Evaluation of the Ottawa Model for Smoking Cessation in Diabetes Education Programs (OMSC-DEP)
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. Investigators are surveying smokers who attend this clinic before and after implementing the new program. 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 baseline rates of assistance with smoking cessation at each clinic. Within each pair, sites will be allocated randomly to either OMSC intervention or control groups. In total, 2,520 participants will enroll in the study at one of the eighteen DEPs selected within the Champlain, Toronto Central, or Mississauga-Hamilton Local Health Integration Network. From each participating DEP, a "before" and "after" sample of 70 smokers will be recruited to assess smoking cessation outcomes. Over a three-month period between the before and after samples, strategies to implement the OMSC will be carried out at the intervention sites. 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.
Diabetic Type II Mellitus
Behavioral: Ottawa Model for Smoking Cessation
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Prospective Cluster-randomized Trial to Implement the Ottawa Model for Smoking Cessation in Diabetes Education Programs.|
- Self report of not smoking (even a puff) in the last 7 days + CO <10ppm [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]The OMSC intervention will increase carbon monoxide (CO) validated 7-day point prevalence abstinence rates at 6-month follow-up by at least 7% among smokers with diabetes referred to DEPs compared to standard care.
- Cost-effectiveness of smoking cessation interventions. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]There is clear evidence regarding the cost-effectiveness of smoking cessation interventions, there is a lack of implementation knowledge to inform the design and delivery of these interventions into routine clinical practice. This study considers an intervention that optimizes the effective use of smoking cessation interventions in 'real life' clinical education settings.
|Study Start Date:||July 2013|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
No Intervention: Controlled Group
Usual care for smoking cessation
Experimental: Ottawa Model for Smoking Cessation
Ottawa Model for Smoking Cessation
|Behavioral: Ottawa Model for Smoking Cessation|
|Contact: Amy Geertsma, BSc.||firstname.lastname@example.org|
|Contact: Ashley Armstrong, BA||613-798-555 ext email@example.com|
|University of Ottawa Heart Institute||Recruiting|
|Ottawa, Ontario, Canada, K1Y 4W7|
|Contact: Amy Geertsma, BSc 613-761-4488 firstname.lastname@example.org|
|Contact: Ashley Armstrong, BA 613-798-5555 ext 19345 email@example.com|
|Principal Investigator:||Robert Reid, PhD., MBA||University of Ottawa Heart Institute|
|Study Chair:||Andrew Pipe, MD, FRCPC||University of Ottawa Heart Institute|
|Study Chair:||Oh Paul, MD, FRCPC||Toronto Rehabilitation Institute|
|Study Chair:||Anil Gupta, MD, FRCPC||Trillium Heath Centre|
|Study Chair:||Kocourek Jana, MA||University of Ottawa Heart Institute|
|Study Chair:||Mullen Kerri-Anne, MSc.||University of Ottawa Heart Institute|
|Study Chair:||Aiken Debbie, BScN||University of Ottawa Heart Institute|
|Study Chair:||Tulloch Heather, Ph.D., Psych.||University of Ottawa Heart Institute|
|Study Chair:||David Arbeau, BA, BTech, RT||Horizon Health Network|
|Study Chair:||Malcolm Janine, MD, FRCPC||Faculty of Medicine, University of Ottawa|