Personalized Smoking Cessation Infographic in COPD

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04119934
• Other study ID #: 19-231
• Status: Recruiting
• Start date: January 9, 2023
• Est. completion date: July 2024

Study information

• Verified date: February 2023
• Source: Unity Health Toronto
• Contact: Samir Gupta, MD, MSc
• Phone: (416) 864-6060
• Email: samir.gupta[@]unityhealth.to
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Smoking Cessation

Intervention

Behavioral:
• Smoking Cessation Intervention Tool
A personalized smoking cessation infographic is provided to the physician/NP alongside the patient's regular spirometry report.

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Unity Health Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (5)

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. — View 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. — View Citation

Schuster MA, McGlynn EA, Brook RH. How good is the quality of health care in the United States? 1998. Milbank Q. 2005;83(4):843-95. doi: 10.1111/j.1468-0009.2005.00403.x. No abstract available. — View 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. — View Citation

Zafari Z, Sin DD, Postma DS, Lofdahl CG, Vonk J, Bryan S, Lam S, Tammemagi CM, Khakban R, Man SFP, Tashkin D, Wise RA, Connett JE, McManus B, Ng R, Hollander Z, Sadatsafavi M. Individualized prediction of lung-function decline in chronic obstructive pulmonary disease. CMAJ. 2016 Oct 4;188(14):1004-1011. doi: 10.1503/cmaj.151483. Epub 2016 Aug 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Statistics Canada. Canadian Tobacco Use Monitoring Survey (CTUMS): Detailed Information from February to June 2006