Proactive outreach for smokers using VHA mental health clinics: protocol for a patient-randomized clinical trial

BMC Public Health

Scott E Sherman⁴  Carolyn Schlede²  Radha Rao¹  Sean M Nugent⁵  Siamak Noorbaloochi⁵  Paul Krebs⁴  Steven S Fu³  Erin S Rogers⁴ 

[1] Michael E. DeBakey VHA Medical Center, 2002 Holcombe Blvd, Houston, TX 77030, USA;James A. Haley Veterans’ Hospital, 13000 Bruce B. Downs Blvd, Tampa, FL 33612, USA;Department of Medicine, University of Minnesota Medical School, 717 SE Delaware St, Minneapolis, MN 55414, USA;Department of Population Health, New York University School of Medicine, 227 East 30th Street, New York, NY 10016, USA;VA HSR&D Center for Chronic Disease Outcomes Research (CCDOR), Minneapolis VHA Health Care System, One Veterans Drive, Minneapolis, MN 55417, USA

关键词: Mental health;    Smoking cessation;    Tobacco;    Smoking;   

Others  :  1091974
DOI  :  10.1186/1471-2458-14-1294

 received in 2014-11-03, accepted in 2014-12-01,  发布年份 2014

【 摘 要 】

Background

Persons with a mental health diagnosis have high rates of tobacco use and face numerous barriers to cessation including high levels of nicotine dependence, low rates of tobacco treatment referrals from mental health providers, and limited availability of tobacco treatment targeted to their needs. This manuscript describes the rationale and methods of a clinical trial with the following aims: 1) Compare the reach and efficacy of a proactive telephone-based tobacco cessation program for Veterans Health Administration (VHA) mental health clinic patients to VHA usual care and 2) Model longitudinal associations between baseline patient characteristics and long-term abstinence.

Methods/design

We will use the electronic medical record to identify patients across four VHA healthcare facilities who have a clinical reminder code indicating current tobacco use in the past six months and who have had a mental health clinic visit in the past 12 months. We will send each patient an introductory letter and baseline survey. Survey respondents (N = 3840) will be randomized in a 1:1 fashion to intervention or control. Control participants will receive VHA usual care. Intervention participants will receive proactive motivational telephone outreach to offer tobacco treatment. Intervention participants interested in treatment will receive eight weeks of nicotine replacement therapy plus eight sessions of specialized telephone counseling over two months, followed by monthly maintenance counseling for four months. We will conduct telephone surveys with participants at six and 12 months to assess study outcomes. We will collect a mailed saliva sample from patients reporting 7-day abstinence on the telephone surveys. The primary outcome will be cotinine-validated abstinence at 12-month follow-up.

Discussion

Mental health patients are a high-risk smoking population with significant barriers to cessation. This study will evaluate the efficacy of a program that proactively reaches out to smokers with a mental health treatment history to engage them into telephone cessation counseling targeted to the needs of mental health patients.

Trial registration

Clinicaltrials.gov: NCT01737281 (registered November 5, 2012).

【 授权许可】

   
2014 Rogers et al.; licensee BioMed Central.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]US Department of Health and Human Services: The health consequences of smoking–50 years of progress: a report of the surgeon general. Atlanta: US Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; 2014.
• [2]Grant BF, Hasin DS, Chou SP, Stinson FS, Dawson DA: Nicotine dependence and psychiatric disorders in the United States: results from the national epidemiologic survey on alcohol and related conditions. Arch Gen Psychiatry 2004, 61(11):1107-1115.
• [3]Lasser K, Boyd JW, Woolhandler S, Himmelstein DU, McCormick D, Bor DH: Smoking and mental illness: a population-based prevalence study. JAMA 2000, 284(20):2606-2610.
• [4]McCreadie RG, Scottish Comorbidity Study G: Use of drugs, alcohol and tobacco by people with schizophrenia: case–control study. Br J Psychiatry 2002, 181:321-325.
• [5]Beckham JC, Lytle BL, Vrana SR, Hertzberg MA, Feldman ME, Shipley RH: Smoking withdrawal symptoms in response to a trauma-related stressor among Vietnam combat veterans with posttraumatic stress disorder. Addict Behav 1996, 21(1):93-101.
• [6]Addington J, El-Guebaly N, Addington D, Hodgins D: Readiness to stop smoking in schizophrenia. Can J Psychiatr 1997, 42(1):49-52.
• [7]Etter M, Mohr S, Garin C, Etter JF: Stages of change in smokers with schizophrenia or schizoaffective disorder and in the general population. Schizophr Bull 2004, 30(2):459-468.
• [8]Green MA, Clarke DE: Smoking reduction and cessation: a hospital-based survey of outpatients’ attitudes. J Psychosoc Nurs Ment Health Serv 2005, 43(5):18-25.
• [9]Prochaska J, Rossi J, Redding C: Depressed smokers and stage of change: implications for treatment interventions. Drug Alcohol Depend 2004, 76(2):143-151.
• [10]Schroeder SA, Morris CD: Confronting a neglected epidemic: tobacco cessation for persons with mental illnesses and substance abuse problems. Annu Rev Public Health 2010, 31:297-314. 291p following 314
• [11]Mobascher A, Winterer G: The molecular and cellular neurobiology of nicotine abuse in schizophrenia. Pharmacopsychiatry 2008, 41(Suppl 1):S51-S59.
• [12]Dolan SL, Sacco KA, Termine A, Seyal AA, Dudas MM, Vessicchio JC, Wexler BE, George TP: Neuropsychological deficits are associated with smoking cessation treatment failure in patients with schizophrenia. Schizophr Res 2004, 70(2–3):263-275.
• [13]Sacco KA, Termine A, Seyal A, Dudas MM, Vessicchio JC, Krishnan-Sarin S, Jatlow PI, Wexler BE, George TP: Effects of cigarette smoking on spatial working memory and attentional deficits in schizophrenia: involvement of nicotinic receptor mechanisms. Arch Gen Psychiatry 2005, 62(6):649-659.
• [14]Brown RA, Lejuez CW, Strong DR, Kahler CW, Zvolensky MJ, Carpenter LL, Niaura R, Price LH: A prospective examination of distress tolerance and early smoking lapse in adult self-quitters. Nicotine Tob Res 2009, 11(5):493-502.
• [15]Hitsman B, Moss TG, Montoya ID, George TP: Treatment of tobacco dependence in mental health and addictive disorders. Can J Psychiatr 2009, 54(6):368-378.
• [16]Gelenberg A, de Leon J, Evins A: Smoking cessation in patients with psychiatric disorders. J Clin Psychiatry 2008, 10(1):52-58.
• [17]Thorndike AN, Stafford RS, Rigotti NA: US physicians’ treatment of smoking in outpatients with psychiatric diagnoses. Nicotine Tob Res 2001, 3(1):85-91.
• [18]Cohen DJ, Tallia AF, Crabtree BF, Young DM: Implementing health behavior change in primary care: lessons from prescription for health. Ann Fam Med 2005, 3(Suppl 2):S12-S19.
• [19]Rogers E, Sherman S: Tobacco use screening and treatment by outpatient psychiatrists before and after release of the American Psychiatric Association treatment guidelines for nicotine dependence. Am J Public Health 2014, 104(1):90-95.
• [20]Richter KP, McCool RM, Okuyemi KS, Mayo MS, Ahluwalia JS: Patients’ views on smoking cessation and tobacco harm reduction during drug treatment. Nicotine Tob Res 2002, 4(Suppl 2):S175-S182.
• [21]Fu SS, van Ryn M, Sherman SE, Burgess DJ, Noorbaloochi S, Clothier B, Taylor BC, Schlede CM, Burke RS, Joseph AM: Proactive tobacco treatment and population-level cessation: a pragmatic randomized clinical trial. JAMA Intern Med 2014, 174(5):671-677.
• [22]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(12):1233-1239.
• [23]Dillman DA: Mail and internet surveys: the tailored design method. New York: Wiley & Son; 2000.
• [24]Rogers ES: FS KD, Smelson D, De Torrijos F, Sherman SE: TeleQuit Mental Health counseling manual. New York, NY: Department of Veterans Affairs; 2009.
• [25]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, 35(2):158-176.
• [26]Davis JM, Fleming MF, Bonus KA, Baker TB: A pilot study on mindfulness based stress reduction for smokers. BMC Complement Altern Med 2007, 7:2. BioMed Central Full Text
• [27]Brewer JA, Mallik S, Babuscio TA, Nich C, Johnson HE, Deleone CM, Minnix-Cotton CA, Byrne SA, Kober H, Weinstein AJ, Carroll KM, Rounsaville BJ: Mindfulness training for smoking cessation: Results from a randomized controlled trial. Drug Alcohol Depend 2011, 119(1–2):72-80.
• [28]Cinciripini PM, Wetter DW, McClure JB: Scheduled reduced smoking: effects on smoking abstinence and potential mechanisms of action. Addict Behav 1997, 22(6):759-767.
• [29]University of San Diego: California Tobacco Surveys. 1999. http://libraries.ucsd.edu/resources/data-gov-info-gis/ssds/guides/tobacco-surveys.html webcite. Accessed Feb, 2002
• [30]Heatherton TF, Kozlowski LT, Frecker RC, Rickert W: Robinson : Measuring the heaviness of smoking: Using self-reported time to the 1st cigarette of the day and number of cigarettes smoked per day. Br J Addiction 1989, 84(7):791-800.
• [31]Velicer WF, Fava JL, Prochaska JO, Abrams DB, Emmons KM, Pierce JP: Distribution of smokers by stage in three representative samples. Prev Med 1995, 24(4):401-411.
• [32]Frank D, DeBenedetti AF, Volk RJ, Williams EC, Kivlahan DR, Bradley KA: Effectiveness of the AUDIT-C as a screening test for alcohol misuse in three race/ethnic groups. J Gen Intern Med 2008, 23(6):781-787.
• [33]Bush K, Kivlahan DR, McDonell MB, Fihn SD, Bradley KA: Ambulatory Care Quality Improvement P: The AUDIT alcohol consumption questions (AUDIT-C) - An effective brief screening test for problem drinking. Arch Intern Med 1998, 158(16):1789-1795.
• [34]Kessler RC, Green JG, Gruber MJ, Sampson NA, Bromet E, Cuitan M, Furukawa TA, Gureje O, Hinkov H, Hu CY, Lara C, Lee S, Mneimneh Z, Myer L, Oakley-Browne M, Posada-Villa J, Sagar R, Viana MC, Zaslavsky AM: Screening for serious mental illness in the general population with the K6 screening scale: results from the WHO World Mental Health (WMH) survey initiative. Int J Methods Psychiatr Res 2010, 19 Suppl 1:4-22.
• [35]McGuire LC, Strine TW, Allen RS, Anderson LA, Mokdad AH: The Patient Health Questionnaire 8: current depressive symptoms among U.S. older adults, 2006 Behavioral Risk Factor Surveillance System. Am J Geriatr Psychiatry 2009, 17(4):324-334.
• [36]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(1):13-25.
• [37]Velicer WF, Prochaska JO, Rossi JS, Snow MG: Assessing outcome in smoking cessation studies. Psychol Bull 1992, 111(1):23-41.
• [38]SRNT: Subcommittee on biochemical verification: Biochemical verification of tobacco use and cessation. Nicotine Tob Res 2002, 4(2):149-159.
• [39]Bryk A, Raudenbush S: Hierarchical linear models: Applications and data analysis methods. Newbury Park, CA: Sage; 1992.
• [40]Hedeker DR, Bibbons RD: Longitudinal data analysis. Hoboken, NJ: John Wiley & Sons; 2006.
• [41]Nelson D, Partin M, Fu S, Joseph A, An L: Why assigning ongoing tobacco use is not necessarily a conservative approach to handling missing tobacco cessation outcomes. Nicotine Tob Res 2009, 11(1):77-83.
• [42]Little RJ, Yosef M, Cain KC, Nan B, Harlow SD: A hot-deck multiple imputation procedure for gaps in longitudinal data on recurrent currents. Stat Med 2008, 27(1):103-120.
• [43]Solberg LI, Maciosek MV, Edwards NM, Khanchandani HS, Goodman MJ: Repeated tobacco-use screening and intervention in clinical practice. Health impact and cost effectiveness. Am J Prev Med 2006, 31(1):62-71. e63