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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Ottawa Heart Institute Research Corporation
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: June 18, 2014
Last verified: June 2014
  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. 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 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 Ottawa Heart Institute Research Corporation:

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 10% 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: 890
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: 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

  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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, MA 613-798-5555 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, MA    613-798-5555 ext 19345    aarmstrong@ottawaheart.ca   
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Investigators
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
  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: June 18, 2014
Health Authority: Canada: The Ottawa Health Science Network Research Ethics Board

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

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

ClinicalTrials.gov processed this record on October 19, 2014