Inability to Recruit Adolescents for a Vaping Cessation Clinical Trial Within a Large Pediatric Health System

Introduction

E-cigarette use among adolescents is epidemic, putting children at risk for significant harm.^1,2 E-cigarettes are the most commonly used tobacco product among youth, with over 20% of high school students reporting current use.³ Harmful toxicants and known carcinogens are found in the solutions, emissions, and bodies of e-cigarette users.⁴ The absence of evidence-based treatment recommendations for adolescent e-cigarette use indicates the need for research designed to identify effective interventions.⁵ Furthermore, few lessons learned from clinical trial research to treat adolescents for combustible tobacco products can be applied to e-cigarette research. Progress has been limited by difficulty identifying adolescents interested in treatment, enrolling them in trials, and maintaining treatment engagement.^6,7 A recent negative trial investigating varenicline use for adolescent cigarette cessation took 5 years to complete recruitment for a relatively small sample size (n = 157).⁸

Health information technology and electronic health record tools embedded within pediatric primary care networks may be a novel and effective way to enroll adolescent e-cigarette users into clinical trials. Adolescents view pediatricians, who see the majority of the US child and adolescent population,⁹ as trusted sources for health information. Consequently, pediatricians are uniquely positioned to implement systems to identify adolescent e-cigarette users and connect them to available clinical trials. Thus, as part of a pilot randomized controlled trial investigating the effects of financial incentives on increasing adolescent e-cigarette treatment engagement and cessation (clinicaltrials.gov, NCT03670264), we describe our experience leveraging a large pediatric health system to identify and recruit adolescent e-cigarette users.

Recruitment and Engagement

This trial tested three critical components: identification of eligible youth through a large pediatric healthcare system, study enrollment facilitation through a combination of electronic health record prompts and a confidential, secure text-messaging platform, and treatment engagement through a novel, youth-focused tobacco/vaping cessation program. Recruitment occurred through 25 practices within Children’s Hospital of Philadelphia’s (CHOP’s) Pediatric Research Consortium (PeRC), a primary care practice-based research network serving approximately 300 000 patients (53% White, 25% African American, 61% private insurance, and 34% Medicaid) at 29 urban, suburban, and semirural practices in Pennsylvania and New Jersey. For inclusion in the study, youth had to speak English, be between 14 and 21 years old, live in Pennsylvania, have a mobile phone, and screen positive for current tobacco/vaping use (use at least once during the past 30 days) during their routine well child visit or through a separate referral. The CHOP Institutional Review Board approved the study.

E-cigarette Screening Through Clinical Practice

We incorporated adolescent e-cigarette screening into routine clinical practice, embedded in the electronic health record (Epic). Clinicians were prompted to ask: “in the past year, have you used a tobacco product, like cigarettes, e-cigarettes (vaping devices such as tanks, mods, or Juul), or cigarillos (little cigars)?” If adolescents reported use, additional prompts asked about product use, frequency of use, and interest in treatment and referral to our study. We added additional recruitment approaches, highlighted below, through the length of the study.

Study Enrollment and Vaping Cessation Treatment

Adolescent e-cigarette users who were interested in treatment were approached through secure text-messaging via the Way to Health (WTH) platform.¹⁰ The platform handles bidirectional texting and surveys. Once enrolled, participants were connected with the My Life, My Quit program, a youth-specific quitline.

Outcomes and Analysis

We quantified patients who screened positive for e-cigarette/tobacco use in clinical practice, potential eligible subjects identified through other means, and those successfully enrolled in the study. Our originally planned primary outcome was e-cigarette user engagement with the cessation program (proportions who enrolled, used, and completed the program) compared across three arms: (1) incentives to use the quitline; (2) an incentive after a confirmed quit at the end of the study; or (3) no incentive. The sample size goal was 60 participants (20/arm).

Screening, Recruitment, and Enrollment Results

From May 2018 to August 2020, 93 527 adolescents had a well visit, and 66 907 adolescents were screened for tobacco/e-cigarette use. Of those screened, 1603 (2.4%) reported any past year tobacco/e-cigarette use and 537 (0.80%) reported current e-cigarette use. Rates of positive screens were low regardless of practice type (ie, urban, suburban, or semirural). Through clinical-based screening and recruitment, 47 adolescent e-cigarette users were referred (11.1% of current e-cigarette users). Referral rates did not increase despite (1) 4382 recruitment emails to CHOP’s research registry (a list of patients and parents interested in studies), ads on CHOP’s website and social media accounts, and additional advertisements, (2) recruitment materials posted around the health system sites, (3) expanding the age range for study eligibility (from 14–18 to 14–21), and (4) advertising and working with additional community partners on a local affiliated college campus. Five additional potential subjects were referred via these methods. Ultimately, 52 adolescent e-cigarette users were referred: 15 subjects enrolled, 18 potential participants could not be contacted, 14 were not interested, and 5 were ineligible. Of those enrolled in the trial, six participants enrolled in the cessation program.

Implications

Despite access to >93 000 adolescents and use of an integrated system for identifying and referring adolescent e-cigarette users, this was a failed feasibility pilot study. Only 2.4% of adolescents reported any e-cigarette/tobacco use—a stark contrast with the rates from school-based national estimates.³ Based on this analysis, adding e-cigarette screening prompts into the electronic health record for routine visit documentation templates alone may not identify youth e-cigarette users. Even in clinical practices that ensured privacy and confidentiality—meaning e-cigarette use questions were asked confidentially by the trusted provider, in a private setting, without the parent present—screening does not yield e-cigarette use rates reported elsewhere.³ Furthermore, adolescents did not engage in treatment even when we leveraged health information technology tools, a text-messaging platform to support recruitment engagement, and an easily accessed treatment program. Researchers committed to developing and implementing clinical trials to test interventions to reduce adolescent e-cigarette use may not be able to rely upon recruiting through pediatric health care networks to enroll their samples. Either new methods for screening and identifying adolescent e-cigarette users or broader national efforts may be needed to recruit for such trials.

Supplementary Material

A Contributorship Form detailing each author’s specific involvement with this content, as well as any supplementary data, are available online at https://academic.oup.com/ntr.

Funding

The work was supported in part by grant number UL1TR001878 from the National Center for Advancing Translational Science and award number K08CA226390 (Dr. Jenssen) by the National Cancer Institute. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Advancing Translational Science, the National Cancer Institute, or the National Institutes of Health. Supported in part by the Institute for Translational Medicine and Therapeutics’ (ITMAT).

Declaration of Interests

None declared.