CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 3,207 enrolled
Drug / intervention
Audit and performance feedback (PF) +2 morebehavioral
Likely dose
Not stated in record
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Search/NCT01615237
NCT01615237N/ACompleted

Implementing Tobacco Use Treatment Guidelines in Dental Public Health Clinics

NYU Langone Health·interventional·Posted Jun 8, 2012·Updated Feb 15, 2019

In Brief

A clinical study evaluating Audit and performance feedback (PF), Financial Incentive (P4P), and 1 other intervention for Tobacco Use Treatment. Completed, enrolled 3,207 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 8, 2012
Enrollment StartMar 9, 2013
Primary CompletionDec 8, 2018
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 14.1 years ago

Interventions

Audit and performance feedback (PF)behavioral

Quarterly, trained clinic staff will use a standardized chart audit tool to evaluate documentation of cessation assistance. The feedback report will show individual and clinic performance summaries of two targeted provider behaviors based on documentation in the chart: 1) percentage of smokers advised to quit, and 2) percentage of smokers who received quitting assistance. Quitting assistance will be fulfilled by documentation of any of the following provider behaviors: a) Faxing a referral to the New York State (NYS) Quitline, b) Chart documentation of providing cessation counseling; and/or c) discussing and or prescribing cessation medications. Reports will be given to the Dental Director, who will be instructed to distribute them to dental providers no later than 30 days following the end of the quarter.

Financial Incentive (P4P)behavioral

We will review charts of all smokers to evaluate documentation of cessation assistance (i.e., prescription given for cessation medication, the provision of brief cessation counseling and/or a fax referral to the NYS Quitline or other local cessation support program). Sites will receive $20 for each patient with chart documentation of receiving tobacco cessation assistance. The P4P reimbursement will be offered quarterly with an annual cap of $5000 to each site as employees are salaried.

Current Best Practices (CBP)behavioral

CBPs that will be implemented is consistent with the PHS recommended guidelines and is as follows: The dental care team will assess smoking status, deliver advice to quit, assess readiness to quit, provide patient education materials, a prescription for cessation pharmacotherapy and referral to the NYS Quitline, and document findings and treatment plan on the chart system. In New York State, the Quitline provides free medication for uninsured. As brief provider interventions have been shown to be effective, the recommended tobacco treatment protocol will require approximately 5-10 minutes.