Loading search results
DUET
Implementing Tobacco Use Treatment Guidelines in Dental Public Health Clinics
Sponsor study identifier
interventional
3,207
1 country
2
Study Start
March 9, 2013
Actual (reported)Primary Completion
December 8, 2018
Actual (reported)Study Completion
December 8, 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 8, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 6, 2012
Actual (reported)June 8, 2012
Actual (reported)March 9, 2013
Actual (reported)December 8, 2018
Actual (reported)December 8, 2018
Actual (reported)To assess the primary outcome of provider adherence to tobacco use treatment guidelines, we will conduct patient exit interviews with 80 smokers pre and post-intervention at each of the 18 study sites (2880 smokers pre and post).
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.
prior to and approximately 12 months following each site's enrollment in the study
Compare the effectiveness of the three intervention arms on provider behavior for aiding patient's tobacco cessation
We will also conduct provider surveys with all participating dentists and dental directors, and focus groups with all participating dental providers, dental directors and other key informants, including stakeholders in administrative and technical roles before and after the intervention. For the provider surveys, we will be asking all the dental providers (dental directors, dentists, dental hygienists, dental residents) to complete the surveys. We expect to enroll approximately 30 providers at each site for a total of 540 providers for the provider surveys. The number of participating dentists from each site will vary depending upon the size of the dental practice.
June 2013-June 2017
Cost analysis
last two years of the study/ end of each site's enrollment period
assess patient utilization of cessation services and smoking abstinence
0-6 months post intervention phase
Field sites randomly assigned to Arm 2 will receive as an intervention current best practices and quarterly audits and performance feedback reports (PF) on provider delivery of cessation services using chart audit procedures that we have used successfully in prior work. Depending on what is used at the site, paper or Electronic Dental Record, we will work with the site to create a registry of patients who are tobacco users.
Field sites randomly assigned to this implementation condition (Arm 3) will receive current best practices (CBP), quarterly audit and performance feedback reports (PF), and financial incentives (pay for performance, P4P) for every documented (documentation in patient chart of counseling, prescription, or referral to the quit-line) delivery of adherence to clinical practice guidelines.
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.
New York University School of Medicine
New York, New York, 10016, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10021, United States
Albert DA, Severson H, Gordon J, Ward A, Andrews J, Sadowsky D. Tobacco attitudes, practices, and behaviors: a survey of dentists participating in managed care. Nicotine Tob Res. 2005 Apr;7 Suppl 1:S9-18. doi: 10.1080/14622200500078014.
Albert D, Ward A, Ahluwalia K, Sadowsky D. Addressing tobacco in managed care: a survey of dentists' knowledge, attitudes, and behaviors. Am J Public Health. 2002 Jun;92(6):997-1001. doi: 10.2105/ajph.92.6.997.
Donna Shelley, MD, MPH
NYU Langone Health
Jamie Ostroff, PhD
Memorial Sloan Kettering Cancer Center
3,207 participants (actual enrollment reported by the registry).
First Submitted
June 6, 2012
First Posted
June 8, 2012
Study Start
March 9, 2013
Actual (reported)All dental field sites will receive current best practices (CBP) for training and technical assistance in promoting adoption of clinical practice guidelines for treating tobacco dependence.
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
An LC, Bluhm JH, Foldes SS, Alesci NL, Klatt CM, Center BA, Nersesian WS, Larson ME, Ahluwalia JS, Manley MW. A randomized trial of a pay-for-performance program targeting clinician referral to a state tobacco quitline. Arch Intern Med. 2008 Oct 13;168(18):1993-9. doi: 10.1001/archinte.168.18.1993.
Bentz CJ, Bayley KB, Bonin KE, Fleming L, Hollis JF, Hunt JS, LeBlanc B, McAfee T, Payne N, Siemienczuk J. Provider feedback to improve 5A's tobacco cessation in primary care: a cluster randomized clinical trial. Nicotine Tob Res. 2007 Mar;9(3):341-9. doi: 10.1080/14622200701188828.
Coleman T. Do financial incentives for delivering health promotion counselling work? Analysis of smoking cessation activities stimulated by the quality and outcomes framework. BMC Public Health. 2010 Mar 26;10:167. doi: 10.1186/1471-2458-10-167.
Curry SJ, Keller PA, Orleans CT, Fiore MC. The role of health care systems in increased tobacco cessation. Annu Rev Public Health. 2008;29:411-28. doi: 10.1146/annurev.publhealth.29.020907.090934.
Curry SJ. Organizational interventions to encourage guideline implementation. Chest. 2000 Aug;118(2 Suppl):40S-46S. doi: 10.1378/chest.118.2_suppl.40s.
Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.
Fagan P, Moolchan ET, Lawrence D, Fernander A, Ponder PK. Identifying health disparities across the tobacco continuum. Addiction. 2007 Oct;102 Suppl 2:5-29. doi: 10.1111/j.1360-0443.2007.01952.x.
Clinical Practice Guideline Treating Tobacco Use and Dependence 2008 Update Panel, Liaisons, and Staff. A clinical practice guideline for treating tobacco use and dependence: 2008 update. A U.S. Public Health Service report. Am J Prev Med. 2008 Aug;35(2):158-76. doi: 10.1016/j.amepre.2008.04.009.
Gordon JS, Andrews JA, Albert DA, Crews KM, Payne TJ, Severson HH. Tobacco cessation via public dental clinics: results of a randomized trial. Am J Public Health. 2010 Jul;100(7):1307-12. doi: 10.2105/AJPH.2009.181214. Epub 2010 May 13.
Gordon JS, Andrews JA, Lichtenstein E, Severson HH. The impact of a brief tobacco-use cessation intervention in public health dental clinics. J Am Dent Assoc. 2005 Feb;136(2):179-86; quiz 230-1. doi: 10.14219/jada.archive.2005.0139.
Gordon JS, Lichtenstein E, Severson HH, Andrews JA. Tobacco cessation in dental settings: research findings and future directions. Drug Alcohol Rev. 2006 Jan;25(1):27-37. doi: 10.1080/09595230500459495.
Fiore MC, Keller PA, Curry SJ. Health system changes to facilitate the delivery of tobacco-dependence treatment. Am J Prev Med. 2007 Dec;33(6 Suppl):S349-56. doi: 10.1016/j.amepre.2007.09.001.
Greenhalgh T, Robert G, Macfarlane F, Bate P, Kyriakidou O. Diffusion of innovations in service organizations: systematic review and recommendations. Milbank Q. 2004;82(4):581-629. doi: 10.1111/j.0887-378X.2004.00325.x.
Grimshaw J, Eccles M, Thomas R, MacLennan G, Ramsay C, Fraser C, Vale L. Toward evidence-based quality improvement. Evidence (and its limitations) of the effectiveness of guideline dissemination and implementation strategies 1966-1998. J Gen Intern Med. 2006 Feb;21 Suppl 2(Suppl 2):S14-20. doi: 10.1111/j.1525-1497.2006.00357.x.
Institute of Medicine (US) Committee on Crossing the Quality Chasm: Adaptation to Mental Health and Addictive Disorders. Improving the Quality of Health Care for Mental and Substance-Use Conditions: Quality Chasm Series. Washington (DC): National Academies Press (US); 2006. Available from http://www.ncbi.nlm.nih.gov/books/NBK19830/
Centers for Disease Control and Prevention (CDC). Vital signs: current cigarette smoking among adults aged >or=18 years --- United States, 2009. MMWR Morb Mortal Wkly Rep. 2010 Sep 10;59(35):1135-40.
Lopez-Quintero C, Crum RM, Neumark YD. Racial/ethnic disparities in report of physician-provided smoking cessation advice: analysis of the 2000 National Health Interview Survey. Am J Public Health. 2006 Dec;96(12):2235-9. doi: 10.2105/AJPH.2005.071035. Epub 2006 Jun 29.
Manski RJ, Cooper PF. Dental care use: does dental insurance truly make a difference in the US? Community Dent Health. 2007 Dec;24(4):205-12.
Petersen LA, Woodard LD, Urech T, Daw C, Sookanan S. Does pay-for-performance improve the quality of health care? Ann Intern Med. 2006 Aug 15;145(4):265-72. doi: 10.7326/0003-4819-145-4-200608150-00006.
Ramseier CA, Warnakulasuriya S, Needleman IG, Gallagher JE, Lahtinen A, Ainamo A, Alajbeg I, Albert D, Al-Hazmi N, Antohe ME, Beck-Mannagetta J, Benzian H, Bergstrom J, Binnie V, Bornstein M, Buchler S, Carr A, Carrassi A, Casals Peidro E, Chapple I, Compton S, Crail J, Crews K, Davis JM, Dietrich T, Enmark B, Fine J, Gallagher J, Jenner T, Forna D, Fundak A, Gyenes M, Hovius M, Jacobs A, Kinnunen T, Knevel R, Koerber A, Labella R, Lulic M, Mattheos N, McEwen A, Ohrn K, Polychronopoulou A, Preshaw P, Radley N, Rosseel J, Schoonheim-Klein M, Suvan J, Ulbricht S, Verstappen P, Walter C, Warnakulasuriya S, Wennstrom J, Wickholm S, Zoitopoulos L. Consensus Report: 2nd European Workshop on Tobacco Use Prevention and Cessation for Oral Health Professionals. Int Dent J. 2010 Feb;60(1):3-6.
Roski J, Jeddeloh R, An L, Lando H, Hannan P, Hall C, Zhu SH. The impact of financial incentives and a patient registry on preventive care quality: increasing provider adherence to evidence-based smoking cessation practice guidelines. Prev Med. 2003 Mar;36(3):291-9. doi: 10.1016/s0091-7435(02)00052-x.
Solberg LI. Improving medical practice: a conceptual framework. Ann Fam Med. 2007 May-Jun;5(3):251-6. doi: 10.1370/afm.666.
Solberg LI, Brekke ML, Fazio CJ, Fowles J, Jacobsen DN, Kottke TE, Mosser G, O'Connor PJ, Ohnsorg KA, Rolnick SJ. Lessons from experienced guideline implementers: attend to many factors and use multiple strategies. Jt Comm J Qual Improv. 2000 Apr;26(4):171-88. doi: 10.1016/s1070-3241(00)26013-6.
Sonnad SS. Organizational tactics for the successful assimilation of medical practice guidelines. Health Care Manage Rev. 1998 Summer;23(3):30-7. doi: 10.1097/00004010-199802330-00004.
Strauss SM, Alfano MC, Shelley D, Fulmer T. Identifying unaddressed systemic health conditions at dental visits: patients who visited dental practices but not general health care providers in 2008. Am J Public Health. 2012 Feb;102(2):253-5. doi: 10.2105/AJPH.2011.300420. Epub 2011 Dec 15.
Tong EK, Strouse R, Hall J, Kovac M, Schroeder SA. National survey of U.S. health professionals' smoking prevalence, cessation practices, and beliefs. Nicotine Tob Res. 2010 Jul;12(7):724-33. doi: 10.1093/ntr/ntq071. Epub 2010 May 27.
Wadland WC, Holtrop JS, Weismantel D, Pathak PK, Fadel H, Powell J. Practice-based referrals to a tobacco cessation quit line: assessing the impact of comparative feedback vs general reminders. Ann Fam Med. 2007 Mar-Apr;5(2):135-42. doi: 10.1370/afm.650.
Ajzen I. The theory of planned behaviour: reactions and reflections. Psychol Health. 2011 Sep;26(9):1113-27. doi: 10.1080/08870446.2011.613995.
Ostroff JS, Li Y, Shelley DR. 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. Implement Sci. 2014 Feb 21;9:25. doi: 10.1186/1748-5908-9-25.
Primary Completion
December 8, 2018
Actual (reported)Study Completion
December 8, 2018
Actual (reported)Last Updated
February 15, 2019
Record last verified: 2019-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: