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

• Sponsor: Ottawa Heart Institute Research Corporation (Other)
• Overall Status: Completed
• CT.gov ID: NCT01980017
• Collaborator: (none)
• Enrollment: 313
• Location: 1
• Arms: 2
• Duration (Months): 44.5
• Patients Per Site Per Month: 7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pre-diabetic; Diabetic Type II Mellitus	Behavioral: Ottawa Model for Smoking Cessation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 313 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Prospective Cluster-Randomized Trial to Implement the Ottawa Model for Smoking Cessation in Diabetes Education Programs.
• Study Start Date: Jul 1, 2013
• Actual Primary Completion Date: Oct 18, 2016
• Actual Study Completion Date: Mar 15, 2017

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Who Self Report of Not Smoking (Even a Puff) in the Last 7 Days + CO <10ppm [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.

Secondary Outcome Measures

1. Cost-effectiveness of Smoking Cessation Interventions. [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.

Other Outcome Measures

1. Implementation Costs - Clinic [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University of Ottawa Heart Institute	Ottawa	Ontario	Canada	K1Y 4W7

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• Campbell MK, Mollison J, Grimshaw JM. Cluster trials in implementation research: estimation of intracluster correlation coefficients and sample size. Stat Med. 2001 Feb 15;20(3):391-9.
• Campbell MK, Piaggio G, Elbourne DR, Altman DG; CONSORT Group. Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012 Sep 4;345:e5661. doi: 10.1136/bmj.e5661.
• Doll R, Peto R, Boreham J, Sutherland I. Mortality in relation to smoking: 50 years' observations on male British doctors. BMJ. 2004 Jun 26;328(7455):1519. Epub 2004 Jun 22.
• Donner A, Donald A. Analysis of data arising from a stratified design with the cluster as unit of randomization. Stat Med. 1987 Jan-Feb;6(1):43-52.
• Grimshaw JM, Eccles MP, Lavis JN, Hill SJ, Squires JE. Knowledge translation of research findings. Implement Sci. 2012 May 31;7:50. doi: 10.1186/1748-5908-7-50.
• Papadakis S, Aitken D, Gocan S, Riley D, Laplante MA, Bhatnagar-Bost A, Cousineau D, Simpson D, Edjoc R, Pipe AL, Sharma M, Reid RD. A randomised controlled pilot study of standardised counselling and cost-free pharmacotherapy for smoking cessation among stroke and TIA patients. BMJ Open. 2011 Nov 28;1(2):e000366. doi: 10.1136/bmjopen-2011-000366. Print 2011.
• Reid RD, Mullen KA, Pipe AL. Systematic approaches to smoking cessation in the cardiac setting. Curr Opin Cardiol. 2011 Sep;26(5):443-8. doi: 10.1097/HCO.0b013e3283497499. Review.
• Reid RD, Mullen KA, Slovinec D'Angelo ME, Aitken DA, Papadakis S, Haley PM, McLaughlin CA, Pipe AL. Smoking cessation for hospitalized smokers: an evaluation of the "Ottawa Model". Nicotine Tob Res. 2010 Jan;12(1):11-8. doi: 10.1093/ntr/ntp165. Epub 2009 Nov 10.
• Reid RD, Pipe A, Dafoe WA. Is telephone counselling a useful addition to physician advice and nicotine replacement therapy in helping patients to stop smoking? A randomized controlled trial. CMAJ. 1999 Jun 1;160(11):1577-81.
• Reid RD, Pipe AL, Quinlan B, Oda J. Interactive voice response telephony to promote smoking cessation in patients with heart disease: a pilot study. Patient Educ Couns. 2007 Jun;66(3):319-26. Epub 2007 Mar 1.
• Reid RD, Pipe AL, Quinlan B. Promoting smoking cessation during hospitalization for coronary artery disease. Can J Cardiol. 2006 Jul;22(9):775-80.
• Reid RD, Pipe AL. A telephone-based support program for over-the-counter nicotine patch users. Can J Public Health. 1999 Nov-Dec;90(6):397-8.
• Rigotti NA, Pipe AL, Benowitz NL, Arteaga C, Garza D, Tonstad S. Efficacy and safety of varenicline for smoking cessation in patients with cardiovascular disease: a randomized trial. Circulation. 2010 Jan 19;121(2):221-9. doi: 10.1161/CIRCULATIONAHA.109.869008. Epub 2010 Jan 4.
• Slovinec D'Angelo ME, Reid RD, Hotz S, Irvine J, Segal RJ, Blanchard CM, Pipe A. Is stress management training a useful addition to physician advice and nicotine replacement therapy during smoking cessation in women? Results of a randomized trial. Am J Health Promot. 2005 Nov-Dec;20(2):127-34.
• SRNT Subcommittee on Biochemical Verification. Biochemical verification of tobacco use and cessation. Nicotine Tob Res. 2002 May;4(2):149-59.
• Stamler J, Vaccaro O, Neaton JD, Wentworth D. Diabetes, other risk factors, and 12-yr cardiovascular mortality for men screened in the Multiple Risk Factor Intervention Trial. Diabetes Care. 1993 Feb;16(2):434-44.
• Thompson SG, Pyke SD, Hardy RJ. The design and analysis of paired cluster randomized trials: an application of meta-analysis techniques. Stat Med. 1997 Sep 30;16(18):2063-79.
• Willi C, Bodenmann P, Ghali WA, Faris PD, Cornuz J. Active smoking and the risk of type 2 diabetes: a systematic review and meta-analysis. JAMA. 2007 Dec 12;298(22):2654-64. Review.

• Responsible Party: Ottawa Heart Institute Research Corporation
• ClinicalTrials.gov Identifier: NCT01980017
• Other Study ID Numbers: 20130177-01H
• First Posted: Nov 8, 2013
• Last Update Posted: Apr 20, 2022
• Last Verified: Apr 1, 2022

• 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

Study Results

Participant Flow

Arm/Group Title	Wait-Listed Control Group	Ottawa Model for Smoking Cessation
Arm/Group Description	Usual care for smoking cessation	Ottawa Model for Smoking Cessation
Period Title: Overall Study
STARTED	114	199
COMPLETED	84	177
NOT COMPLETED	30	22

Baseline Characteristics

Arm/Group Title	Wait-Listed Control Group	Ottawa Model for Smoking Cessation	Total
Arm/Group Description	Usual care for smoking cessation	Ottawa Model for Smoking Cessation	Total of all reporting groups
Overall Participants	114	199	313
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	76 66.7%	136 68.3%	212 67.7%
>=65 years	38 33.3%	63 31.7%	101 32.3%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	54.9	54	54.4
Sex: Female, Male (Count of Participants)
Female	49 43%	89 44.7%	138 44.1%
Male	65 57%	110 55.3%	175 55.9%
Region of Enrollment (participants) [Number]
Canada	114 100%	199 100%	313 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Who Self Report of Not Smoking (Even a Puff) in the Last 7 Days + CO <10ppm
Description	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.
Time Frame	26 weeks

Outcome Measure Data

Analysis Population Description

One participant from the Intervention (Ottawa Model for Smoking Cessation group) was not included in the analysis as they died during the intervention phase.

Arm/Group Title	Wait-Listed Control Group	Ottawa Model for Smoking Cessation
Arm/Group Description	Usual care for smoking cessation	Ottawa Model for Smoking Cessation
Measure Participants	114	198
Count of Participants [Participants]	3 2.6%	22 11.1%

2. Secondary Outcome

Title	Cost-effectiveness of Smoking Cessation Interventions.
Description	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.
Time Frame	26 weeks

Outcome Measure Data

Analysis Population Description

The per patient cost was calculated along with the per patient cost for those who did not want to quit smoking.

Arm/Group Title	Implementation Cost - Patient	Implementation Cost - Patient Not Ready to Quit
Arm/Group Description	Per-patient cost to implement program	Per-patient cost for those who are not ready to quit smoking
Measure Participants	199	111
Number [Dollars (CAD)]	262	49

3. Other Pre-specified Outcome

Title	Implementation Costs - Clinic
Description	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.
Time Frame	26 weeks

Outcome Measure Data

Analysis Population Description

The number of clinics included in the analysis

Arm/Group Title	Implementation Costs - Clinic
Arm/Group Description	The cost to implement and maintain the smoking cessation intervention at the clinic level.
Measure Participants	NA
Measure Diabetes Clinics	7
Number [Dollars (CAD)]	1870

Adverse Events

Time Frame	Adverse event data was collected from baseline to 6 months.
Adverse Event Reporting Description	This was a low risk study. Diabetes clinics were asked to implement a smoking cessation program and offer the related services to their patients. This study assessed the implementation of the program (how successful clinics were in implementing the program and actually getting patients to quit smoking).
Arm/Group Title	Wait-Listed Control Group		Ottawa Model for Smoking Cessation
Arm/Group Description	Usual care for smoking cessation		Ottawa Model for Smoking Cessation
All Cause Mortality
	Wait-Listed Control Group		Ottawa Model for Smoking Cessation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/114 (0%)		0/199 (0%)
Serious Adverse Events
	Wait-Listed Control Group		Ottawa Model for Smoking Cessation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/114 (0%)		0/199 (0%)
Other (Not Including Serious) Adverse Events
	Wait-Listed Control Group		Ottawa Model for Smoking Cessation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/114 (0%)		0/199 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.