DESCRIPTION (provided by applicant): The goal of this renewal application is to transform routine pediatric outpatient practice to assist parents quitting smoking in order to help eliminate
tobacco use in families. In our Phase I RCT (R01-CA127127), framing the intervention from the practice perspective using the Chronic Care Model (Wagner) and the Prevention System (Solberg), we demonstrated dramatic office systems changes without additional resource added to practices, showing 14-fold increased rates of delivering tobacco control assistance in a practice-based research network, and justifying significant investment to disseminate nationally. The intervention included three key implementation steps to address parental smoking in the child healthcare setting: (1) motivational messaging; (2) proactive referral to quitlines; and (3) pharmacologic management of tobacco dependence. The intervention was recently named an "innovation in medicine" by AHRQ. In the proposed Phase II trial, in close collaboration with the American Academy of Pediatrics (AAP), the largest pediatrics professional organization in the United States, we will perform a two-arm RCT to address the critical unanswered questions of generalizability, sustainability, and cost- effectiveness of the intervention using a national 20-ste sample of pediatric practices. The Phase II intervention will be augmented to address key barriers identified in Phase 1 and to enhance generalizability and sustainability by: (1) including
facilitated nicotine replacement delivery-compliant with new national Medicaid coverage standards and (2) including an innovative additional dissemination and sustainability component, developed with a separate NCI ARRA grant--an online, tailored, self-paced module where clinicians work on a full practice implementation over the course of several months of self study and hands-on improvement cycles. The module satisfies the new American Board of Pediatrics Maintenance of Certification Performance in Practice requirement creating a natural "pull" for the training. The Specific Aims include: " Aim 1. to implement and sustain adherence to evidence-based guidelines at the clinical level; " Aim 2. to facilitate behavior change among parents and evaluate cost per quit among parents who smoke; " Aim 3. to study systems changes and the processes that affect them at the practice level. Building on the success of Phase 1, the generalizable training systems to be studied in this application will enhance the adoption, implementation, and sustainability of the intervention, making it widely transportable throughout pediatric practice nationally and providing a critical return on decades of NIH investment in developing the evidence base for tobacco control. The project will have significant impact by yielding an effective, theoretically-based, rapidly disseminable, and sustainable strategy to address tobacco use in families through child healthcare settings in the United States.
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