Dentists United to Extinguish Tobacco (DUET): a study protocol for a cluster randomized, controlled trial for enhancing implementation of clinical practice guidelines for treating tobacco dependence in dental care settings

All clinical (i.e., dentists, dental hygienists, and/or dental assistants) and support staff will be trained in the use of the intervention protocol during a one-hour, slide presentation. The didactic training is based on the PHS guideline [1] and will include content on prescribing smoking cessation pharmacotherapy, how to use the Refer-to-Quit system and other local cessation referral resources, and a review of NYS health insurance coverage for cessation treatment. The protocol includes the provision of pharmacotherapy consistent with American Dental Association (ADA) recommendations [51]. The initial training presentation will be standardized and conducted by the study co-leaders (DS/JO) and offered onsite at each individual field site. To reinforce the new clinical protocol for documenting and treating tobacco use, each site will receive a 30-minute booster training session approximately three months after the initial training presentation.

Quitlines substantially increase abstinence rates compared to minimal or no counseling [1]. Started in 2000, the NYS Quitline counseled 82,776 current and former smokers in 2012 [52]. The Refer-to-Quit program simplifies the healthcare provider referral process by offering clinical practices a strategy to easily link patients to the NYS Quitline using either a secure online website or a pre-printed fax referral form. The Quitline makes five attempts to reach patients within one week after receiving the fax or online referral. If the Quitline is unable to reach a patient, a letter is sent encouraging the individual to contact the Quitline for assistance. Smoking cessation counselors at the NYS Quitline provide one proactive telephone counseling session and distribute a two-week supply of free nicotine replacement therapy (NRT). A list of local community referrals for high-risk smokers needing more intensive cessation and/or psychosocial services is also provided.

All dental providers will receive a Smoking and Oral Health Quit Kit developed specifically for dental care providers by the New York City Department of Health and Mental Hygiene (NYC-DOHMH) [53]. The toolkit contains a call to action letter from the Commissioner of the NYC-DOHMH confirming that treating tobacco use, including prescribing cessation medications, is within dentists’ scope of practice, a provider resource guide for delivery of cessation counseling, patient education booklets describing the oral health effects of tobacco and the benefits of quitting, a pharmacotherapy prescribing information card tailored for dental providers, a summary of oral health in New York City, and a waiting room poster. In addition, our project added Fax/Refer-to-Quit forms to facilitate referral to the NYS Quitline, and a brief version of the PHS Guideline for Treating Tobacco Dependence [1].

Clinic sites randomly assigned to arm two will also receive quarterly performance reports on provider delivery of cessation services using chart audit procedures. The research team will work with each of the study sites to develop a system that will allow smokers to be readily identified and placed in a smokers’ registry. This system will vary depending on whether or not the site uses an electronic or paper chart. Quarterly queries of the registry by trained clinic staff will be conducted using a standardized chart audit tool to evaluate documentation of cessation assistance. Each site will be provided and trained on an audit and feedback protocol and the process for disseminating feedback to individual providers. The PF report (see Appendix) will show individual and aggregated clinic performance summaries of targeted 5As provider behaviors benchmarked against other similar clinics and a recommended standard of practice (80%). Quitting assistance will be demonstrated by chart documentation of any of the following provider behaviors: making a referral to the NYS Quitline, or other community-based cessation program; providing cessation counseling; and/or discussing and or prescribing cessation medications [54]. Quarterly reports will be given to the dental director, who will be instructed to circulate and discuss them with the field site’s dental providers within 30 days.

Clinic sites randomly assigned to arm three will receive CBP, quarterly PF reports, and financial incentives for documenting delivery of adherence to clinical practice guidelines. Using the same chart auditing procedures described above, charts of all smokers will be reviewed for documentation of cessation assistance (i.e., prescription given for cessation medication, the provision of brief cessation counseling and/or a referral to the NYS Quitline or other local cessation support programs). Sites will receive $20 for each patient with chart documentation of receiving tobacco cessation assistance. The P4P reimbursement bonus will be offered quarterly with an annual cap of $5,000 per dental clinic. The P4P procedures are guided by published work done by Roski (2003). The incentive amount is also consistent with the current Medicare and New York State Medicaid reimbursement [55, 56] schedule for 10 minutes of smoking cessation counseling and represents an amount deemed appropriate by members of our advisory committee representing the ADA and the dental insurance industry.

The selection of clinic sites is guided by our intent to insure that findings will be generalizable to real-world dental healthcare settings serving diverse population of smokers. The trial will be conducted in partnership with 18 public health dental clinics employing at least two full-time dentists, not fully adherent to PHS guidelines, able to accept additional compensation if assigned to the P4P arm and serving low-income patients in the New York metropolitan region. For practical (cost and staffing) reasons, clinic sites will be recruited in six successive waves with three sites enrolled per wave. Site randomization will be conducted using the random permuted block method with stratification by clinic volume (small, medium, large). Prior to enrollment, clinics will be categorized as small (100 to 400 patients per week), medium (401 to 750 patients per week) or large (>750 patients per week) based on the number of adult patients seen per week per the dental director. Clinics whose patient volume is less than 100 patients per week will be excluded. Matching the clusters has several practical and statistical advantages. Of particular importance is that matching offers some control for background effects (e.g., cigarette pricing and other public policy changes) contemporaneous of the current trial [57]. Baseline data collection will be completed prior to randomization. If the baseline providers’ assessment reveals that the site assists more than 60% of patients who smoke, then the clinic will be excluded and replaced with an alternate site of similar patient volume.

To assess the primary outcome of provider adherence to tobacco use treatment guidelines, we will conduct and compare pre- and post-intervention patient exit interviews conducted with eligible smokers at each of the 18 clinic sites. Prior to beginning of the implementation intervention, we will conduct 100 patient exit interviews (n = 1,800 pre-intervention) at each clinic site. Then, after each site has completed the planned intervention, another independent sample of 100 smokers will complete patient exit interviews (n = 1,800 post-intervention). Patient interviews conducted at the point of service are considered to be the optimal non-observational method for measuring provider delivery of outpatient treatment [58, 59]. A modified patient exit interview (PEI) [60] will be used as a brief patient-reported measurement tool for the assessment of provider delivery of tobacco use screening and treatment. A PEI index (summary) score is determined by adding the number of tobacco treatment behaviors each patient reports that the provider implemented during the most recent visit. PEI index will scores range from 0 to 8. The questions assess the full spectrum of PHS guideline recommended care (i.e., 5As). For example, patients are asked if their provider advised them to quit, offered cessation counseling and/or discussed cessation medications. The PEI has well-established validity as evidenced by strong correlation with more costly audio-taped assessment of physician-patient interactions (r = 0.67, p < 0.001) and has been commonly used to accurately measure providers’ delivery of tobacco cessation assistance efforts during office practice, and to monitor providers’ adherence to tobacco cessation treatment guidelines in clinical trials. Prior to and approximately nine months following each site’s enrollment, consecutive patients will be approached during their clinic visits by trained research study assistants (RSA), to determine current smoking status and to obtain consent for the PEI. Patient eligibility will include those: age 18 or over; English- or Spanish-speaking; current smokers defined as those who report smoking within the past seven days; New York State residents; and who have an appointment with a dentist or hygienist for routine non-emergent care. Immediately after their dental visit, patients will complete the PEI to assess provider adherence to the PHS Guideline (5As). We expect that most surveys will be administered using a computer tablet with a password protected, web-based data entry portal (REDCap) [61]; however, paper surveys will be available, as needed.

Following recommendations for cost assessment methodology described by Ritzwoller et al., [62] research costs (e.g., labor and other inputs associated with grant administration, IRB approval, manuscript preparation), and direct clinical intervention costs (e.g., dental provider time associated with counseling patients, staff training, IT costs, reimbursement costs) will be estimated. Templates have been developed to capture data prospectively to improve accuracy and precision of cost assessment. The NYS Quitline has estimates of their counseling cost per quit. The costs of the medications taken by the patients as part of their cessation attempt (reported at the three-month telephone survey) will be estimated. In addition, as part of the follow-up assessment, patients will complete the EQ5D, which is a commonly used patient self-report measure of health status. Applicable to a wide range of health conditions, this measure provides a single index value for health status that can be used in the clinical and economic evaluation of healthcare^.[63].

To assess patient utilization of cessation services and smoking abstinence, follow-up telephone interviews, three months post-clinic visit, will be conducted with smokers who complete the post intervention PEIs. A standardized interview will be used to collect patient-reported cessation outcomes including seven-day abstinence and 24-hour quit attempt and use of cessation treatment during the past three months.

Measures for four TPB variables (attitudes, subjective norms, perceived behavioral control, and intentions) are based on modifications of selected subscales from established survey tools developed by Park [66], Amemori [64], Francis [50] and Grimshaw et al.[48] to assess knowledge and attitudes regarding treatment of tobacco dependence, clinic norms, and perceived behavioral control, and intentions. We will use a modified version of the Perceived Organizational Priority Survey [65] to assess the perceived priority of tobacco use treatment at the dental clinic. We also adapted a tool by Weiner et al. to measure additional organizational factors that may influence provider behavior [42]. Semi-structured interviews will be done after completion of the intervention period with the dental director at each of the participating dental clinics. The interviews will focus on site-specific barriers and facilitators of strategy implementation, the process of integrating and customizing the implementation strategy into the clinic site workflow as well as acceptability and satisfaction.

The Change Process Capability Questionnaire (CPCQ) will be used to assess baseline measures of organizational capacity to change [71]. The survey measures several domains of change capacity: history of change, plans for continuous organizational refinement, ability to initiate and sustain change, and strategies for process improvement.

At baseline, data on organizational variables shown to influence implementation of provider practice guidelines including number of full-time equivalent staff, insurance payer mix, hospital-based or freestanding clinic, academic affiliation, clinic volume, and staff characteristics will be collected [67‐70, 72]. Dental directors will complete surveys in order to identify pre-intervention clinical systems and policies (e.g., electronic or paper chart system).

We will use several approaches to measure fidelity of the three implementation strategies [73].

The dental directors will be queried at three, six, and nine months to confirm date of distribution of the quarterly PF reports.

The dental directors assigned to P4P will be also asked at 3, 6, and 9 months to confirm receipt of the quarterly financial incentive earmarked to performance of tobacco treatment interventions.

Eighteen dental clinic sites will be recruited and randomly assigned to one of three implementation strategies in a cluster-randomized design. The general statistical paradigm for assessing outcomes will be based on a Multi-Level Model (MLM) approach [74] (also known as ‘hierarchical linear model’) [8, 32, 75, 76]. MLM adjusts for the clustering effects across multiple levels (patients, providers, dental clinics) of hierarchical data structure. Before the implementation strategies are rolled out, 100 patients per site will be assessed through standardized PEIs to establish the baseline level of dental provider assistance in tobacco cessation. Then each site will be randomly assigned and will receive their intervention condition for nine months. Following the intervention period, 100 new patients from each site will be recruited for assessment of post-intervention changes in provider adherence to the guidelines.

A two-level MLM will test of the effectiveness of the implementation strategies. The primary outcome is the summary score of the PEI assessment of provider assistance (score range 0 – 8). At level one, we will enter each patient’s PEI score of dental provider assistance as a function of intervention and time (pre and post intervention), thereby allowing each site to serve as its own pre-implementation control, an added benefit to minimize an order effect, (e.g., sites that enter the active implementation phase later may derive greater benefits due in part to improved efficiency in logistics coordination) [75‐77]. Additional covariates may also be included (e.g., patients’ age, gender, and education).

For the primary outcome of provider assistance behaviors, prior data from a recent clinical trial conducted to improve treatment of tobacco dependence in primary care was obtained [78, 79]. The investigators compared Intervention (a provider training and practice facilitation program similar to ours) with Usual Care. The Intervention group reported an average PEI provider assistance score of 8.40 (SD = 1.93) versus an average of 6.24 (SD = 2.12) in the Usual Care group, which translates to an estimated effect size of 1.02 (using the larger SD = 2.12). Using this 1.02 effect size, we estimated an 86% statistical power to detect such an effect at a two-sided Type-I error rate of 0.01 (to control for multiple comparisons) for 18 sites (six sites randomized to each intervention condition) and 100 post-intervention patients per site [80].

Statistical power was also estimated for provider assistance behaviors in a generalized estimating equation (GEE) approach. Bentz et al.[23] reported that 10.5% of providers randomized to the control condition gave active assistance (e.g., referrals to quitlines); and 20.1% of providers randomized to their feedback condition gave active assistance. Roski et al.[33] reported a 31.4% cessation assistance rate for sites randomized to a provider incentive condition. Hence, provider assistance rates are estimated to be 10%, 20%, and 30% (rounded to the nearest decimal point) for the CBP, CBP + PF, and CBP + PF + P4P arms, respectively. Horton’s simulation method [81] was applied to calculate the statistical power of a logistic GEE model. The simulated statistical power was 82% statistical power to detect a 20% versus 10% difference in a GEE model comparing CBP + PF versus CBP alone. The corresponding statistical power for the 30% versus 20% difference between CBP + PF + P4P and CBP + PF is 73%. The statistical power for the larger 30% versus 10% difference between CBP + PF + P4P and CBP alone is 97%. Other parameters in the simulations included a two-sided Type-I error rate of 0.01 to control for multiple comparisons and an intra-class correlation of 0.22, in prior work [23] that closely resembles our trial design.

Using the indicators described in the evaluation plan (See Table 3), relevant process data describing the implementation fidelity of the intervention strategies (CBP, PF, and PFP) will be summarized. All reporting of trial outcomes data will be consistent with cluster randomized CONSORT guidelines [82].