Please select the eligibility criteria that correspond to the clinical trial below.
Title: Implementing Tobacco Use Treatment Guidelines in Dental Public Health Clinics
Brief Summary: 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.


Options:
A: Inclusion Criteria por prenatal clinics:

* Not having a smoking cessation program based on the "5 A's" for pregnant women in place.
* An estimated frequency of women receiving the "5 A's" intervention below 20%
* Having midwives or nurse-midwives as part of the hospital or primary health center staff.
* Having signed a letter of intention to participate in the project.
* Having at least 400 new pregnant women per year.

Exclusion Criteria for prenatal clinics:

* None
B: DISEASE CHARACTERISTICS:

* Parents or guardians meeting the following criteria:

  * Self-identified as smokers on the baseline survey
  * Must have a child who is seen by a pediatrician in a participating practice

    * Child must not have a medically emergent condition that requires transfer outside the practice for immediate medical intervention
  * Must be present at the child's healthcare visit
* Pediatric practice meeting the following criteria:

  * Participates in the Pediatric Research in Office Settings (PROS) network
  * Practice manager and a majority of pediatricians are willing to implement a tobacco control strategy for parental smokers
  * Cares for at least 2,000 families
  * Located in a geographically distinct location to minimize contamination effects of the intervention

    * No practices at the same geographic location

PATIENT CHARACTERISTICS:

* Have a telephone at home (parent or guardian)
* Able to speak English (parent or guardian)
* Have a working fax machine (practice)

PRIOR CONCURRENT THERAPY:

* No prior enrollment in this study during a previous visit to the pediatric healthcare clinician (parent or guardian)
* No prior participation in phase II focus groups or other pilot tobacco control studies (practice)
* No active enrollment of patients onto other PROS trials (practice)
C: Inclusion Criteria:

* Smokers
* Accept participation and follow-up by phone interviews for 2 years

Exclusion Criteria:

* Terminal illness
* Active addictive behaviours or important health problems
D: 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.

Answer: D