A PROSPECTIVE CLUSTER-RANDOMIZED TRIAL TO IMPLEMENT THE OTTAWA MODEL FOR SMOKING CESSATION IN DIABETES EDUCATION PROGRAMS IN CANADA

Abstract

Smoking cessation is essential to reduce the risk of morbidity and mortality in smokers with diabetes or pre-diabetes. Diabetes education programs could provide smoking cessation interventions but evidence of their successful implementation in such settings is lacking. The Ottawa Model for Smoking Cessation (OMSC) is a proven, practice-level intervention designed to promote the systematic identification, treatment and follow-up of smokers. The objective of this study was to examine the effect of implementing the OMSC in diabetes education programs as measured by long-term abstinence rates among smoker-patients. This was a matched-pair cluster-randomized trial conducted in 15 diabetes education programs in Ontario, Canada. Diabetes education programs were matched based on the number of referrals for diabetes education each year (≤500 or >500). Within each pair, sites were randomly allocated to either the OMSC intervention (n=7), or a wait-list control condition (n=8). Intervention: Diabetes education programs in the intervention group introduced standardized processes to identify and provide smoking cessation interventions and follow-up. Diabetes education staff received training in the use of smoking cessation medications and behavioural counselling techniques to assist smokers with quitting. Smokers in the intervention group received counselling from their diabetes educator, a prescription for smoking cessation medication, a discount card to partly cover the cost of smoking cessation medication, automated telephone follow-up calls, and nurse counselling over a six-month intervention period. Smokers in the control condition received usual care for smoking cessation from their diabetes education program. Diabetes education programs in the wait-list control condition were offered the OMSC intervention after a 1-year waiting period. The primary end point was carbon monoxide (CO)-confirmed abstinence from smoking at 6-month follow-up. We recruited 313 smokers including (n=199 intervention group and n=114 control group) with diabetes and pre-diabetes between November 2013 and October 2016. The mean age of participants was 54.4 [SD 10.6] years, 56% were male, and mean cigarettes smoked per day was 19.3 [SD 11.1]. The CO-confirmed abstinence rate was 11.0% among intervention participants compared to 3.5% among control participants (OR=3.17; 95% CI: 1.13, 8.93, p=0.03). Implementation of the OMSC in diabetes education programs resulted in clinically and statistically significant improvements in long-term abstinence among smokers with diabetes or pre-diabetes. Abstinence rates in both groups were low compared to those reported among smokers with other clinical conditions. Clinical Trial Registration No.: NCT01980017.