NCT04119934

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 9, 2019

Completed
3.3 years until next milestone

Study Start

First participant enrolled

January 9, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

July 7, 2026

Status Verified

February 1, 2023

Enrollment Period

1.6 years

First QC Date

October 7, 2019

Last Update Submit

July 3, 2026

Conditions

Keywords

Chronic obstructive pulmonary diseaseCOPDsmoking cessationsmoking

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • Changes in respiratory medication prescriptions for eligible, smoking patients with COPD

    12 months, broken into individual time series periods

  • Changes in recommendations for non-pharmacotherapy smoking cessation strategies for eligible, smoking patients with COPD

    12 months, broken into individual time series periods

  • Smoking cessation billing code changes for eligible, smoking patients with COPD.

    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.

    6 months

  • Smoking reduction rates for smoking patients with COPD seen a minimum of 6 months after the index visit, in each analysis period.

    6 months

  • +3 more secondary outcomes

Study Arms (2)

Control - None

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

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

Interventions

A personalized smoking cessation infographic is provided to the physician/NP alongside the patient's regular spirometry report.

Intervention - Smoking cessation infographic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of clinicians in primary care and hospital settings in Toronto, Canada.

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Related 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.

    PMID: 15710956BACKGROUND
  • 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.

    PMID: 12647940BACKGROUND
  • 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.

    PMID: 16279970BACKGROUND
  • 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.

    PMID: 27486205BACKGROUND
  • 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.

    PMID: 26089656BACKGROUND

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveSmoking CessationSmoking

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHealth BehaviorBehavior

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2019

First Posted

October 9, 2019

Study Start

January 9, 2023

Primary Completion

July 31, 2024

Study Completion

July 31, 2024

Last Updated

July 7, 2026

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations