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

April 19, 2022 updated by: Ottawa Heart Institute Research Corporation

A Prospective Cluster-Randomized Trial to Implement the Ottawa Model for Smoking Cessation in Diabetes Education Programs.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

313

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4W7
        • University of Ottawa Heart Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Wait-Listed Control Group
Usual care for smoking cessation
Experimental: Ottawa Model for Smoking Cessation
Behavioral: Ottawa Model for Smoking Cessation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who 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.
26 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost-effectiveness of Smoking Cessation Interventions.
Time Frame: 26 weeks
The cost to implement and maintain the smoking cessation intervention at the patient-level. Cost to implement for patients included program materials, education and counseling.
26 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implementation Costs - Clinic
Time Frame: 26 weeks
The cost to implement the smoking cessation intervention were calculated a the clinic level. This included all costs related to staff training and program materials.
26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

October 18, 2016

Study Completion (Actual)

March 15, 2017

Study Registration Dates

First Submitted

November 1, 2013

First Submitted That Met QC Criteria

November 1, 2013

First Posted (Estimate)

November 8, 2013

Study Record Updates

Last Update Posted (Actual)

April 20, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20130177-01H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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