Implementing Tobacco Use Treatment Guidelines in Dental Public Health Clinics

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Memorial Sloan-Kettering Cancer Center
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01615237
First received: June 6, 2012
Last updated: March 5, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Tobacco Cessation
Behavioral: Audit and performance feedback (PF)
Behavioral: Financial Incentive (P4P)
Behavioral: Current Best Practices (CBP)
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Implementing Tobacco Use Treatment Guidelines in Dental Public Health Clinics

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • 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). [ Time Frame: prior to and approximately 12 months following each site's enrollment in the study ] [ Designated as safety issue: No ]
    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.

  • Compare the effectiveness of the three intervention arms on provider behavior for aiding patient's tobacco cessation [ Time Frame: June 2013-June 2017 ] [ Designated as safety issue: No ]

    We will also conduct provider surveys with all participating dentists and dental directors, and semi-structured interviews 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, including the semi-structured interviews 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.



Secondary Outcome Measures:
  • Cost analysis [ Time Frame: last two years of the study/ end of each site's enrollment period ] [ Designated as safety issue: No ]
    We will separate estimate research costs (e.g. labor and other inputs associated with grant administration, Institutional Review Board approval, manuscript prep) and direct clinical intervention costs (e.g. dental provider time associated with counseling patients, staff training, IT costs, reimbursement costs). The New York State Quitline has estimates of their counseling cost per quit. We will also estimate the costs of the medications taken by the patients as part of their cessation attempt (reported at the 3 month telephone survey).

  • assess patient utilization of cessation services and smoking abstinence [ Time Frame: 3 months post clinic visit ] [ Designated as safety issue: No ]
    We will conduct follow-up telephone interviews, three months post clinic visit, with smokers who complete the post intervention PEIs. We will use a standardized interview that we have used successfully to collect patient-reported outcomes in our prior cessation research.


Estimated Enrollment: 4140
Study Start Date: February 2013
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CBP + PF
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.
Behavioral: Audit and performance feedback (PF)
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.
Behavioral: Current Best Practices (CBP)
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.
Active Comparator: CBP + PF + P4P
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.
Behavioral: Audit and performance feedback (PF)
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.
Behavioral: Financial Incentive (P4P)
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.
Behavioral: Current Best Practices (CBP)
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.
Active Comparator: Current Best Practices (CBP)
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.
Behavioral: Current Best Practices (CBP)
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 excluded.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01615237

Locations
United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
New York University School of Medicine
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Donna Shelley, MD, MPH New York University School of Medicine
Principal Investigator: Jamie Ostroff, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01615237     History of Changes
Other Study ID Numbers: 1 R01 CA162035-01A1
Study First Received: June 6, 2012
Last Updated: March 5, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014