Personalized Smoking Cessation Infographic in COPD

Study Overview
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Brief Summary
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This study assesses the effect of a personalized smoking cessation infographic on physician smoking cessation counseling rates and smoking cessation pharmacotherapy prescription rates. The study assesses the difference in physician behaviour using an interrupted time series analysis (one-year pre vs. one-year post-intervention). General practitioners, nurse practitioners and respirologists who refer eligible patients (COPD, active smoking) for spirometry at the St. Michael's Hospital Pulmonary Function Lab will receive the infographic. This is a quality improvement initiative. The smoking cessation infographic uses individualized patient data (height, weight, sex, baseline FEV1, etc.) to produce a personalized lung function decline prediction over the next 15 years.

Detailed Description
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Chronic obstructive pulmonary disease (COPD) affects 11.8% of adult Ontarians, remains the leading cause of hospitalization in Canada, and cost the Canadian economy $770 million in 2010. Smoking cessation reduces mortality and improves quality of life in COPD, and also reduces the risk of developing stroke, coronary heart disease, and several types of cancer. Despite this evidence, 45% of patients with COPD continue to smoke. Previous trials have demonstrated that even brief smoking cessation advice offered by a physician can increase quit rates, with intensive interventions proving additionally effective. Despite this, only 37% of US and 54% of Canadian smokers who had a visit with a physician during the prior year had been advised to quit smoking. Barriers and enablers underlying this care gap are multi-fold. At the patient level, barriers to quitting include accessibility of appropriate therapy, low expectations of quit success (self-efficacy) and low expectations of risk mitigation by quitting (outcome expectancy). Enablers include easily available therapy, knowledge of ongoing smoking effects, and motivation to quit for personal gain. For clinicians, barriers to providing smoking cessation advice include perceived lack of cessation counseling skills (self-efficacy), lack of time, memory (forgetting to do it), and concerns about harming the doctor-patient relationship. Enablers include reminders to provide cessation advice and improved outcome expectancy (a belief that their patients have a reasonable chance of quitting). Among different lung function metrics, forced expiratory volume in one second (FEV1) is the best validated metric for quantifying the degree of lung function impairment and is used to define disease severity. Our group previously developed and validated a prediction tool that uses individual patient characteristics to predict a personalized rate of future FEV1 decline. Considering the barriers and enablers to effective smoking cessation interventions noted above, our team then designed a smoking cessation intervention centered on this lung function decline calculator. Given that smoking is a modifiable variable that affects the rate of lung function decline, we translated the original calculator into a clinical infographic which quantitatively demonstrates the consequences of quitting versus continuing smoking on lung function and its correlated patient-relevant outcomes, for each individual patient (i.e. a personalized biomedical risk assessment). This approach was informed by previous studies demonstrating the promise of biomedical risk assessment (the process of giving smokers feedback on the physical effects of smoking using physiological measurements) and tailored educational materials for smoking cessation. Such tools can enhance smoking cessation consultations, particularly when educational material is in a visual format. We first designed a prototype tool according to best infographic design and content evidence and then conducted a series of iterative 2-hour moderated focus groups with 4-5 COPD patient participants per group and semi-structured 1-on-1 interviews with respirologists, until saturation of themes [4 focus groups (20 participants), 4 interviews]. In a rapid cycle design process, we made changes to tool content and format after each focus group and interview, based on qualitative analysis of feedback. This infographic is designed for clinicians to use as a facilitator for smoking cessation intervention delivery with their patients. It demonstrates expected FEV1 decline with and without smoking cessation, and corresponding patient-relevant morbidities (page 1), and provides clinicians with guidance for smoking cessation pharmacotherapy prescriptions (page 2). With this project, we seek to evaluate this tool in real-world practice to determine implementation feasibility and preliminary impact. The tool will not only act as a prompt for clinicians to provide smoking cessation counseling, but also serves to improve their self-efficacy and to enhance outcome expectancy with respect to smoking cessation advice. In turn, it provides patients with a personalized analysis of the future impact of their smoking and the benefit of a quit, with a goal of enhancing motivation to quit.

Official Title
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Personalized Biomedical Risk Assessment for Smoking Cessation in Chronic Obstructive Pulmonary Disease

Conditions
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Chronic Obstructive Pulmonary Disease (COPD), Smoking Cessation

Intervention / Treatment
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* Behavioral: Smoking Cessation Intervention Tool


Participation Criteria
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Eligibility Criteria
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Eligible clinicians will include respirologists, general practitioners and nurse practitioners who refer patients for spirometry testing at the St. Michael's Hospital Pulmonary Function Lab.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control - None<br>A retrospective chart review will assess physician/NP behaviour (rates of smoking cessation counselling and prescription of smoking cessation pharmacotherapy) in the one-year pre-intervention period. | |
| Intervention - Smoking cessation infographic<br>Throughout the intervention period, the personalized smoking cessation infographic will be provided to physicians/NPs (for eligible patients). Chart review will be conducted for the patient's physician/NP within a three-month window of receiving the infographic to assess outcomes. | Behavioral: Smoking Cessation Intervention Tool<br>* A personalized smoking cessation infographic is provided to the physician/NP alongside the patient's regular spirometry report.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of eligible, smoking patients with COPD who receive a smoking cessation counselling intervention | Using prospective chart review, we will assess the proportion of smoking patients with COPD who receive or are referred to a smoking cessation intervention at or after the index visit, in each analysis period | 12 months, broken into individual time series periods | 
| Proportions of eligible, smoking patients with COPD who are prescribed or recommended smoking cessation pharmacotherapy | Using prospective chart review, we will assess the proportion of smoking patients with COPD who are prescribed or recommended smoking cessation pharmacotherapy at or after the index visit, in each analysis period | 12 months, broken into individual time series periods | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in respiratory medication prescriptions for eligible, smoking patients with COPD | Chart review will qualitatively record changes in respiratory medication prescriptions in all visits at or after the index visit, in each analysis period. We will include on treatment analyses for relevant outcomes (assessing outcomes in situations where patients a) successfully received the infographic; and b) situations where providers utilized the infographic). We will also analyze and adjust outcomes by provider characteristics (type, site, etc.) if event numbers are sufficient. | 12 months, broken into individual time series periods | 
| Changes in recommendations for non-pharmacotherapy smoking cessation strategies for eligible, smoking patients with COPD | Chart review will qualitatively record changes in recommendations for non-pharmacotherapy smoking cessation strategies in all visits at or after the index visit, in each analysis period. | 12 months, broken into individual time series periods | 
| Smoking cessation billing code changes for eligible, smoking patients with COPD. | Chart review will assess billing codes used for smoking cessation in all visits at or after the index visit, in each analysis period. We will include on treatment analyses for relevant outcomes (assessing outcomes in situations where patients a) successfully received the infographic; and b) situations where providers utilized the infographic). We will also analyze and adjust outcomes by provider characteristics (type, site, etc.) if event numbers are sufficient. | 12 months, broken into individual time series periods | 
| Smoking cessation rates for smoking patients with COPD seen a minimum of 6 months after the index visit, in each analysis period. | Chart review will assess for documentation of smoking cessation in all visits at or after the index visit, in each analysis period. | 6 months | 
| Smoking reduction rates for smoking patients with COPD seen a minimum of 6 months after the index visit, in each analysis period. | Chart review will assess for documentation of smoking reduction in all visits at or after the index visit, in each analysis period. We will include on treatment analyses for relevant outcomes (assessing outcomes in situations where patients a) successfully received the infographic; and b) situations where providers utilized the infographic). We will also analyze and adjust outcomes by provider characteristics (type, site, etc.) if event numbers are sufficient. | 6 months | 
| Changes in number of spirometry referrals for COPD or query COPD (in smokers and non-smokers) | A review of the pulmonary function lab visits in each analysis period will assess whether there was an increase in the number of spirometry referrals from the enrolled physicians, and all physicians. | 12 months, broken into individual time series periods | 
| Tool uptake | Chart review will look for evidence of tool use with the patient at the visit in all visits at or after the index visit, in the intervention period. | 12 months | 
| Qualitative and quantitative user feedback for the tool | Exclusively throughout the intervention, electronic questionnaires and telephone interviews will be solicited to assess user feedback on: barriers/enablers to use, feasibility, effect on workflow, perceived usability, quality and impact on smoking cessation counseling delivery and effectiveness. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic obstructive pulmonary disease, COPD, smoking cessation, smoking