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

Nadia Minian, Mathangee Lingam, Rahim Moineddin, Kevin E Thorpe, Scott Veldhuizen, Rosa Dragonetti, Laurie Zawertailo, Valerie H Taylor, Margaret Hahn, Wayne K deRuiter, Osnat Melamed, Peter Selby, Nadia Minian, Mathangee Lingam, Rahim Moineddin, Kevin E Thorpe, Scott Veldhuizen, Rosa Dragonetti, Laurie Zawertailo, Valerie H Taylor, Margaret Hahn, Wayne K deRuiter, Osnat Melamed, Peter Selby

Abstract

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://ichgcp.net/clinical-trials-registry/NCT04223336.

International registered report identifier (irrid): DERR1-10.2196/19157.

Keywords: clinical decision support system; healthy eating; hybrid type 1; physical activity; smoking cessation.

Conflict of interest statement

Conflicts of Interest: The authors declare that they have no conflicts of interests with respect to this manuscript; however, some authors have general disclosures to report. PS reports receiving grants and/or salary from Centre for Addiction and Mental Health, Ontario Ministry of Health and Long-Term Care, CIHR, Canadian Centre on Substance Use and Addiction, Public Health Agency of Canada, Medical Psychiatry Alliance, Canadian Cancer Society Research Institute, Cancer Care Ontario, and the Ontario Institute for Cancer Research. PS also reports receiving funding from the following commercial organizations: Pfizer Inc/Pfizer Canada, Bhasin Consulting Fund, Shoppers Drug Mart, and Patient-Centered Outcomes Research Institute. PS has received consulting fees from Pfizer Inc/Pfizer Canada, Johnson & Johnson Group of Companies, and MedPlan Communications. Through an open tender process, Johnson & Johnson, Novartis, and Pfizer Inc are vendors of record for providing smoking cessation pharmacotherapy, free or discounted, for research studies in which PS is the principal investigator or coinvestigator. MH reports receiving consulting fees from Alkermes. WD reports grant funding from Pfizer Inc, Abbott Laboratories, and Medical Psychiatry Alliance. WD also reports stock ownership in Abbott Laboratories.

©Nadia Minian, Mathangee Lingam, Rahim Moineddin, Kevin E Thorpe, Scott Veldhuizen, Rosa Dragonetti, Laurie Zawertailo, Valerie H Taylor, Margaret Hahn, Wayne K DeRuiter, Osnat Melamed, Peter Selby. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 29.09.2020.

Figures

Figure 1
Figure 1
Study workflow diagram. FV: fruits and vegetables.

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