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

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

Interventions

BEHAVIORAL

Ottawa Model for Smoking Cessation

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation

  lead OTHER

Principal Investigators

• Robert Reid, PhD., MBA · Ottawa Heart Institute Research Corporation

• Andrew Pipe, MD, FRCPC · Ottawa Heart Institute Research Corporation

• Oh Paul, MD, FRCPC · Toronto Rehabilitation Institute

• Anil Gupta, MD, FRCPC · Trillium Heath Centre

• Kocourek Jana, MA · Ottawa Heart Institute Research Corporation

• Mullen Kerri-Anne, MSc. · Ottawa Heart Institute Research Corporation

• Aiken Debbie, BScN · Ottawa Heart Institute Research Corporation

• Tulloch Heather, Ph.D., Psych. · Ottawa Heart Institute Research Corporation

• David Arbeau, BA, BTech, RT · Horizon Health Network

• Malcolm Janine, MD, FRCPC · Faculty of Medicine, University of Ottawa

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-07-31

Primary Completion

2016-10-18

Completion

2017-03-15

Countries

• Canada

Study Locations