Number or other account number 
☐  Health Plan Beneficiary Identification Number 
☐  Full face photographic images and/or any comparable images (x-rays) 
☐  Account Numbers 
☐  Certificate/License Numbers 
☐  Vehicle Identifiers and Serial Numbers (e.g. VINs, License Plate Numbers) 
☐  Device Identifiers and Serial Numbers 
☐  Biometric identifiers, including finger and voice prints 
☐  Other number, characteristic or code that could be used to identify an 
individual 
☐  None (Complete De-identification Certification Form) 
 
2.0   
Check the appropriate category and attach the required form* on the Local 
Site Documents, #3. Other Documents, page of the application.  (Choose one.) 
☐  Patient Authorization will be obtained. (Include the appropriate HIPAA 
language (see Section 14 of consent template) in the consent form OR attach 
the HRP-900, HIPAA AUTHORIZATION form.) 
☒  Protocol meets the criteria for waiver of authorization. (Attach the HRP-901, 
WAIVER OF HIPAA AUTHORIZATION REQUEST form.) 
☐  Protocol is using de-identified information. (Attach the HRP-902, DE-
IDENTIFICATION CERTIFICATION form.) (Checked "None" in 1.0 above) 
☐  Protocol involves research on decedents. (Attach the HRP-903, RESEARCH 
ON DECEDENTS REQUEST form.) 
☐  Protocol is using a limited data set and data use agreement. (Contact the 
Office of Technology Commercialization to initiate a Limited Data Use 
Agreement. 
 
*Find the HIPAA forms in the IRB Website Library, Templates. 
 
Attach the appropriate HIPAA form on the “Local Site Documents, #3. Other 
Documents”, page of the application. 
 
3.0    How long will identifying information on each participant be maintained? 
Identifying information on each participant will be retained for 6 years after the 
research is complete which meets both HIPAA and OHRP regulations. 

NATIONWIDE CHILDREN’S HOSPITAL 
SHORT PROTOCOL (Waiver of Consent or Verbal Consent) 
 
PROTOCOL TITLE:  Survey to Identify Substance Use in Teenagers and Adolescents 
 
 
Page 7 of 8 
HRP-580  v.04.17.19 
 
4.0 
Describe any plans to code identifiable information collected about each 
participant. Subjects will be assigned a study identification number and no 
identifiers will be entered into REDCap.  Names and MRNs will not be recorded. 
 
5.0 
Check each box that describes steps that will be taken to safeguard the 
confidentiality of information collected for this research: 
☒ Research records will be stored in a locked cabinet in a secure location 
☒ Research records will be stored in a password-protected computer file 
☐ The list linking the assigned code number to the individual subject will be 
maintained separately from the other research data 
☒ Only certified research personnel will be given access to identifiable 
subject information 
 
6.0 
Describe the provisions included in the protocol to protect the privacy     
interests of subjects, where "privacy interests" refer to the interest of 
individuals in being left alone, limiting access to them, and limiting access to 
their information. (This is not the same provision to maintain the 
confidentiality of data.)  Subject information will not be given to any other 
investigators. Subjects and their information will be closely monitored and 
guarded by study staff; there will be limited access to patients and their 
information by trained study staff; and subject information will only be shared 
and discussed between study staff specific to this study 
 
Confidential Health Information 
 
1.0 
Please mark all categories that reflect the nature of health information to be 
accessed and used as part of this research. 
 
☒  Demographics (age, gender, educational level) 
☐  Diagnosis 
☐  Laboratory reports 
☐  Radiology reports 
☐  Discharge summaries 
☐  Procedures/Treatments received 
☐  Dates related to course of treatment (admission, surgery, discharge) 
☐  Billing information 
☐  Names of drugs and/or devices used as part of treatment 
☐  Location of treatment 
☐  Name of treatment provider 
☐  Surgical reports 
☐  Other information related to course of treatment 

NATIONWIDE CHILDREN’S HOSPITAL 
SHORT PROTOCOL (Waiver of Consent or Verbal Consent) 
 
PROTOCOL TITLE:  Survey to Identify Substance Use in Teenagers and Adolescents 
 
 
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HRP-580  v.04.17.19 
☐  None 
 
2.0 
Please discuss why it is necessary to access and review the health information 
noted in your response above.  
It is necessary to review the above health information to enable us to describe our 
patient population, ensure they meet the study inclusion specifications and 
evaluate our study outcomes. 
 
3.0 
Is the health information to be accessed and reviewed the minimal necessary 
to achieve the goals of this research?  ☒ Yes    ☐ No 
 
4.0 
Will it be necessary to record information of a sensitive nature?  ☒ Yes  ☐ No 
 
5.0 
Do you plan to obtain a federally-issued Certificate of Confidentiality as a 
means of protecting the confidentiality of the information collected?  ☐ Yes   
☒ No