Evaluation of the Ottawa Model for Smoking Cessation in Diabetes Education Programs
NCT ID: NCT01980017
Last Updated: 2022-04-20
Study Results
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View full resultsBasic Information
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COMPLETED
NA
313 participants
INTERVENTIONAL
2013-07-31
2017-03-15
Brief Summary
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The purpose of this project is to evaluate the effectiveness of the Ottawa Model for Smoking Cessation (OMSC) intervention in multiple diabetes education programs (DEPs) in Ontario. A two-level recruitment strategy will be employed. Eighteen DEPs will be recruited, and then a consecutive sample of eligible smoker-patients will be recruited from each DEP over a 6-month recruitment period. Investigators want to test the impact of the OMSC intervention on quit rates among smokers with diabetes and pre-diabetes referred to these programs. Investigators will conduct a matched-pair cluster design trial at 18 DEPs in Ontario. These sites will be matched based on number of annual referrals for diabetes education (≤ 500/year or \> 500/year). Within each pair, sites will be allocated randomly to either OMSC intervention or control group. Following randomization, the OMSC program will be implemented at the intervention sites over a 6-month period. Following the implementation period, a consecutive sample of smokers will be recruited from both OMSC intervention and control DEPs over a 6-month recruitment period. It is estimated that this will yield a sample of approximately 445 smokers in each of the OMSC intervention and control groups. The primary outcome will be the biochemically-validated 7-day point prevalence abstinence rate six months after an index visit to the DEP. Secondary outcomes will include: rates of identification and intervention of smokers, and diabetes educators' attitudes, confidence, and perceptions of barriers and facilitators to implementing smoking cessation support as part of routine care.
If proven effective, the OMSC is appropriate for implementation in DEPs across Canada and could have profound impacts on patient and community health.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Wait-Listed Control Group
Usual care for smoking cessation
No interventions assigned to this group
Ottawa Model for Smoking Cessation
Ottawa Model for Smoking Cessation
Ottawa Model for Smoking Cessation
Interventions
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Ottawa Model for Smoking Cessation
Eligibility Criteria
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Inclusion Criteria
* The patient is a current smoker (self-report of daily smoking a minimum of 1 cigarette per day in the 30 days preceding recruitment).
* The patient is aged between 18 years and 80 years.
Exclusion Criteria
* The patient is able to read and understand French or English.
* The patient is able to and willing to provide informed consent.
18 Years
80 Years
ALL
No
Sponsors
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Ottawa Heart Institute Research Corporation
OTHER
Responsible Party
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Principal Investigators
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Robert Reid, PhD., MBA
Role: PRINCIPAL_INVESTIGATOR
Ottawa Heart Institute Research Corporation
Andrew Pipe, MD, FRCPC
Role: STUDY_CHAIR
Ottawa Heart Institute Research Corporation
Oh Paul, MD, FRCPC
Role: STUDY_CHAIR
Toronto Rehabilitation Institute
Anil Gupta, MD, FRCPC
Role: STUDY_CHAIR
Trillium Heath Centre
Kocourek Jana, MA
Role: STUDY_CHAIR
Ottawa Heart Institute Research Corporation
Mullen Kerri-Anne, MSc.
Role: STUDY_CHAIR
Ottawa Heart Institute Research Corporation
Aiken Debbie, BScN
Role: STUDY_CHAIR
Ottawa Heart Institute Research Corporation
Tulloch Heather, Ph.D., Psych.
Role: STUDY_CHAIR
Ottawa Heart Institute Research Corporation
David Arbeau, BA, BTech, RT
Role: STUDY_CHAIR
Horizon Health Network
Malcolm Janine, MD, FRCPC
Role: STUDY_CHAIR
Faculty of Medicine, University of Ottawa
Locations
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University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Countries
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References
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Willi C, Bodenmann P, Ghali WA, Faris PD, Cornuz J. Active smoking and the risk of type 2 diabetes: a systematic review and meta-analysis. JAMA. 2007 Dec 12;298(22):2654-64. doi: 10.1001/jama.298.22.2654.
Doll R, Peto R, Boreham J, Sutherland I. Mortality in relation to smoking: 50 years' observations on male British doctors. BMJ. 2004 Jun 26;328(7455):1519. doi: 10.1136/bmj.38142.554479.AE. Epub 2004 Jun 22.
Stamler J, Vaccaro O, Neaton JD, Wentworth D. Diabetes, other risk factors, and 12-yr cardiovascular mortality for men screened in the Multiple Risk Factor Intervention Trial. Diabetes Care. 1993 Feb;16(2):434-44. doi: 10.2337/diacare.16.2.434.
Grimshaw JM, Eccles MP, Lavis JN, Hill SJ, Squires JE. Knowledge translation of research findings. Implement Sci. 2012 May 31;7:50. doi: 10.1186/1748-5908-7-50.
Reid RD, Pipe AL, Quinlan B. Promoting smoking cessation during hospitalization for coronary artery disease. Can J Cardiol. 2006 Jul;22(9):775-80. doi: 10.1016/s0828-282x(06)70294-x.
Reid RD, Pipe AL, Quinlan B, Oda J. Interactive voice response telephony to promote smoking cessation in patients with heart disease: a pilot study. Patient Educ Couns. 2007 Jun;66(3):319-26. doi: 10.1016/j.pec.2007.01.005. Epub 2007 Mar 1.
Reid RD, Mullen KA, Slovinec D'Angelo ME, Aitken DA, Papadakis S, Haley PM, McLaughlin CA, Pipe AL. Smoking cessation for hospitalized smokers: an evaluation of the "Ottawa Model". Nicotine Tob Res. 2010 Jan;12(1):11-8. doi: 10.1093/ntr/ntp165. Epub 2009 Nov 10.
Reid RD, Mullen KA, Pipe AL. Systematic approaches to smoking cessation in the cardiac setting. Curr Opin Cardiol. 2011 Sep;26(5):443-8. doi: 10.1097/HCO.0b013e3283497499.
SRNT Subcommittee on Biochemical Verification. Biochemical verification of tobacco use and cessation. Nicotine Tob Res. 2002 May;4(2):149-59. doi: 10.1080/14622200210123581. No abstract available.
Donner A, Donald A. Analysis of data arising from a stratified design with the cluster as unit of randomization. Stat Med. 1987 Jan-Feb;6(1):43-52. doi: 10.1002/sim.4780060106.
Thompson SG, Pyke SD, Hardy RJ. The design and analysis of paired cluster randomized trials: an application of meta-analysis techniques. Stat Med. 1997 Sep 30;16(18):2063-79. doi: 10.1002/(sici)1097-0258(19970930)16:183.0.co;2-8.
Campbell MK, Mollison J, Grimshaw JM. Cluster trials in implementation research: estimation of intracluster correlation coefficients and sample size. Stat Med. 2001 Feb 15;20(3):391-9. doi: 10.1002/1097-0258(20010215)20:33.0.co;2-z.
Papadakis S, Aitken D, Gocan S, Riley D, Laplante MA, Bhatnagar-Bost A, Cousineau D, Simpson D, Edjoc R, Pipe AL, Sharma M, Reid RD. A randomised controlled pilot study of standardised counselling and cost-free pharmacotherapy for smoking cessation among stroke and TIA patients. BMJ Open. 2011 Nov 28;1(2):e000366. doi: 10.1136/bmjopen-2011-000366. Print 2011.
Reid RD, Pipe A, Dafoe WA. Is telephone counselling a useful addition to physician advice and nicotine replacement therapy in helping patients to stop smoking? A randomized controlled trial. CMAJ. 1999 Jun 1;160(11):1577-81.
Reid RD, Pipe AL. A telephone-based support program for over-the-counter nicotine patch users. Can J Public Health. 1999 Nov-Dec;90(6):397-8. doi: 10.1007/BF03404144. No abstract available.
Slovinec D'Angelo ME, Reid RD, Hotz S, Irvine J, Segal RJ, Blanchard CM, Pipe A. Is stress management training a useful addition to physician advice and nicotine replacement therapy during smoking cessation in women? Results of a randomized trial. Am J Health Promot. 2005 Nov-Dec;20(2):127-34. doi: 10.4278/0890-1171-20.2.127.
Rigotti NA, Pipe AL, Benowitz NL, Arteaga C, Garza D, Tonstad S. Efficacy and safety of varenicline for smoking cessation in patients with cardiovascular disease: a randomized trial. Circulation. 2010 Jan 19;121(2):221-9. doi: 10.1161/CIRCULATIONAHA.109.869008. Epub 2010 Jan 4.
Campbell MK, Piaggio G, Elbourne DR, Altman DG; CONSORT Group. Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012 Sep 4;345:e5661. doi: 10.1136/bmj.e5661. No abstract available.
Reid RD, Malcolm J, Wooding E, Geertsma A, Aitken D, Arbeau D, Blanchard C, Gagnier JA, Gupta A, Mullen KA, Oh P, Papadakis S, Tulloch H, LeBlanc AG, Wells GA, Pipe AL. Prospective, Cluster-Randomized Trial to Implement the Ottawa Model for Smoking Cessation in Diabetes Education Programs in Ontario, Canada. Diabetes Care. 2018 Mar;41(3):406-412. doi: 10.2337/dc17-1809. Epub 2017 Dec 21.
Other Identifiers
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20130177-01H
Identifier Type: -
Identifier Source: org_study_id
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