Clinical trial NCT01980017: Evaluation of the Ottawa Model for Smoking Cessation in Diabetes Education Programs
Official title: A Prospective Cluster-Randomized Trial to Implement the Ottawa Model for Smoking Cessation in Diabetes Education Programs.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-diabetic
Diabetic Type II Mellitus
Keywords: Diabetes Type 2 Mellitus
Ottawa Model for Smoking Cessation
Diabetes Education Programs
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2013-11-08
Enrollment: 313
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Percentage of Participants Who Self Report of Not Smoking (Even a Puff) in the Last 7 Days + CO <10ppm
timeFrame: 26 weeks
Secondary outcomes:
measure: Cost-effectiveness of Smoking Cessation Interventions.
timeFrame: 26 weeks
Other outcomes:
measure: Implementation Costs - Clinic
timeFrame: 26 weeks
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Robert Reid, PhD., MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: Ottawa Heart Institute Research Corporation
name: Andrew Pipe, MD, FRCPC
role: STUDY_CHAIR
affiliation: Toronto Rehabilitation Institute
name: Oh Paul, MD, FRCPC
role: STUDY_CHAIR
affiliation: Trillium Heath Centre
name: Anil Gupta, MD, FRCPC
role: STUDY_CHAIR
affiliation: Ottawa Heart Institute Research Corporation
name: Kocourek Jana, MA
role: STUDY_CHAIR
affiliation: Ottawa Heart Institute Research Corporation
name: Mullen Kerri-Anne, MSc.
role: STUDY_CHAIR
affiliation: Ottawa Heart Institute Research Corporation
name: Aiken Debbie, BScN
role: STUDY_CHAIR
affiliation: Ottawa Heart Institute Research Corporation
name: Tulloch Heather, Ph.D., Psych.
role: STUDY_CHAIR
affiliation: Horizon Health Network
name: David Arbeau, BA, BTech, RT
role: STUDY_CHAIR
affiliation: Faculty of Medicine, University of Ottawa
name: Malcolm Janine, MD, FRCPC
role: STUDY_CHAIR
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