Application of Behavioral Economic Strategies to Enhance Recruitment Into a Pediatric Randomized Clinical Trial
Phase: NA
Conditions: Surgery, Adolescent Behavior
Sponsor: Vanessa Olbrecht

 
Application of behavioral economic strategies to enhance recruitment into a 
pediatric randomized clinical trial 
 
 
NCT05441579 
 
 
May 6, 2022 

NATIONWIDE CHILDREN’S HOSPITAL 
SHORT PROTOCOL (Waiver of Consent or Verbal Consent) 
 
PROTOCOL TITLE:  Recruitment and behavioral economic strategies 
 
 
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HRP-580  v.04.17.19 
PROTOCOL TITLE: 
Application of behavioral economic strategies to enhance recruitment into a pediatric 
randomized clinical trial 
 
PRINCIPAL INVESTIGATOR: 
Vanessa A. Olbrecht, MD, MBA 
Department of Anesthesiology & Pain Medicine 
614-722-4200 
Vanessa.Olbrecht@nationwidechildrens.org 
 
VERSION NUMBER/DATE: 
Ver. 1.0 / January 19, 2022 
 
Revision History 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

NATIONWIDE CHILDREN’S HOSPITAL 
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PROTOCOL TITLE:  Recruitment and behavioral economic strategies 
 
 
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1.0 
 Study Summary  
 
Study Title 
Application of behavioral economic strategies to enhance 
recruitment into a pediatric randomized clinical trial 
Study Design 
Prospective, randomized, double-blind clinical trial 
Primary Objective 
To determine the impact of the application of behavioral 
economic strategies on recruitment of pediatric patients into 
a randomized clinical trial assessing the impact of 
technology-based interventions on postoperative pain 
management 
Secondary 
Objective(s) 
N/A 
Study Population 
Patients 12-18 years of age presenting for surgery that 
requires postoperative admission and usually requires 
narcotic administration. 
Sample Size 
800 
Study Duration  
3 years 
 
2.0  Methods 
2.1 One of the largest challenges faced in clinical trials is patient 
recruitment. It is often associated with one of the largest costs of the 
trial and inability to enroll in a clinical trial can ultimately result in 
under-enrollment and failure of the trial to yield results.1 According 
to data from the Institute of Medicine, more than 40% of National 
Cancer Institute-sponsored clinical trials do not reach the minimal 
accrual of patients when enrollment closes due to challenges with 
recruitment.2 Underpowering studies because of enrollment 
difficulties will result in clinical trials that are not appropriately 
powered to answer the initial hypothesis, often resulting in 
participants being exposed to the risks associated with a clinical trial 
without any actual benefit.3 Furthermore, challenges with 
recruitment may result in a very homogeneous study population, 
resulting in difficulty in applying results of a study to a larger, 
broader population.1 Over time, many strategies have been 
attempted to help enhance clinical trial enrollment, including 
offering financial incentives.4 Financial incentives, however, may 
not be the best way to enhance enrollment as high financial 
incentives are often perceived to be associated with high risk and 
there are ethical concerns about payments made to subjects.5  
2.2 Despite plaguing clinical trials, there are not many strategies that 
have effectively been shown to increase recruitment and enrollment 
into clinical trials.6 A recent meta-analysis attempted to identify 

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PROTOCOL TITLE:  Recruitment and behavioral economic strategies 
 
 
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strategies to improve recruitment into trials. Of the 72 strategies 
assessed in the literature, only two showed some benefit: Using open 
trials rather than blinded, placebo trials; and using telephone 
reminders to people who do not respond to a mailed invitation.6 The 
first is obviously contrary to the goal of a study and may influence 
its results and the second showed a very modest improvement of 
only 6% (95% CI 3% to 9%). As such, no clear strategies currently 
exist.  
2.3 Behavioral economics (BE), a method of economic analysis that 
applies psychological insights into human behavior to explain 
economic decision-making, has broad applicability and its 
techniques offer a novel way that may be applied to try to help 
enhance study recruitment and enrollment. While many often assume 
that BE relates to how to optimize use of financial incentives and 
penalties, BE strategies can also provide insight into messaging and 
presentation of information, such as recruitment for clinical trials. 
Few studies have assessed the use of BE techniques for clinical trial 
recruitment and enrollment, including “nudges” and framing, to help 
enhance patient enrollment.1,7,8 To our knowledge, this type of study 
has never been done in a pediatric population, which increases the 
complexity of enrollment as patients themselves are often not the 
ones consenting to participate and not only do the participants need 
to be convinced to participate but also their parent(s).6 We are 
applying BE-based messaging and presentation strategies to patient 
recruitment and determining whether these strategies may enhance 
patient recruitment into a pediatric randomized clinical trial. We are 
looking at recruitment into both the intervention (VR-BF) as well as 
control (Manage My Pain) arm because in order for a trial to be 
successful, you must be able to successfully recruit not only into the 
intervention arm, but also into the control arm.  
2.4 The goal of this study is to determine the impact of using a BE-
informed recruitment video versus a similar recruitment video using 
a standard biological approach on teenagers’ decision to enroll in a 
clinical study assessing the use of technology-based interventions to 
improve postoperative pain management into both the intervention 
as well as control arm. We will also assess the impact of the BE-
informed script on the intention to adhere to the treatment, 
acceptability of the intervention, and perception of treatment burden, 
risk, and perceived efficacy assessed via patient survey. We 
hypothesize that using the BE-informed approach will enhance 
enrollment as well as the intention to adhere to treatment, 
acceptability of the intervention, and perceived efficacy while 
decreasing the perception of treatment burden and risk.    

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2.5 This is a single center, prospective, randomized, double-blinded 
clinical trial that will be conducted in two stages. Phase 1 will focus 
on patients that would be enrolled into a biofeedback-based virtual 
reality (VR-BF) arm and Phase 2 will focus on patients that would 
be enrolled into the control arm of a clinical trial with a control 
intervention, Manage My Pain application. Prior to beginning 
recruitment in Phase 1, we will create a script and film the videos 
associated with those scripts. Information learned in Phase 1 may 
result in slight modifications of the script and videos.  
2.6 Patients will be identified prior to surgery by assessing the operating 
room schedule after being booked for surgery. In Phase 1, for the 
VR-BF intervention, patients and parents will be approached and 
asked if they would like to hear about an upcoming study with a 
technology that is under development but not yet available but that 
we would like to obtain their feedback as the study will involve 
patients having surgery similar to the one that he/she is undergoing. 
Although the literature suggests that patients should not be told that 
this is a hypothetical study to avoid bias (“self-prophecy”) associated 
with telling them they do not have the opportunity to participate in 
the study,1,7 it would be unethical in this situation to tell a family 
about a study that would potentially be of interest and then tell them 
that the patient is not eligible as the study does not exist, particularly 
in the stressful setting they are. However, to minimize social 
desirability bias, they will be explicitly be informed that the survey 
is one-time and anonymous and that answers/opinions will not 
impact clinical care in any capacity. In addition, the survey will be 
done on paper and placed by the patient into a collection box with 
other papers/surveys, emphasizing the anonymity of results and 
avoiding things like time stamps on electronic records that may 
make anonymity less believable to the patient and family. Patients in 
Phase 1 will be randomized to 1 of 2 groups: VR-BF recruitment 
video using a BE-based script and one using a standard biological 
approach. A total of 400 patients, 200 per group, will be recruited in 
this phase. Following agreement to participate and consent, subjects 
will be shown 1 of the 2 recruitment videos based upon 
randomization and then given a standardized survey assessing the 
decision to enroll and other components of acceptability. 
2.7 The process for Phase 2 will be the same as Phase 1 with the 
exception of how the families are approached. Because Manage My 
Pain is commercially available and free on the app store (iOS and 
Android platforms), patients and families will be asked if they would 
like to hear about an upcoming study being offered to patients 
having surgery similar to the one that their child is undergoing. They 

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PROTOCOL TITLE:  Recruitment and behavioral economic strategies 
 
 
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will not explicitly be told that this is a hypothetical study to avoid the 
“self-prophecy” bias1,7 but, in order to avoid disappointment and the 
ethical concerns, they will be informed that they are free to 
download the application and use it if they so desire at the 
conclusion of the study visit.   
2.8 The surveys will not collect any data that may identify the patient to 
remain anonymous. 
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 between the ages of 12-18 years of age  
• Patients able to read, understand, and speak English 
• Patients undergoing surgery requiring postoperative admission 
• Patients undergoing surgery that requires narcotic administration 
4.2 Exclusion:  
• Patients outside of the age range 
• Patients with history of developmental delay, uncontrolled 
psychiatric conditions, or neurological conditions (i.e., epilepsy, 
motion sickness, nausea/vomiting) 
• History of severe vertigo or dizziness 
• History of chronic pain 
• Patients that use opioids or benzodiazepines chronically 
• Patients with conditions that would preclude placement of a VR 
headset, including craniofacial abnormalities or undergoing surgeries 
of the head and neck.   
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 
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. 

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5.4 Parents/legal guardians will be asked to give verbal informed consent and 
children over the age of 9 years will provide verbal assent.  
 
6.0 Number of Subjects (Records) 
6.1 800.  
7.0 Recruitment Methods 
7.1 No recruitment materials will be used. Patients will be identified 
using the operating room schedule. The study coordinator, PI, or 
sub-investigators will screen and identify appropriate participants 
based on the operating room schedule’s noted location of their preop 
room. No names or other identifying information will be recorded. 
Screening participants will occur according to the protocol defined 
inclusion and exclusion criteria.   
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 (REDCap) and secure locked cabinets 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.   
10.0 
Provisions to Protect the Privacy Interests of Subjects 
10.1 With this being an anonymous survey, there will be nothing linking 
subjects to their survey responses. 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 No PHI will be recorded for this study from patient records. Access 
to the patients’ charts will be limited to only recruitment phase to 

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assess inclusion/exclusion criteria by 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 As this is a minimal risk study and only involves completing a 
survey, we are requesting a waiver of documentation of informed 
consent. To keep this study completely anonymous with no PHI 
collected, it would not be feasible to obtain a signed, written, 
consent.  
12.4 Potential subjects will be provided a written information sheet and 
verbal consent and assent 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 on paper in the pre-op area which will be collected and submitted 
into REDCap.  
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 
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☐  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? 
 

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We will access PHI for recruitment purposes only, there will be no recorded 
identifying information. Survey results will be retained for 6 years after the 
research is complete which meets both HIPAA and OHRP regulations. 
 
4.0 
Describe any plans to code identifiable information collected about each 
participant. Subjects surveys will be assigned a study identification number and 
no identifiers will be entered into REDCap. There is no identifying information 
being 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 

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☐  Location of treatment 
☐  Name of treatment provider 
☒  Surgical reports 
☒  Other information related to course of treatment 
☐  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 identify our 
patient population, ensure they meet the study inclusion and exclusion 
specifications. No confidential health information for use of recruitment will be 
recorded. 
 
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