Impact of a Web-Based Clinical Decision Support System to Assist Practitioners in Addressing Physical Activity and/or Healthy Eating for Smoking Cessation Treatment: Protocol for a Hybrid Type I Randomized Controlled Trial

Background Modifiable risk factors such as tobacco use, physical inactivity, and poor diet account for a significant proportion of the preventable deaths in Canada. These factors are also known to cluster together, thereby compounding the risks of morbidity and mortality. Given this association, smoking cessation programs appear to be well-suited for integration of health promotion activities for other modifiable risk factors. The Smoking Treatment for Ontario Patients (STOP) program is a province-wide smoking cessation program that currently encourages practitioners to deliver Screening, Brief Intervention, and Referral to treatment for patients who are experiencing depressive symptoms or consume excessive amounts of alcohol via a web-enabled clinical decision support system. However, there is no available clinical decision support system for physical inactivity and poor diet, which are among the leading modifiable risk factors for chronic diseases. Objective The aim of this study is to assess whether adding a computerized/web-enabled clinical decision support system for physical activity and diet to a smoking cessation program affects smoking cessation outcomes. Methods This study is designed as a hybrid type 1 effectiveness/implementation randomized controlled trial to evaluate a web-enabled clinical decision support system for supporting practitioners in addressing patients’ physical activity and diet as part of smoking cessation treatment in a primary care setting. This design was chosen as it allows for simultaneous testing of the intervention, its delivery in target settings, and the potential for implementation in real-world situations. Intervention effectiveness will be measured using a two-arm randomized controlled trial. Health care practitioners will be unblinded to their patients’ treatment allocation; however, patients will be blinded to whether their practitioner receives the clinical decision support system for physical activity and/or fruit/vegetable consumption. The evaluation of implementation will be guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Results Recruitment for the primary outcome of this study is ongoing and will be completed in November 2020. Results will be reported in March 2021. Conclusions The findings of the study will provide much needed insight into whether adding a computerized/web-enabled clinical decision support system for physical activity and diet to a smoking cessation program affects smoking cessation outcome. Furthermore, the implementation evaluation would provide insight into the feasibility of online-based interventions for physical activity and diet in a smoking cessation program. Addressing these risk factors simultaneously could have significant positive effects on chronic disease and cancer prevention. Trial Registration ClinicalTrials.gov NCT04223336; https://clinicaltrials.gov/ct2/show/NCT04223336 International Registered Report Identifier (IRRID) DERR1-10.2196/19157