Perspectives in Implementing a Pragmatic Pediatric Primary Care-Based Intervention Trial.

The 2013 U.S. Preventive Services Task Force (USPSTF) concluded that behavioral interventions are effective in reducing initiation of smoking in youth, recommending primary care clinicians provide education or brief counseling to prevent initiation, and that there are promising trends toward behavioral interventions improving cessation in this population. Our primary care-based intervention RCT conducted between 2000 and 2004, Air It Out, informed these USPSTF recommendations. Our trial was designed to determine whether a pediatric primary care practice-based smoking prevention and cessation intervention would be effective in increasing abstinence rates among adolescents under usual clinic conditions, to inform clinical practice. Therefore, the trial was designed to be largely a pragmatic trial. In this paper, we describe where each of the Air It Out study components falls along the pragmatic-explanatory continuum regarding participant eligibility criteria, intervention and comparison condition design, follow-up and outcomes, compliance and adherence assessments, and analysis. Such an assessment assists researchers by providing a framework to guide decisions regarding study design and implementation. We then share a few principles and lessons learned in developing and implementing the primary care-based intervention trial, focusing on study setting selection, engaging providers who will be delivering the intervention and the target population who will be receiving it in designing the trial and interventions to be tested, and the need to carefully plan recruitment and retention procedures. The hope is to increase the number of well-designed studies that can be included in the evidence reviews to guide future USPSTF recommendation statements.

Effect of a pediatric practice-based smoking prevention and cessation intervention for adolescents: a randomized, controlled trial.

OBJECTIVE: The purpose of this work was to determine whether a pediatric practice-based smoking prevention and cessation intervention increases abstinence rates among adolescents. METHODS: Eight pediatric primary care clinics were randomly assigned to either intervention or usual care control condition. The provider- and peer-delivered intervention tested was based on the 5A model recommended by the US Public Health Service clinical practice guidelines and the American Academy of Pediatrics and consisted of brief counseling by the pediatric provider followed by 1 visit and 4 telephone calls by older peer counselors aged 21 to 25 years. A consecutive sample of patients aged 13 to 17 years scheduled for an office visit was eligible regardless of smoking status. Of 2711 patients who agreed to participate, 2709 completed baseline assessments, and 2700 (99.6%) and 2690 (99.2%) completed 6- and 12-month assessments, respectively. RESULTS: Compared with the usual care condition, nonsmokers who received the provider- and peer-delivered intervention were significantly more likely to self-report having remained abstinent at 6-month and 12-month follow-up; smokers who received the provider- and peer-delivered intervention were more likely to report having quit at the 6-month but not the 12-month follow-up. A number of adolescent characteristics (eg, age, peer smoking, tobacco dependence, and susceptibility) were found to be predictive of abstinence at follow-up. CONCLUSIONS: A pediatric practice-based intervention delivered by pediatric providers and older peer counselors proved feasible and effective in discouraging the initiation of smoking among nonsmoking adolescents for 1 year and in increasing abstinence rates among smokers for 6 months.

Smoking prevention and cessation intervention delivery by pediatric providers, as assessed with patient exit interviews.

OBJECTIVE: The goal was to evaluate the degree to which a smoking prevention and cessation intervention was delivered by providers to adolescents in the pediatric office setting. METHODS: Eight pediatric clinics in central Massachusetts were assigned randomly to either a special intervention (brief pediatric provider-delivered intervention plus peer counseling) or the usual care condition. Subjects (n = 2710) were adolescents 13 to 17 years of age, both smokers (smoked in the past 30 days) and nonsmokers/former smokers. The degree to which smoking prevention and treatment interventions were delivered by providers was assessed through patient exit interviews with adolescents after their clinic visits; interviews assessed the occurrence of 10 possible intervention steps. RESULTS: The percentage of providers engaging in the smoking interventions differed significantly between the special intervention and usual care conditions, according to adolescent reports in the patient exit interviews. For nonsmokers/former smokers, overall patient exit interview scores were 7.24 for the special intervention condition and 4.95 for the usual care condition. For current smokers, overall patient exit interview scores were 8.40 and 6.24 for the special intervention and usual care conditions, respectively. Intervention fidelity of special intervention providers was 72.2% and 84.0% for nonsmokers/former smokers and current smokers, respectively. CONCLUSIONS: Pediatric providers who receive training and reminders to deliver a brief smoking prevention and cessation intervention to adolescents in the context of routine pediatric primary care practice can do so feasibly and with a high degree of fidelity to the intervention protocol.

A comparison of the psychometric properties of the hooked on nicotine checklist and the modified Fagerström tolerance questionnaire.

We compared the psychometric properties of the Hooked on Nicotine Checklist (HONC) and the Modified Fagerström Tolerance Questionnaire (MFTQ). Adolescent current smokers (n = 215) completed both instruments three times, at baseline and 6- and 12-month follow-up. Internal consistency of the HONC was high (alpha = 0.92), as was its stability over the follow-up interval (intraclass correlation (ICC) = 0.93 over 6 months and 0.91 over 1 year). Internal consistency of the MFTQ was acceptable (alpha = 0.83), and its stability over the follow-up interval was similar to that reported previously (ICC = 0.79 at 6 months and 0.76 at 1 year). The HONC predicted smoking at both follow-up points, while the MFTQ did so only at 6 months. The HONC compared favorably with the MFTQ in all respects. The most important advantage of the HONC is that it is measuring a clearly defined concept, diminished autonomy over tobacco, which begins when the sequelae of tobacco use present a barrier to quitting.