Evaluation of the Ottawa Model for Smoking Cessation in Diabetes Education Programs (OMSC in DEP)
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|ClinicalTrials.gov Identifier: NCT01980017|
Recruitment Status : Completed
First Posted : November 8, 2013
Last Update Posted : December 11, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Pre-diabetic Diabetic Type II Mellitus||Behavioral: Ottawa Model for Smoking Cessation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||313 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Cluster-Randomized Trial to Implement the Ottawa Model for Smoking Cessation in Diabetes Education Programs.|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||October 18, 2016|
|Actual Study Completion Date :||March 15, 2017|
No Intervention: Wait-Listed Control Group
Usual care for smoking cessation
Experimental: Ottawa Model for Smoking Cessation
Ottawa Model for Smoking Cessation
|Behavioral: Ottawa Model for Smoking Cessation|
- Self report of not smoking (even a puff) in the last 7 days + CO <10ppm [ Time Frame: 26 weeks ]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.
- Cost-effectiveness of smoking cessation interventions. [ Time Frame: 26 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01980017
|University of Ottawa Heart Institute|
|Ottawa, Ontario, Canada, K1Y 4W7|
|Principal Investigator:||Robert Reid, PhD., MBA||Ottawa Heart Institute Research Corporation|
|Study Chair:||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|