Trial Outcomes & Findings for Evaluation of the Ottawa Model for Smoking Cessation in Diabetes Education Programs (NCT NCT01980017)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

313 participants

Primary outcome timeframe

26 weeks

Results posted on

2022-04-20

Participant Flow

Participant milestones

Participant milestones
Measure	Wait-Listed Control Group Usual care for smoking cessation	Ottawa Model for Smoking Cessation Ottawa Model for Smoking Cessation
Overall Study STARTED	114	199
Overall Study COMPLETED	84	177
Overall Study NOT COMPLETED	30	22

Reasons for withdrawal

Reasons for withdrawal
Measure	Wait-Listed Control Group Usual care for smoking cessation	Ottawa Model for Smoking Cessation Ottawa Model for Smoking Cessation
Overall Study Lost to Follow-up	30	21
Overall Study Death	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Wait-Listed Control Group n=114 Participants Usual care for smoking cessation	Ottawa Model for Smoking Cessation n=199 Participants Ottawa Model for Smoking Cessation	Total n=313 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	76 Participants n=5 Participants	136 Participants n=7 Participants	212 Participants n=5 Participants
Age, Categorical >=65 years	38 Participants n=5 Participants	63 Participants n=7 Participants	101 Participants n=5 Participants
Age, Continuous	54.9 years n=5 Participants	54 years n=7 Participants	54.4 years n=5 Participants
Sex: Female, Male Female	49 Participants n=5 Participants	89 Participants n=7 Participants	138 Participants n=5 Participants
Sex: Female, Male Male	65 Participants n=5 Participants	110 Participants n=7 Participants	175 Participants n=5 Participants
Region of Enrollment Canada	114 participants n=5 Participants	199 participants n=7 Participants	313 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Wait-Listed Control Group n=114 Participants Usual care for smoking cessation	Ottawa Model for Smoking Cessation n=198 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	3 Participants	22 Participants

SECONDARY outcome

Timeframe: 26 weeks

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

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.

Outcome measures

Outcome measures
Measure	Wait-Listed Control Group n=199 Participants Usual care for smoking cessation	Ottawa Model for Smoking Cessation n=111 Participants Ottawa Model for Smoking Cessation
Cost-effectiveness of Smoking Cessation Interventions.	262 Dollars (CAD)	49 Dollars (CAD)

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Population: The number of clinics included in the analysis

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.

Outcome measures

Outcome measures
Measure	Wait-Listed Control Group n=7 Diabetes Clinics Usual care for smoking cessation	Ottawa Model for Smoking Cessation Ottawa Model for Smoking Cessation
Implementation Costs - Clinic	1870 Dollars (CAD)	—

Adverse Events

Wait-Listed Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ottawa Model for Smoking Cessation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Robert Reid

University of Ottawa Heart Institute

Phone: 6136967393

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place