Population-based tobacco treatment: study design of a randomized controlled trial

Steven S Fu, Michelle van Ryn, Scott E Sherman, Diana J Burgess, Siamak Noorbaloochi, Barbara Clothier, Anne M Joseph, Steven S Fu, Michelle van Ryn, Scott E Sherman, Diana J Burgess, Siamak Noorbaloochi, Barbara Clothier, Anne M Joseph

Abstract

Background: Most smokers do not receive comprehensive, evidence-based treatment for tobacco use that includes intensive behavioral counseling along with pharmacotherapy. Further, the use of proven, tobacco treatments is lower among minorities than among Whites. The primary objectives of this study are to: (1) Assess the effect of a proactive care intervention (PRO) on population-level smoking abstinence rates (i.e., abstinence among all smokers including those who use and do not utilize treatment) and on utilization of tobacco treatment compared to reactive/usual care (UC) among a diverse population of smokers, (2) Compare the effect of PRO on population-level smoking abstinence rates and utilization of tobacco treatments between African American and White smokers, and (3) Determine the cost-effectiveness of the proactive care intervention.

Methods/design: This prospective randomized controlled trial identifies a population-based sample of current smokers from the Department of Veterans Affairs (VA) electronic medical record health factor dataset. The proactive care intervention combines: (1) proactive outreach and (2) offer of choice of smoking cessation services (telephone or face-to-face). Proactive outreach includes mailed invitation materials followed by an outreach call that encourages smokers to seek treatment with choice of services. Proactive care participants who choose telephone care receive VA telephone counseling and access to pharmacotherapy. Proactive care participants who choose face-to-face care are referred to their VA facility's smoking cessation clinic. Usual care participants have access to standard smoking cessation services from their VA facility (e.g., pharmacotherapy, smoking cessation clinic) and from their state telephone quitline. Baseline data is collected from VA administrative databases and participant surveys. Outcomes from both groups are collected 12 months post-randomization from participant surveys and from VA administrative databases. The primary outcome is self-reported smoking abstinence, which is assessed at the population-level (i.e., among those who utilize and those who do not utilize tobacco treatment). Primary analyses will follow intention-to-treat methodology.

Discussion: This randomized trial is testing proactive outreach strategies offering choice of smoking cessation services, an innovation that if proven effective and cost-effective, will transform the way tobacco treatment is delivered. National dissemination of proactive treatment strategies could dramatically reduce tobacco-related morbidity, mortality, and health care costs.

Clinical trials registration: ClinicalTrials.gov: NCT00608426.

Figures

Figure 1
Figure 1
Study Design and Overview.

References

    1. Fiore MC, Croyle RT, Curry SJ, Cutler CM, Davis RM, Gordon C, Healton C, Koh HK, Orleans CT, Richling D, Satcher D, Seffrin J, Williams C, Williams LN, Keller PA, Baker TB. Preventing 3 million premature deaths and helping 5 million smokers quit: a national action plan for tobacco cessation. Am J Public Health. 2004;94:205–210. doi: 10.2105/AJPH.94.2.205.
    1. Abrams DB, Orleans CT, Niaura RS, Goldstein MG, Prochaska JO. Integrating individual and public health perspectives for tobacco treatment under managed health care: a combined stepped-care and matching model. Ann Behav Med. 1996;18:290–304. doi: 10.1007/BF02895291.
    1. Sherman SE, Talcot W, (Co-Chairs) Veterans Health Administration/Department of Defense Clinical Practice Guideline on Management of Tobacco Use. 2004. . Accessed 2/1/2005.
    1. Cokkinedes VE, Halpern MT, Barbeau EM, Ward E, Thun MJ. Racial and Ethnic Disparities in Smoking Cessation Interventions. Am J Prev Med. 2008;34:404–412. doi: 10.1016/j.amepre.2008.02.003.
    1. McGinnis KA, Brandt CA, Skanderson M, Justice AC, Shahrir S, Butt AA, Brown ST, Freiberg MS, Gibert CL, Goetz MB, Kim JW, Pisani MA, Rimland D, Rodriguez-Barradas MC, Sico JJ, Tindle HA, Crothers K. Validating Smoking Data From the Veteran's Affairs Health Factors Dataset, an Electronic Data Source. Nicotine Tob Res. 2011;13:1233–1239. doi: 10.1093/ntr/ntr206.
    1. Bandura A. Social foundations of thought and action: A social cognitive theory. Englewood Cliffs, NJ: Prentice-Hall; 1986.
    1. Prochaska JO, DiClemente CC. Stages and process of self-change of smoking: Toward an integrative model of change. J Consult Clin Psychol. 1983;51:390–395.
    1. Miller WR, Rollnick S. Motivational interviewing: Preparing people for change. New York: Guilford Press; 2002.
    1. Fu SS, Burgess D, van Ryn M, Hatsukami DK, Solomon J, Joseph AM. Views on smoking cessation methods in ethnic minority communities: a qualitative investigation. Prev Med. 2007;44:235–240. doi: 10.1016/j.ypmed.2006.11.002.
    1. Bansal MA, Cummings KM, Hyland A, Giovino GA. Stop-smoking medications: who uses them, who misuses them, and who is misinformed about them? Nicotine Tob Res. 2004;6(Suppl 3):S303–S310.
    1. Strecher VJ. Computer-tailored smoking cessation materials: a review and discussion. Patient Educ Couns. 1999;36:107–117. doi: 10.1016/S0738-3991(98)00128-1.
    1. An LC, Zhu SH, Nelson DB, Arikian NJ, Nugent S, Partin MR, Joseph AM. Benefits of telephone care over primary care for smoking cessation: a randomized trial. Arch Intern Med. 2006;166:536–542. doi: 10.1001/archinte.166.5.536.
    1. Zhu SH, Anderson CM, Tedeschi GJ, Rosbrook B, Johnson CE, Byrd M, Gutiérrez-Terrell E. Evidence of real-world effectiveness of a telephone quitline for smokers. N Engl J Med. 2002;347:1087–1093. doi: 10.1056/NEJMsa020660.
    1. Dillman DA. Mail and Internet Surveys: The Tailored Design Method. New York, NY: John Wiley & Sons Inc.; 2000.
    1. Hughes JR, Keely JP, Niaura RS, Ossip-Klein DJ, Richmond RL, Swan GE. Measures of abstinence in clinical trials: issues and recommendations. Nicotine Tob Res. 2003;5:13–25.
    1. Bush K, Kivlahan DR, McDonell MB, Fihn SD, Bradley KA. The AUDIT alcohol consumption questions (AUDIT-C): an effective brief screening test for problem drinking. Ambulatory Care Quality Improvement Project (ACQUIP). Alcohol Use Disorders Identification Test. Arch Intern Med. 1998;158:1789–1795. doi: 10.1001/archinte.158.16.1789.
    1. California Adult Tobacco Survey. Accessed 12/8/2011.
    1. Behavioral Risk Factor Surveillance System Questionnaire. Accessed 12/8/2011.
    1. Heatherton TF, Kozlowski LT, Frecker RC, Rickert W, Robinson J. Measuring the heaviness of smoking: using self-reported time to the first cigarette of the day and number of cigarettes smoked per day. Br J Addict. 1989;84:791–799. doi: 10.1111/j.1360-0443.1989.tb03059.x.
    1. Davis RM. Healthcare report cards and tobacco measures. Tob Control. 1997;6(Suppl):S70–S77.
    1. Johnson RL, Saha S, Arbelaez JJ, Beach MC, Cooper LA. Racial and ethnic differences in patient perceptions of bias and cultural competence in health care. J Gen Intern Med. 2004;19:101–110.
    1. Baldwin AS, Rothman AJ, Hertel AW, Linde JA, Jeffery RW, Finch EA, Lando HA. Specifying the determinants of the initiation and maintenance of behavior change: an examination of self-efficacy, satisfaction, and smoking cessation. Health Psychol. 2006;25:626–634.
    1. Dijkstra A, De Vries H. Self-efficacy expectations with regard to different tasks in smoking cessation. Psychol Health. 2000;15:501–511. doi: 10.1080/08870440008402009.
    1. Abrams DB, Niaura RS, Brown RA, Emmons KM, Goldstein MG, Monti PM. The Tobacco Dependence Treatment Handbook. New York: The Guilford Press; 2003.
    1. Biener L, Abrams DB. The Contemplation Ladder: validation of a measure of readiness to consider smoking cessation. Health Psychol. 1991;10:360–365.
    1. Etter JF, Perneger TV. Attitudes toward nicotine replacement therapy in smokers and ex-smokers in the general public. Clin Pharmacol Ther. 2001;69:175–183. doi: 10.1067/mcp.2001.113722.
    1. Pearlin LI, Schooler C. The structure of coping. J Health Soc Behav. 1978;19:2–21. doi: 10.2307/2136319.
    1. Wahl OF. Mental health consumers' experience of stigma. Schizophr Bull. 1999;25:467–478.
    1. Trivedi AN, Ayanian JZ. Perceived discrimination and use of preventive health services. J Gen Intern Med. 2006;21:553–558. doi: 10.1111/j.1525-1497.2006.00413.x.
    1. Kessler RC, Mickelson KD, Williams DR. The prevalence, distribution, and mental health correlates of perceived discrimination in the United States. J Health Soc Behav. 1999;40:208–230. doi: 10.2307/2676349.
    1. Ware JE Jr, Snyder MK, Wright WR, Davies AR. Defining and measuring patient satisfaction with medical care. Eval Program Plann. 1983;6:247–263. doi: 10.1016/0149-7189(83)90005-8.
    1. Lehtonen R, Pahkinen E. Practical Methods for Design and Analysis of Complex Surveys. Chichester: John Wiley & Sons, Inc.; 1995.
    1. Binder DA, Roberts GR. In: Analysis of Survey Data. Skinner C, Chambers R, editor. Chichester, UK: Wiley; 2003. Design-based and Model-based Methods for Estimating Model Parameters; pp. 29–48.
    1. Fiore MC, Jaen CJ, Baker TB, Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Service, Public Health Service; 2008.
    1. Sherman SE, Yano EM, Lanto AB, Simon BF, Rubenstein LV. Smokers' interest in quitting and services received: using practice information to plan quality improvement and policy for smoking cessation. Am J Med Qual. 2005;20:33–39. doi: 10.1177/1062860604273776.
    1. Lichtenstein E, Hollis J. Patient referral to a smoking cessation program: who follows through? J Fam Pract. 1992;34:739–744.
    1. Prochaska JO, Velicer WF, Fava JL, Rossi JS, Tsoh JY. Evaluating a population-based recruitment approach and a stage-based expert system intervention for smoking cessation. Addict Behav. 2001;26:583–602. doi: 10.1016/S0306-4603(00)00151-9.
    1. Curry SJ, McBride C, Grothaus LC, Louie D, Wagner EH. A randomized trial of self-help materials, personalized feedback, and telephone counseling with nonvolunteer smokers. J Consult Clin Psychol. 1995;63:1005–1014.
    1. Boyle RG, Solberg LI, Asche SE, Boucher JL, Pronk NP, Jensen CJ. Offering telephone counseling to smokers using pharmacotherapy. Nicotine Tob Res. 2005;7(Suppl 1):S19–S27.
    1. Holtrop JS, Wadland WC, Vansen S, Weismantel D, Fadel H. Recruiting health plan members receiving pharmacotherapy into smoking cessation counseling. Am J Manag Care. 2005;11:501–507.
    1. Paul CL, Wiggers J, Daly JB, Green S, Walsh RA, Knight J, Girgis A. Direct telemarketing of smoking cessation interventions: will smokers take the call? Addiction. 2004;99:907–913. doi: 10.1111/j.1360-0443.2004.00773.x.

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