Embedding comprehensive smoking cessation programs into community clinics: study protocol for a cluster-randomized controlled trial

Wave-Ananda Baskerville, Theodore C Friedman, Brian Hurley, Susan Hsieh, Tasha Dixon, Norma Mtume, Martin L Lee, Luz Rodriguez, Briana Lopez, Lara A Ray, Wave-Ananda Baskerville, Theodore C Friedman, Brian Hurley, Susan Hsieh, Tasha Dixon, Norma Mtume, Martin L Lee, Luz Rodriguez, Briana Lopez, Lara A Ray

Abstract

Background: Cigarette smoking among adults in the USA is a leading cause of preventable death worldwide, even though there has been a decline in prevalence since 2005. The addictive nature of nicotine is the chief reason smokers continue to use tobacco. Although the majority of smokers report a desire to quit smoking, a small minority who attempt to quit achieve long-term cessation. Combined, smoking cessation best practices include coordinated medication and behavioral treatments. However, these treatments are not currently adequately delivered to Medi-Cal beneficiaries in the publicly funded patient-centered medical homes (PCMHs) and community mental health clinics operated by Los Angeles County (LAC)-Department of Health Services (LACDHS) and LAC-Department of Mental Health (LACDMH).

Methods: This is a 5-year implementation, cluster-randomized comparative effectiveness trial that will support the implementation of smoking cessation services delivered in LAC-LACDHS-operated outpatient primary care clinics and in LAC-LACDMH-operated community mental health clinics. We will enroll 1000 participants from clinics that will offer smoking cessation services and 200 from clinics that will offer treatment as usual. Participants will be asked to complete assessments at baseline, 3 months, 6 months, and 12 months. The assessments will include self-reports on smoking history, anxiety, stress, quality of life, and participant satisfaction. Participants who are assigned to clinics that provide smoking cessation services will also be asked about the frequency of their participation in the smoking cessation services during the 12-month period.

Discussion: This study will evaluate the effectiveness and feasibility of implementing smoking cessation services in outpatient primary care and community mental health clinics. It will also determine if there will be higher rates of smoking cessation in the implementation sites as compared to the sites with treatment as usual. If the implementation proves to be effective, the plan is to sustain these services using a workflow we will develop in the LAC-operated sites. This would lead to ameliorating the significant smoking cessation treatment gaps among those served within the LAC Health Agency departments.

Trial registration: ClinicalTrials.gov NCT04717544 "Embedding comprehensive smoking cessation programs into community clinics." Registered on January 22, 2021.

Keywords: Cigarette use; Community clinics; Smoking; Smoking cessation programs; Treatment.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Flow diagram illustrating participant’s timeline through the trial

References

    1. Creamer MR, Wang TW, Babb S, Cullen KA, Day H, Willis G, et al. Tobacco product use and cessation indicators among adults — United States, 2018. Morb Mortal Wkly Rep. 2019;68(45):1013–1019. doi: 10.15585/mmwr.mm6845a2.
    1. CDCTobaccoFree. Best practices for comprehensive tobacco control programs—2014 [Internet]. Centers Dis Control Prev. 2020; Available from: . Accessed 13 Dec 2020.
    1. Jamal A. Current cigarette smoking among adults — United States, 2016. MMWR Morb Mortal Wkly Rep [Internet]. 2018;67 Available from: . Accessed 13 Dec 2020.
    1. Mackowick KM, Lynch M-J, Weinberger AH, George TP. Treatment of tobacco dependence in people with mental health and addictive disorders. Curr Psychiatr Rep. 2012;14(5):478–485. doi: 10.1007/s11920-012-0299-2.
    1. Ziedonis D, Hitsman B, Beckham JC, Zvolensky M, Adler LE, Audrain-McGovern J, Breslau N, Brown RA, George TP, Williams J, Calhoun PS, Riley WT. Tobacco use and cessation in psychiatric disorders: National Institute of Mental Health report. Nicotine Tob Res. 2008;10(12):1691–1715. doi: 10.1080/14622200802443569.
    1. Centers for Disease Control and Prevention (CDC) Quitting smoking among adults--United States, 2001-2010. MMWR Morb Mortal Wkly Rep. 2011;60(44):1513–1519.
    1. Cahill K, Stevens S, Perera R, Lancaster T. Pharmacological interventions for smoking cessation: an overview and network meta-analysis. Cochrane Database Syst Rev [Internet]. 2013;5(5) Available from: . Accessed 13 Dec 2020.
    1. Fiore MC, Fleming MF, Burns ME. Tobacco and alcohol abuse: clinical opportunities for effective intervention. Proc Assoc Am Phys. 1999;111(2):131–140. doi: 10.1046/j.1525-1381.1999.09249.x.
    1. Stead LF, Carroll AJ, Lancaster T. Group behaviour therapy programmes for smoking cessation. Cochrane Tobacco Addiction Group, editor. Cochrane Database Syst Rev [Internet]. 2017; Available from: ;3.
    1. Los Angeles County (Calif.). Public Health. Key indicators of health by service planning area. Los Angeles: County Department of Health Services; 2003.
    1. Elwyn G, Dehlendorf C, Epstein RM, Marrin K, White J, Frosch DL. Shared decision making and motivational interviewing: achieving patient-centered care across the spectrum of health care problems. Ann Fam Med. 2014;12(3):270–275. doi: 10.1370/afm.1615.
    1. Friedrichs A, Spies M, Härter M, Buchholz A. Patient preferences and shared decision making in the treatment of substance use disorders: a systematic review of the literature. Fischer G, editor. PLoS ONE. 2016;11(1):e0145817. doi: 10.1371/journal.pone.0145817.
    1. Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988;56(6):893–897. doi: 10.1037/0022-006X.56.6.893.
    1. Beck AT, Steer RA, Ball R, Ranieri WF. Comparison of beck depression inventories-IA and-II in psychiatric outpatients. J Pers Assess. 1996;67(3):588–597. doi: 10.1207/s15327752jpa6703_13.
    1. Fagerstrom KO, Schneider NG. Measuring nicotine dependence: a review of the Fagerstrom Tolerance Questionnaire. J Behav Med. 1989;12(2):159–182. doi: 10.1007/BF00846549.
    1. Hughes JR. Signs and symptoms of tobacco withdrawal. Arch Gen Psychiatr. 1986;43(3):289. doi: 10.1001/archpsyc.1986.01800030107013.
    1. Bolt DM, Piper ME, McCarthy DE, Japuntich SJ, Fiore MC, Smith SS, et al. The Wisconsin Predicting Patients’ Relapse questionnaire. Nicotine Tob Res. 2009;11(5):481–492. doi: 10.1093/ntr/ntp030.
    1. Sobell LC, Sobell MB. Timeline Follow-Back. In: Litten RZ, Allen JP, editors. Measuring alcohol consumption: psychosocial and biochemical methods [Internet] Totowa, NJ: Humana Press; 1992. pp. 41–72.
    1. Cox LS, Tiffany ST, Christen AG. Evaluation of the brief questionnaire of smoking urges (QSU-brief) in laboratory and clinical settings. Nicotine Tob Res. 2001;3(1):7–16. doi: 10.1080/14622200020032051.
    1. Marshall GN, Hays RD. The patient satisfaction questionnaire short-form (PSQ-18). Rand Santa Monica: RAND; 1994.
    1. Anthenelli RM, Benowitz NL, West R, St Aubin L, McRae T, Lawrence D, Ascher J, Russ C, Krishen A, Evins AE. Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo-controlled clinical trial. Lancet. 2016;387(10037):2507–2520. doi: 10.1016/S0140-6736(16)30272-0.

Source: PubMed

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