Evaluation of the Ottawa Model for Smoking Cessation in Diabetes Education Programs

NCT01980017 | Completed Results

• 1 other identifier: 20130177-01H
• Study Type: interventional
• Target: 313
• Locations: 1 country
• Sites: 1

Brief Summary

The incidence of type 2 diabetes mellitus (T2DM) is increasing rapidly. The combination of T2DM and smoking is particularly lethal, as smokers with T2DM are significantly more likely to develop a number of health related complications. Community-based diabetes education programs (DEPs) have been developed to support patient self-care behaviours (e.g. adherence to oral medications, insulin therapy, nutrition management, regular blood glucose monitoring, and physical activity); however, specific assistance for smoking cessation is rarely provided. Our investigative team has developed a knowledge transfer and practice change process to introduce evidence-based interventions for smoking cessation into clinical practice settings. This process is known as the Ottawa Model for Smoking Cessation (OMSC). Investigators believe there is an opportunity to use the OMSC intervention to dramatically enhance the effectiveness of DEPs in addressing smoking cessation among smokers with T2DM, and in so doing, improve quit rates in this high risk population. 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.

Conditions

Pre-diabetic; Diabetic Type II Mellitus

Keywords

Diabetes Type 2 Mellitus; Ottawa Model for Smoking Cessation; Diabetes Education Programs

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Self Report of Not Smoking (Even a Puff) in the Last 7 Days + CO <10ppm

  The OMSC intervention will increase carbon monoxide (CO) validated 7-day point prevalence abstinence rates at 6-month follow-up by at least 10% among smokers with diabetes referred to DEPs compared to standard care.

  26 weeks

Secondary Outcomes (1)

• Cost-effectiveness of Smoking Cessation Interventions.

  26 weeks

Other Outcomes (1)

• Implementation Costs - Clinic

  26 weeks

Study Arms (2)

Wait-Listed Control Group

NO INTERVENTION

Usual care for smoking cessation

Ottawa Model for Smoking Cessation

EXPERIMENTAL

Ottawa Model for Smoking Cessation

Behavioral: Ottawa Model for Smoking Cessation

Interventions

Ottawa Model for Smoking Cessation BEHAVIORAL

Ottawa Model for Smoking Cessation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient has been referred to DEP for T2DM diabetes or pre-diabetes.
• 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.

You may not qualify if:

• The patient is currently involved in any other smoking cessation intervention.
• The patient is able to read and understand French or English.
• The patient is able to and willing to provide informed consent.

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Related Publications (19)

• 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.

  PMID: 18073361 BACKGROUND

• 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.

  PMID: 15213107 BACKGROUND

• 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.

  PMID: 8432214 BACKGROUND

• 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.

  PMID: 22651257 BACKGROUND

• 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.

  PMID: 16835672 BACKGROUND

• 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.

  PMID: 17336026 BACKGROUND

• 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.

  PMID: 19903737 BACKGROUND

• 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.

  PMID: 21730824 BACKGROUND

• 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.

  PMID: 12028847 BACKGROUND

• 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.

  PMID: 3576016 BACKGROUND

• 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.

  PMID: 9308132 BACKGROUND

• 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.

  PMID: 11180309 BACKGROUND

• 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.

  PMID: 22123923 BACKGROUND

• 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.

  PMID: 10373999 BACKGROUND

• 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.

  PMID: 10680265 BACKGROUND

• 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.

  PMID: 16295704 BACKGROUND

• 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.

  PMID: 20048210 BACKGROUND

• 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.

  PMID: 22951546 BACKGROUND

• 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.

  PMID: 29269509 DERIVED

MeSH Terms

Conditions

Glucose Intolerance; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Robert Reid
• Organization: University of Ottawa Heart Institute

breid@ottawaheart.ca

6136967393

Study Officials

• Robert Reid, PhD., MBA

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

• Andrew Pipe, MD, FRCPC

  Ottawa Heart Institute Research Corporation

  STUDY CHAIR

• Oh Paul, MD, FRCPC

  Toronto Rehabilitation Institute

  STUDY CHAIR

• Anil Gupta, MD, FRCPC

  Trillium Heath Centre

  STUDY CHAIR

• Kocourek Jana, MA

  Ottawa Heart Institute Research Corporation

  STUDY CHAIR

• Mullen Kerri-Anne, MSc.

  Ottawa Heart Institute Research Corporation

  STUDY CHAIR

• Aiken Debbie, BScN

  Ottawa Heart Institute Research Corporation

  STUDY CHAIR

• Tulloch Heather, Ph.D., Psych.

  Ottawa Heart Institute Research Corporation

  STUDY CHAIR

• David Arbeau, BA, BTech, RT

  Horizon Health Network

  STUDY CHAIR

• Malcolm Janine, MD, FRCPC

  Faculty of Medicine, University of Ottawa

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2013
• First Posted: November 8, 2013
• Study Start: July 1, 2013
• Primary Completion: October 18, 2016
• Study Completion: March 15, 2017
• Last Updated: April 20, 2022
• Results First Posted: April 20, 2022

Record last verified: 2022-04

Locations

CA (1)