Evaluation of the Ottawa Model for Smoking Cessation in Diabetes Education Programs
Condition: Pre-diabetic; Diabetic Type II Mellitus
MeSH terms: Prediabetic State
Study type: Interventional

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.
    


Intervention name(s): Ottawa Model for Smoking Cessation
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diabetes Type 2 Mellitus; Ottawa Model for Smoking Cessation; Diabetes Education Programs