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Implementing Tobacco Use Treatment Guidelines in Dental Public Health Clinics

Phase 0
21 Years
Open (Enrolling by invite only)
Tobacco Cessation

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Trial Information

Implementing Tobacco Use Treatment Guidelines in Dental Public Health Clinics

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.

Inclusion Criteria:

- Selection of performance sites is guided by our desire to insure 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 sites in six successive waves with three sites enrolled per
wave (see Timeline). Site 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.

Exclusion Criteria:

- Pediatric dental clinics and no dental clinic at the community health center site are
two items of exclusion from the study. In addition, at least 2 dental providers must
be present at each site. All sites with less than 2 dental providers will also be

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Outcome Measure:

To assess the primary outcome of provider adherence to tobacco use treatment guidelines, we will conduct patient exit interviews with 100 smokers pre and post-intervention at each of the 18 study sites (1800 smokers pre and post).

Outcome Description:

The Patient Exit Interview (PEI) is a brief patient-reported measurement tool for the assessment of provider delivery of tobacco use treatment. Patients will be approached during their clinic visits by trained research study assistants, to determine smoking status and to obtain consent. Patient eligibility includes: 1) age 18 or over; and 2) active smokers defined as those who report smoking within the past 7 days.

Outcome Time Frame:

prior to and approximately 12 months following each site's enrollment in the study

Safety Issue:


Principal Investigator

Donna Shelley, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

New York University School of Medicine


United States: Institutional Review Board

Study ID:

1 R01 CA162035-01A1



Start Date:

February 2013

Completion Date:

September 2017

Related Keywords:

  • Tobacco Cessation



Memorial Sloan Kettering Cancer CenterNew York, New York  10021
New York University School of MedicineNew York, New York  10016