Abstract: Quitting smoking will add an average of seven years to a parent's life, improve the health of the spouse, eliminate the majority of secondhand smoke exposure of the children, reduce tobacco-related poor pregnancy outcomes, eliminate the greatest cause of house fire mortality, and improve the financial resources of the family. Much research has been done developing techniques to enhance the provision of evidence-based tobacco control in the adult primary care practice setting but parents may not have a primary care clinician and even when they do, often visit their child's doctor more frequently than their own. We developed an intervention to address parental smoking in the child healthcare setting to employ, in combination, evidence-based smoking cessation techniques including the 5 A's (Ask, Advise, Assess, Assist, Arrange), proactive referral to regional and national "quitlines", and pharmacologic management of tobacco dependence. We will compare our intervention to an "attention" control consisting of handing out a usual care tobacco control pamphlet. This will be a randomized controlled trial (RCT) of effectiveness that builds on pilot work supported by the National Cancer Institute, the Flight Attendants Medical Research Institute, and the Robert Wood Johnson Foundation. It will be conducted in the American Academy of Pediatrics Pediatric Research in Office Settings (PROS) practice-based research network, the largest research network of pediatric practices in the United States. Findings will be widely reproducible and transportable through the more than 700 PROS practices (which provide care to 3 million, or 5% of the nation's children) and to other practice networks and practices nationally. We will be testing a previously developed, pilot tested, and theoretically-based intervention designed to improve adherence to evidence-based guidelines at the clinician level, facilitate change at the parent behavior level, and lead to implementation of systems changes at the practice level. Specifically, the research plan addresses Aims at the clinician level, parent behavior level, and practice level, that relate to empiric Hypotheses at each of these levels.

Abstract: Most adolescent smokers want to quit and have tried to unsuccessfully. While adult cessation counseling is effective, the evidence for cessation counseling for adolescents is limited. We propose a pilot study essential to developing future randomized clinical trials of the effectiveness of adolescent cessation interventions in pediatric primary care settings. In a previous AHRQ funded study, we piloted clinician training and practice systems change interventions. In this proposed R-21 project, we build on these successful strategies and pilot delivery of interventions to adolescents, evaluation of adolescent receipt of counseling, and cessation outcomes. We will test these strategies in partnership with the American Academy of Pediatrics Pediatric Research in Office Settings (PROS) practice based research network (PBRN). Our specific aims are to: 1) Establish the feasibility of practices' recruitment of adolescents and families for research evaluation; 2) Further demonstrate fidelity to implementation and maintenance of guidelines based system changes and clinician cessation counseling interventions over time, including: a) systematic screening using charting tools; b) behavior change counseling using the public health service 5 A's model, and c) clinician referral of adolescent patient to Internet and community-based adjuncts and resources, and 3) Assess the impact of these pilot interventions on delivery of cessation interventions, and on intermediate outcomes, including self-reported quit attempts and cessation outcomes. We will evaluate practice recruitment and smoking cessation training and delivery by providers in 10 PROS practice sites, and assess acceptability of study procedures to adolescents in these sites. Our systems intervention draws from literature on practice systems changes using Wagner's chronic disease Care Model, and our clinical interventions on the transtheoretical (stages of change) model and the Public Health Service 5A model for effective behavior change counseling. Up to 1000 adolescents will complete a short baseline survey prior to well-visits. Smokers will be surveyed by phone at 2-3 weeks and at 3 and 6 months, to provide preliminary estimates of cessation outcomes for future studies. We will test measures, describe patterns of smoking among youth, and explore the effect of interventions on motivation, quitting, abstinence/ relapse attitudes and other smoking behaviors for 100 smokers. This project will result in pilot data on implementation essential to conducting future large PBRN-based trials of adolescent cessation in pediatric care. Studying clinician interventions in primary care community-based pediatric practice has the potential to lead to improved clinical preventive services for tobacco cessation and also to rapid dissemination of effective interventions.

Abstract: Overview. Jonathan P. Winickoff MD, MPH, an academic pediatrician, is applying for a Cancer Prevention, Control, Behavioral and Population Sciences Career Development Award (K07) to develop and enhance the skills necessary to become a successful independent investigator in the field of cancer prevention and control. His long-term goal is to develop a multidisciplinary research program dedicated to improving the health of parents who smoke and the children exposed to their environmental tobacco smoke. Career Development Plan. Central to Dr. Winickoff's career development are the strong institutional commitments and mentoring team that he has assembled. His multidisciplinary education plan is built upon acquiring new skills in organizational effectiveness theory, advanced biostatistics, bioethics, models of tobacco control and preventive services delivery, and policy research. In addition to formal coursework, the plan includes local seminars, national scientific meetings, and peer-reviewed publication of results. Research Plan. The goal of this research plan is to develop and test an office system to enhance the delivery of evidence-based tobacco treatment services to parents of children seen in pediatric practice. In three phases, the research plan uses exploratory, descriptive, and intervention designs to address parental tobacco control in the pediatric outpatient setting. Each phase of the research builds on what has been learned in the prior phase. Phase 1 is an exploratory study consisting of the preliminary adaptation of an evidence-based tobacco control strategy to the pediatric outpatient setting. Phase 1 is grounded on the Solberg and Wagner theoretical models, multiple interviews with each of several leaders in the field of outpatient preventive services implementation, and iterative adaptation of the proposed tobacco control office system based on these key interviews. Phase 2 is a qualitative study using focus groups from 8 pediatric practices to elicit pediatrician and key staff responses, barriers, and solutions to implementing the proposed tobacco control office system. Phase 3, an intervention study, examines the feasibility and efficacy of implementing within the pediatric office setting the tobacco control system that was developed in Phase 1 and refined in Phase 2. The design is a before-after design with one practice serving as the control. The primary outcome is the enrollment of identified parental smokers into centralized tobacco control infrastructure increasingly available throughout the United States. Results should justify a larger trial with randomization at the practice level. In summary, the research plan will provide critical information about evidenced-based tobacco control within pediatric practice, and crucial experience for Dr. Winickoff in qualitative data analysis, survey methods, primary data collection, database management, statistical analysis, and intervention research.