System level strategies for implementing tobacco use treatment guidelines exist but are insufficiently put into practice, particularly in dental care settings. Closing the gap between research and practice is stymied by the limited research on systems changes necessary to implement tobacco treatment in routine dental care. Drawing from a burgeoning dissemination science literature, the proposed study compares the cumulative benefit of the following three systems-level strategies: 1) staff training and clinical reminders, 2) provider feedback and 3) pay-for- performance (financial incentives), that have been widely endorsed by a 2001 Institute of Medicine Report, "Crossing the Quality Chasm" (IOM 2011) and the 2008 PHS Guidelines (Fiore 2007, Fiore 2008, IOM 2011).

The investigators propose a 3-arm cluster randomized controlled trial that will analyze the implementation process and compare the cost and effectiveness of three implementation strategies: 1) Staff training and CBP in implementing PHS Guidelines; 2) CBP + provider performance feedback (PF) and 3) CBP + PF + Pay-for-performance (provider reimbursement for tobacco cessation treatment delivery). Guided by Organizational Change Theory and the Theory of Planned Behavior (Ajzen 1991, Damschroder 2009, Greenhalgh 2004, Solberg 2007) the investigators will identify multi-level factors that facilitate or impede the implementation process in dental clinics. Our primary outcome is improvement in provider delivery of tobacco cessation treatment found through extensive meta-analysis (Fiore 2008) to be an essential determinant of patient cessation outcomes. Our secondary outcome will be post-intervention patient-reported quit rates. In addition to examining the comparative effectiveness of the three implementation strategies, the investigators will use a mixed methods approach to examine implementation processes (Aim 2) to assess the degree to which the interventions are integrated into practice as intended and to clarify the mechanisms through which the intervention influences provider behavior.

Purpose of the Study System level strategies for implementing tobacco use treatment guidelines exist but are insufficiently put into practice, particularly in dental care settings. Closing the gap between research and practice is stymied by the limited research on systems changes necessary to implement tobacco treatment in routine dental care. Drawing from a burgeoning dissemination science literature, the proposed study compares the cumulative benefit of the following three systems-level strategies: 1) staff training and clinical reminders, 2) provider feedback and 3) pay-for- performance (financial incentives), that have been widely endorsed by a 2001 Institute of Medicine Report, "Crossing the Quality Chasm" (IOM 2011) and the 2008 PHS Guidelines (Fiore 2007, Fiore 2008, IOM 2011).

Staff Training and Clinical Reminder Systems. The PHS Guideline strongly recommends staff training, clinical reminder systems and other practice supports as the foundation for treating tobacco dependence in health care settings. Despite observed limitations (Curry 2008, Grimshaw 2003, Shelley 2010), staff training, practice supports, clinical reminder systems and referral pathways represent current best practices (CBP) for screening and treating tobacco dependence.

Performance Feedback (PF). In recent randomized trials conducted in primary medical care settings, clinical audit and feedback with regard to tobacco treatment performance have been associated with a twofold increase in cessation assistance and referral to cessation quitlines (Bentz 2007, Curry 2008, Wadland 2007). While clinical audit and feedback have been shown to increase provider adherence to tobacco use treatment guidelines in medical settings, these strategies have not yet been examined in dental practice (Curry 2000, Curry 2008, Fiore 2007, Fiore 2008, Grimshaw 2006, Solberg 2000).

Pay for Performance (P4P). P4P or providing financial incentives for meeting predetermined performance goals has attracted much interest as a strategy to improving guideline implementation and the quality of care (Petersen 2006, Sonnad, 1998). The recent consensus report from the 2nd European Workshop on Tobacco use Prevention and Cessation for Oral Health Professionals emphasized the importance of appropriate compensation of tobacco use treatment to provide incentive to oral health providers (Ramseier 2010). Several studies have demonstrated a positive association between P4P and adherence to recommended tobacco use treatment (An 2008, Coleman, 2010, Roski, 2003). For instance, An et al, found that a P4P program increased referrals to statewide tobacco quitline services (An 2008). Electronic dental records and automated billing systems (such as the Dentrix system used by most of our participating dental clinic sites) are adding nicotine dependence diagnostic and treatment procedure codes. This health informatics trend bodes well for the sustainability of performance feedback and P4P implementation strategies.

Background Based on meta-analyses of over 8000 tobacco cessation studies published in the past three decades, the 2008 Public Health Service (PHS) Guideline, Treating Tobacco Use and Dependence provides strong evidence that provider delivery of tobacco dependence treatment, including cessation pharmacotherapy and brief counseling, can produce significant and sustained reductions in tobacco use and should be delivered to all smokers seeking routine health care (Fiore 2008). Provider adherence to the PHS Guideline recommendations requires Asking all patients about tobacco use, Advising smokers to quit, Assessing readiness to quit, providing cessation Assistance and Arranging follow-up (5As) (Fiore 2008). Adequate implementation of the PHS Guidelines would generate 1.6 million additional quitters per year and nearly 3.3 million quality life years saved (USDHHS 2000).

Despite the existence of effective tobacco dependence treatments, inadequate adoption, particularly among low income and ethnic/racial minority smokers, has contributed to growing disparities in smoking prevalence and tobacco-related illness (Fagan, 2007, King 2010, Lopez-Quintero 2006). For instance, Hispanics are 57% and African-Americans 13% less likely to receive physician advice to quit than non-Hispanic whites (Lopez-Quintero 2006). Citing persistent missed opportunities to promote tobacco cessation, the Institute of Medicine's (IOM) report, "Ending the Tobacco Problem: A Blueprint for the Nation", calls for greater efforts to implement effective tobacco cessation interventions in health care settings. The USDHHS Task Force on Tobacco Control recently highlighted the need to better understand provider incentives and other system-level strategies to motivate provider adherence to PHS guidelines and leverage emerging opportunities for reimbursement of preventive services as presented by the 2010 Affordable Care Act. These recent health policy reports highlight the need and potential public health value of reducing tobacco-related disparities through dissemination of evidence-based interventions in health care delivery systems serving low income and other high-risk smokers (Medicine. lo 2007, Services US Department of Health and Human Services 2010).

Dental care settings have several advantageous features for delivery of tobacco cessation treatment including: 1) broad reach with 62.8% of 18-64 years olds reporting at least one annual dental visit (Manski 2007), 2) access to patients who do not receive other healthcare services (10% of dental patients do not regularly see a physician) (Strauss 2006), 3) the dental team routinely provides preventive services; and 4) controlled trials have demonstrated the efficacy of dental office-based cessation interventions (Gordon 2006). Moreover, dental professionals have a credible role in providing tobacco cessation treatment in view of the oral hazards of tobacco use. A recent national survey found that 88.7% of dentists and 96% of dental hygienists reported that treating tobacco use was an important professional responsibility (Tong 2010). Although most dentists still work in private practice settings, there are about 475 federally-funded, community or neighborhood health centers with dental clinics and another 250 community dental clinics throughout the United States (Gordon 2005). These community dental health centers serve predominantly low income populations known to have a high prevalence of smoking (Gordon 2010). Therefore, the potential impact of implementing the Tobacco Guidelines in these public health dental clinics is substantial (Gordon 2006). Unfortunately, delivery of tobacco use treatment in routine dental care remains limited (Albert 2002, Albert 2005, Tong 2010).

Although national surveys indicate that dental providers are increasingly screening for tobacco use and offering brief advice, adherence to the PHS guidelines in inconsistent with only 10-25% dental health professionals' routinely delivering cessation assistance (e.g. cessation pharmacotherapy prescriptions and/or referral for cessation counseling) (Albert 2002, Tong 2010). Dentists most often cite lack of training, and adequate reimbursement to explain their subpar performance in providing tobacco cessation interventions (Albert 2005). Challenges to wide-scale implementation of tobacco dependence treatment also include a lack of referral resources and a lack of office-based systems (Gordon 2006, Albert 2005). PHS guideline implementation is likely affected by both provider attitudes and organizational priorities that impact provider behavior (Albert 2002, Curry 2000, Fiore 2008).

Study Design We propose a 3-arm cluster randomized controlled trial that will analyze the implementation process and compare the cost and effectiveness of three implementation strategies: 1) Staff training and CBP in implementing PHS Guidelines; 2) CBP + provider performance feedback (PF) and 3) CBP + PF + Pay-for-performance (provider reimbursement for tobacco cessation treatment delivery). Guided by Organizational Change Theory and the Theory of Planned Behavior (Ajzen 1991, Damschroder 2009, Greenhalgh 2004, Solberg 2007) we will identify multi-level factors that facilitate or impede the implementation process in dental clinics. Our primary outcome is improvement in provider delivery of tobacco cessation treatment found through extensive meta-analysis (Fiore 2008) to be an essential determinant of patient cessation outcomes. Our secondary outcome will be post-intervention patient-reported quit rates. In addition to examining the comparative effectiveness of the three implementation strategies, we will use a mixed methods approach to examine implementation processes (Aim 2) to assess the degree to which the interventions are integrated into practice as intended and to clarify the mechanisms through which the intervention influences provider behavior.

Clinic level selection of performance sites is guided by our desire to ensure that our findings would be generalizable to real-world dental health care settings serving diverse population of smokers. We will partner with 18 public health dental clinics that have expressed willingness to participate. For practical (cost and staffing) reasons, we will recruit clinics in six successive waves with three sites enrolled per wave (see Timeline). Clinic randomization will be conducted by the Memorial Sloan Kettering Cancer Center Clinical Research Database Program (CRDB) within the Biostatistics Service using the random permuted block method.

Inclusion Criteria:

• Clinics are included if they are located within the NYC metropolitan area and employ at least three FTE dentists.
• Providers are included if they practice full-time or part-time at one of the study clinics
• Patients are included if they are 18 years or older, active smokers defined as those who report smoking cigarettes some days, most days, or every day and have smoked in the past 7 days, have an appointment with a dentist or hygienist, NYS resident, speak English, Spanish, Chinese or Russian, and are able to comply with study procedures in the opinion of the principal investigator.

Exclusion Criteria:

• Clinic locations are excluded if the number of unique adult patient visits per week averages less than 100, if the dental director reports that the clinic assists more than 60% of patients with tobacco cessation and if the clinics policies would prohibit the clinic from accepting pay-for-performance funds if randomized to that arm. All sites with less than 3 dental providers will also be excluded.
• Providers are excluded if they do not speak English.
• Patients are excluded if they do not speak English, Spanish, Chinese or Russian, and if they have already completed the patient exit interview during the same intervention phase.