Evaluation of the Ottawa Model for Smoking Cessation in Diabetes Education Programs (OMSC-DEP)

This study is currently recruiting participants.
Verified November 2013 by University of Ottawa Heart Institute
Sponsor:
Information provided by (Responsible Party):
Dr Robert Reid, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier:
NCT01980017
First received: November 1, 2013
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Pre-diabetic
Diabetic Type II Mellitus
Behavioral: Ottawa Model for Smoking Cessation

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by University of Ottawa Heart Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 2520
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)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient has been referred to DEP for 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01980017

Contacts
Contact: Amy Geertsma, BSc. 613-761-4488 ageertsma@ottawaheart.ca
Contact: Ashley Armstrong, BA 613-798-555 ext 19345 aarmstrong@ottawaheart.ca

Locations
Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Contact: Amy Geertsma, BSc    613-761-4488    ageertsma@ottawaheart.ca   
Contact: Ashley Armstrong, BA    613-798-5555 ext 19345    aarmstrong@ottawaheart.ca   
Sponsors and Collaborators
University of Ottawa Heart Institute
Investigators
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
  More Information

Publications:

Responsible Party: Dr Robert Reid, Robert D. Reid, PhD, MBA, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier: NCT01980017     History of Changes
Other Study ID Numbers: 20130177-01H
Study First Received: November 1, 2013
Last Updated: November 26, 2013
Health Authority: Canada: The Ottawa Health Science Network Research Ethics Board

Keywords provided by University of Ottawa Heart Institute:
Diabetes Type 2 Mellitus
Ottawa Model for Smoking Cessation
Diabetes Education Programs

Additional relevant MeSH terms:
Smoking
Prediabetic State
Habits
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 22, 2014