Diabetic Type II Mellitus, Pre-diabetic
Conditions
Keywords
Diabetes Type 2 Mellitus, Ottawa Model for Smoking Cessation, Diabetes Education Programs
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.
Interventions
BEHAVIORALOttawa Model for Smoking Cessation
Sponsors
Ottawa Heart Institute Research Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Wait-Listed Control Group Usual care for smoking cessation | 114 |
| Ottawa Model for Smoking Cessation Ottawa Model for Smoking Cessation | 199 |
| Total | 313 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Lost to Follow-up | 30 | 21 |
Baseline characteristics
| Characteristic | Ottawa Model for Smoking Cessation | Wait-Listed Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 63 Participants | 38 Participants | 101 Participants |
| Age, Categorical Between 18 and 65 years | 136 Participants | 76 Participants | 212 Participants |
| Age, Continuous | 54 years | 54.9 years | 54.4 years |
| Region of Enrollment Canada | 199 participants | 114 participants | 313 participants |
| Sex: Female, Male Female | 89 Participants | 49 Participants | 138 Participants |
| Sex: Female, Male Male | 110 Participants | 65 Participants | 175 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 114 | 0 / 199 |
| other Total, other adverse events | 0 / 114 | 0 / 199 |
| serious Total, serious adverse events | 0 / 114 | 0 / 199 |
Outcome results
Primary
Percentage of Participants Who Self Report of Not Smoking (Even a Puff) in the Last 7 Days + CO <10ppm
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
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Wait-Listed Control Group | Percentage of Participants Who Self Report of Not Smoking (Even a Puff) in the Last 7 Days + CO <10ppm | 3 Participants |
| Ottawa Model for Smoking Cessation | Percentage of Participants Who Self Report of Not Smoking (Even a Puff) in the Last 7 Days + CO <10ppm | 22 Participants |
Secondary
Cost-effectiveness of Smoking Cessation Interventions.
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
Population: The per patient cost was calculated along with the per patient cost for those who did not want to quit smoking.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Wait-Listed Control Group | Cost-effectiveness of Smoking Cessation Interventions. | 262 Dollars (CAD) |
| Ottawa Model for Smoking Cessation | Cost-effectiveness of Smoking Cessation Interventions. | 49 Dollars (CAD) |
Other Pre-specified
Implementation Costs - Clinic
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
Population: The number of clinics included in the analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Wait-Listed Control Group | Implementation Costs - Clinic | 1870 Dollars (CAD) |