Tailored Versus Generic Knowledge Brokering to Integrate Mood Management Into Smoking Cessation Interventions in Primary Care Settings: Protocol for a Cluster Randomized Controlled Trial

Nadia Minian, Aliya Noormohamed, Dolly Baliunas, Laurie Zawertailo, Carol Mulder, Arun Ravindran, Claire de Oliveira, Peter Selby, Nadia Minian, Aliya Noormohamed, Dolly Baliunas, Laurie Zawertailo, Carol Mulder, Arun Ravindran, Claire de Oliveira, Peter Selby

Abstract

Background: Both tobacco smoking and depression are major public health problems associated with high morbidity and mortality. In addition, individuals with depression are almost twice as likely to smoke and less likely to achieve smoking cessation. In the Smoking Treatment for Ontario Patients program, an established smoking cessation program in Ontario, Canada, 38% of smokers in primary care settings have current or past depression with 6-month quit rates that are significantly lower than those without depression (33% versus 40%, P<.001). Integrating self-help mood management (eg, relaxation exercises and mood monitoring) with smoking cessation treatment increases long-term quit rates by 12%-20%. However, integration in real-world settings has not been reported. It is unclear which knowledge translation strategy would be more effective for motivating clinicians to provide resources on mood management to eligible patients.

Objective: The objectives of this study are to investigate the following comparisons among depressed smokers enrolled in a smoking cessation program: 1) the effectiveness of generalized, exclusively email-based prompts versus a personalized knowledge broker in implementing mood management interventions; 2) the effectiveness of the two knowledge translation strategies on smoking quit rates; and 3) the incremental costs of the two knowledge translation strategies on the implementation of mood management interventions.

Methods: The study design is a cluster randomized controlled trial of Family Health Teams participating in the Smoking Treatment for Ontario Patients program. Family Health Teams will be randomly allocated 1:1 to receive either generalized messages (related to depression and smoking) exclusively via email (group A) or be assigned a knowledge broker who provides personalized support through phone- and email-based check-ins (group B). The primary outcome, measured at the site level, is the proportion of eligible baseline visits that result in the provision of the mood management intervention to eligible patients.

Results: Recruitment for the primary outcome of this study will be completed in 2018/2019. Results will be reported in 2019/2020.

Conclusions: This study will address the knowledge gap in the implementation strategies (ie, email-based prompts versus a knowledge broker) of mood management interventions for smokers with depression in primary care settings.

Trial registration: ClinicalTrials.gov NCT03130998; https://ichgcp.net/clinical-trials-registry/NCT03130998 (Archived on WebCite at www.webcitation.org/6ylyS6RTe)

Keywords: tobacco; depression; health care practitioner; primary health care; knowledge broker; clinical decision support system; screening; brief intervention; integrated care pathways.

Conflict of interest statement

None declared.

©Nadia Minian, Aliya Noormohamed, Dolly Baliunas, Laurie Zawertailo, Carol Mulder, Arun Ravindran, Claire de Oliveira, Peter Selby. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 27.04.2018.

Figures

Figure 1
Figure 1
Study workflow diagram.

References

    1. Hitsman B, Papandonatos G, McChargue D, DeMott A, Herrera M, Spring B, Borrelli B, Niaura Raymond. Past major depression and smoking cessation outcome: a systematic review and meta-analysis update. Addiction. 2013 Feb;108(2):294–306. doi: 10.1111/add.12009.
    1. Weinberger AH, Pilver CE, Desai RA, Mazure CM, McKee SA. The relationship of major depressive disorder and gender to changes in smoking for current and former smokers: longitudinal evaluation in the US population. Addiction. 2012 Oct;107(10):1847–56. doi: 10.1111/j.1360-0443.2012.03889.x.
    1. Blalock JA, Robinson JD, Wetter DW, Schreindorfer LS, Cinciripini PM. Nicotine withdrawal in smokers with current depressive disorders undergoing intensive smoking cessation treatment. Psychol Addict Behav. 2008 Mar;22(1):122–8. doi: 10.1037/0893-164X.22.1.122.
    1. Kahler CW, Brown RA, Ramsey SE, Niaura R, Abrams DB, Goldstein MG, Mueller TI, Miller IW. Negative mood, depressive symptoms, and major depression after smoking cessation treatment in smokers with a history of major depressive disorder. J Abnorm Psychol. 2002 Nov;111(4):670–5.
    1. Hall SM, Prochaska Judith J. Treatment of smokers with co-occurring disorders: emphasis on integration in mental health and addiction treatment settings. Annu Rev Clin Psychol. 2009;5:409–31. doi: 10.1146/annurev.clinpsy.032408.153614.
    1. Kalman D, Morissette SB, George Tony P. Co-morbidity of smoking in patients with psychiatric and substance use disorders. Am J Addict. 2005;14(2):106–23. doi: 10.1080/10550490590924728.
    1. Lasser K, Boyd J, Woolhandler S, Himmelstein D, McCormick D, Bor D. Smoking and mental illness: A population-based prevalence study. JAMA. 2000;284(20):A.
    1. Bolam B, West R. Gunnell D: Does smoking cessation cause depression and anxiety? Findings from the ATTEMPT cohort. Nicotine & Tobacco Research : Official Journal of the Society for Research on Nicotine and Tobacco. 2011;13(3):209–214. doi: 10.1093/ntr/ntq244.
    1. Gierisch J, Bastian L, Calhoun P, McDuffie J, Williams J. Smoking cessation interventions for patients with depression: A systematic review and meta-analysis. J Gen Inter Med. 2012;27(3):A. doi: 10.1007/s11606-011-1915-2.
    1. Torres LD, Barrera AZ, Delucchi K, Penilla C, Pérez-Stable EJ, Muñoz RF. Quitting smoking does not increase the risk of major depressive episodes among users of Internet smoking cessation interventions. Psychol Med. 2010 Mar;40(3):441–9. doi: 10.1017/S0033291709990560.
    1. Weinberger A, Mazure C, Morlett A, McKee Sherry A. Two decades of smoking cessation treatment research on smokers with depression: 1990-2010. Nicotine Tob Res. 2013 Jun;15(6):1014–31. doi: 10.1093/ntr/nts213.
    1. Prochaska J, Hall S, Tsoh J, Eisendrath S, Rossi J, Redding C, Rosen A, Meisner M, Humfleet G, Gorecki Julie A. Treating tobacco dependence in clinically depressed smokers: effect of smoking cessation on mental health functioning. Am J Public Health. 2008 Mar;98(3):446–8. doi: 10.2105/AJPH.2006.101147.
    1. Thorsteinsson H S, Gillin J C, Patten C A, Golshan S, Sutton L D, Drummond S, Clark C P, Kelsoe J, Rapaport M. The effects of transdermal nicotine therapy for smoking cessation on depressive symptoms in patients with major depression. Neuropsychopharmacology. 2001 Apr;24(4):350–8. doi: 10.1016/S0893-133X(00)00217-7. doi: 10.1016/S0893-133X(00)00217-7.
    1. Tsoh J Y, Humfleet G L, Muñoz R F, Reus V I, Hartz D T, Hall S M. Development of major depression after treatment for smoking cessation. Am J Psychiatry. 2000 Mar;157(3):368–74. doi: 10.1176/appi.ajp.157.3.368.
    1. van DMR, Willemsen M, Smit F, Cuijpers Pim. Smoking cessation interventions for smokers with current or past depression. Cochrane Database Syst Rev. 2013 Aug 21;8(8):CD006102. doi: 10.1002/14651858.CD006102.pub2.
    1. Dobbins M, Robeson P, Ciliska D, Hanna S, Cameron R, O'Mara L, DeCorby K, Mercer Shawna. A description of a knowledge broker role implemented as part of a randomized controlled trial evaluating three knowledge translation strategies. Implement Sci. 2009 Apr 27;4:23. doi: 10.1186/1748-5908-4-23.
    1. Dobbins M, Hanna S, Ciliska D, Manske S, Cameron S, Mercer Sl, O'Mara L, DeCorby K, Robeson P. A randomized controlled trial evaluating the impact of knowledge translation and exchange strategies. Implementation Sci. 2009 Sep 23;4(1):A. doi: 10.1186/1748-5908-4-61.
    1. Grimshaw J, Eccles MP. Is evidence-based implementation of evidence-based care possible? Med J Aust. 2004 Mar 15;180(6 Suppl):S50–1.
    1. Grol R, Grimshaw J. From best evidence to best practice: effective implementation of change in patients' care. The Lancet. 2003 Oct;362(9391):1225–1230. doi: 10.1016/S0140-6736(03)14546-1.
    1. Lavis J, Davies H, Oxman A, Denis J, Golden-Biddle K, Ferlie Ewan. Towards systematic reviews that inform health care management and policy-making. J Health Serv Res Policy. 2005 Jul;10 Suppl 1:35–48. doi: 10.1258/1355819054308549.
    1. Government of Canada Family Health Teams. [2018-04-18].
    1. Drzensky F, Egold N, van Dick R. Ready for a Change? A Longitudinal Study of Antecedents, Consequences and Contingencies of Readiness for Change. Journal of Change Management. 2012 Mar;12(1):95–111. doi: 10.1080/14697017.2011.652377.
    1. Blase K, Kiser L, Van Dyke M. The Hexagon Tool: Exploring Context. Chapel Hill, NC: National Implementation Research Network; 2013.
    1. Scaccia Jonathan P, Cook Brittany S, Lamont Andrea, Wandersman Abraham, Castellow Jennifer, Katz Jason, Beidas Rinad S. A practical implementation science heuristic for organizational readiness: R=MC. J Community Psychol. 2015 Apr;43(4):484–501. doi: 10.1002/jcop.21698.
    1. Herie Marilyn, Connolly Hillary, Voci Sabrina, Dragonetti Rosa, Selby Peter. Changing practitioner behavior and building capacity in tobacco cessation treatment: the TEACH project. Patient Educ Couns. 2012 Jan;86(1):49–56. doi: 10.1016/j.pec.2011.04.018.
    1. Nicotine Dependence Clinic Training Enhancement in Applied Cessation Counselling and Health. TEACH. 2011
    1. Spitzer R L, Kroenke K, Williams J B. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999 Nov 10;282(18):1737–44.
    1. Spitzer R L, Williams J B, Kroenke K, Hornyak R, McMurray J. Validity and utility of the PRIME-MD patient health questionnaire in assessment of 3000 obstetric-gynecologic patients: the PRIME-MD Patient Health Questionnaire Obstetrics-Gynecology Study. Am J Obstet Gynecol. 2000 Sep;183(3):759–69.
    1. Muñoz Ricardo F, Barrera Alinne Z, Delucchi Kevin, Penilla Carlos, Torres Leandro D, Pérez-Stable Eliseo J. International Spanish/English Internet smoking cessation trial yields 20% abstinence rates at 1 year. Nicotine Tob Res. 2009 Sep 10;11(9):1025–34. doi: 10.1093/ntr/ntp090.
    1. Muñoz Ricardo F, Lenert Leslie L, Delucchi Kevin, Stoddard Jacqueline, Perez John E, Penilla Carlos, Pérez-Stable Eliseo J. Toward evidence-based Internet interventions: A Spanish/English Web site for international smoking cessation trials. Nicotine Tob Res. 2006 Feb;8(1):77–87. doi: 10.1080/14622200500431940.
    1. Patten Scott B. Updated CANMAT Guidelines for Treatment of Major Depressive Disorder. Can J Psychiatry. 2016 Sep;61(9):504–5. doi: 10.1177/0706743716660034.
    1. Wong Suzy L, Shields Margot, Leatherdale Scott, Malaison Eric, Hammond David. Assessment of validity of self-reported smoking status. Health Rep. 2012 Mar;23(1):47–53.
    1. Drummond MF, Sculpher MJ, Torrance G, O'Brien B, Stoddart G. Methods for the economic evaluation of health care programmes. Oxford: Oxford University Press; 2005.
    1. Glick HA, Doshi JA, Sonnad SS, Polsky D. Economic Evaluation in Clinical Trials. Oxford: Oxford University Press; 2007.
    1. Campbell MK, Torgerson DJ. Bootstrapping: estimating confidence intervals for cost-effectiveness ratios. QJM:monthly journal of the Association of Physicians. 1999;92(3):177–182. doi: 10.1093/qjmed/92.3.177.
    1. Bachmann Max O, Fairall Lara, Clark Allan, Mugford Miranda. Methods for analyzing cost effectiveness data from cluster randomized trials. Cost Eff Resour Alloc. 2007 Sep 06;5:12. doi: 10.1186/1478-7547-5-12.
    1. Salize Hans Joachim, Merkel Silke, Reinhard Iris, Twardella Dorothee, Mann Karl, Brenner Hermann. Cost-effective primary care-based strategies to improve smoking cessation: more value for money. Arch Intern Med. 2009 Feb 09;169(3):230–5; discussion 235. doi: 10.1001/archinternmed.2008.556.
    1. Smit Eline Suzanne, Evers Silvia M A A, de Vries Hein, Hoving Ciska. Cost-effectiveness and cost-utility of Internet-based computer tailoring for smoking cessation. J Med Internet Res. 2013 Mar 14;15(3):e57. doi: 10.2196/jmir.2059.
    1. Borland R, Yong Hh, O'Connor Rj, Hyland A, Thompson Me. The reliability and predictive validity of the Heaviness of Smoking Index and its two components: Findings from the International Tobacco Control Four Country study. Nicotine & Tobacco Research. 2010 Sep 30;12(Supplement 1):S45–S50. doi: 10.1093/ntr/ntq038.
    1. Rutterford Clare, Copas Andrew, Eldridge Sandra. Methods for sample size determination in cluster randomized trials. Int J Epidemiol. 2015 Jun 14;44(3):1051–67. doi: 10.1093/ije/dyv113.
    1. StataCorp . Stata Statistical Software: Release 12. College Station, TX: StataCorp; 2011.
    1. Haynes B, Haines A. Barriers and bridges to evidence based clinical practice. BMJ. 1998 Jul 25;317(7153):273–6.
    1. Kreuter Matthew W, Wray Ricardo J. Tailored and targeted health communication: strategies for enhancing information relevance. Am J Health Behav. 2003;27 Suppl 3:S227–32.
    1. West R. The clinical significance of “small” effects of smoking cessation treatments. Addiction. 2007 Apr 25;102(4):506–9. doi: 10.1111/j.1360-0443.2007.01750.x.
    1. Kreuter Matthew W, Wray Ricardo J. Tailored and targeted health communication: strategies for enhancing information relevance. Am J Health Behav. 2003;27 Suppl 3:S227–32.
    1. West R: The clinical significance of 'small' effects of smoking cessation treatments. The clinical significance of “small” effects of smoking cessation treatments. Addiction. 2007 Apr;102(4):506–9. doi: 10.1111/j.1360-0443.2007.01750.x.

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