Clinical trial NCT04119934: Personalized Smoking Cessation Infographic in COPD
Official title: Personalized Biomedical Risk Assessment for Smoking Cessation in Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Smoking Cessation
Keywords: Chronic obstructive pulmonary disease
COPD
smoking cessation
smoking
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2019-10-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of clinicians in primary care and hospital settings in Toronto, Canada.

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of eligible, smoking patients with COPD who receive a smoking cessation counselling intervention
timeFrame: 12 months, broken into individual time series periods
measure: Proportions of eligible, smoking patients with COPD who are prescribed or recommended smoking cessation pharmacotherapy
timeFrame: 12 months, broken into individual time series periods
Secondary outcomes:
measure: Changes in respiratory medication prescriptions for eligible, smoking patients with COPD
timeFrame: 12 months, broken into individual time series periods
measure: Changes in recommendations for non-pharmacotherapy smoking cessation strategies for eligible, smoking patients with COPD
timeFrame: 12 months, broken into individual time series periods
measure: Smoking cessation billing code changes for eligible, smoking patients with COPD.
timeFrame: 12 months, broken into individual time series periods
measure: Smoking cessation rates for smoking patients with COPD seen a minimum of 6 months after the index visit, in each analysis period.
timeFrame: 6 months
measure: Smoking reduction rates for smoking patients with COPD seen a minimum of 6 months after the index visit, in each analysis period.
timeFrame: 6 months
measure: Changes in number of spirometry referrals for COPD or query COPD (in smokers and non-smokers)
timeFrame: 12 months, broken into individual time series periods
measure: Tool uptake
timeFrame: 12 months
measure: Qualitative and quantitative user feedback for the tool
timeFrame: 12 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
References:
citation: Anthonisen NR, Skeans MA, Wise RA, Manfreda J, Kanner RE, Connett JE; Lung Health Study Research Group. The effects of a smoking cessation intervention on 14.5-year mortality: a randomized clinical trial. Ann Intern Med. 2005 Feb 15;142(4):233-9. doi: 10.7326/0003-4819-142-4-200502150-00005.
citation: Chapman KR, Bourbeau J, Rance L. The burden of COPD in Canada: results from the Confronting COPD survey. Respir Med. 2003 Mar;97 Suppl C:S23-31. doi: 10.1016/s0954-6111(03)80022-7.
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citation: Voncken-Brewster V, Tange H, de Vries H, Nagykaldi Z, Winkens B, van der Weijden T. A randomized controlled trial evaluating the effectiveness of a web-based, computer-tailored self-management intervention for people with or at risk for COPD. Int J Chron Obstruct Pulmon Dis. 2015 Jun 8;10:1061-73. doi: 10.2147/COPD.S81295. eCollection 2015.