Reducing Tobacco Use Disparities Among Low-Income Adults
Primary Purpose
Cigarette Smoking, Nicotine Dependence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Choose to Change
Enhanced usual care
Sponsored by
About this trial
This is an interventional treatment trial for Cigarette Smoking focused on measuring Treatment access, Treatment utilization, Smoking cessation, Low income, Electronic health record system, Electronic referral
Eligibility Criteria
Inclusion criteria
- Men and women who are 18 years of age or older
- A patient who receives healthcare at one of the seven Near North Health Service Corporation community health centers in Chicago
- Daily or weekly cigarette smoker
- One or more healthcare visits within the past 12 months
Exclusion criteria
- Language preference other than English or Spanish for their healthcare
- No telephone number or address listed in the EHR system
- Lives with another patient who is already enrolled in the study
Sites / Locations
- Northwestern University Feingberg School of Medicine, Dept. of Preventive Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Population health management
Enhanced usual care
Arm Description
Population health management for smoking cessation in low-income smokers: the Choose to Change intervention
Usual clinic-based care enhanced by an EHR system that can deliver an electronic referral for quitline treatment
Outcomes
Primary Outcome Measures
Quitline Treatment Engagement
The number of participants who accepted the quitline call and accepted treatment as defined by enrolling in treatment and completing the first counseling session. Participants who returned a quitline call, enrolled in treatment, and completed the first counseling session were also counted as having engaged in treatment.
Quitline Treatment Utilization
The number of participants who completed one or more additional quitline counseling calls.
Smoking Cessation at Week 28 (32 Weeks After Enrollment)
Self-reported seven-day point-prevalence abstinence at week 28. Number of participants who reporting smoking cessation at week 28. Participants were classified as abstinent if they reported not smoking (not even a puff of a cigarette) for at least 7 days prior to the assessment.
Secondary Outcome Measures
Smoking Cessation at Week 14 (18 Weeks After Enrollment)
Self-reported seven-day point-prevalence abstinence at week 14. Participants were classified as abstinent if they reported not smoking (not even a puff of a cigarette) for at least 7 days prior to the assessment.
Full Information
NCT ID
NCT03077737
First Posted
March 1, 2017
Last Updated
January 13, 2022
Sponsor
Northwestern University
Collaborators
University of Illinois at Chicago, Northeastern Illinois University
1. Study Identification
Unique Protocol Identification Number
NCT03077737
Brief Title
Reducing Tobacco Use Disparities Among Low-Income Adults
Official Title
Reducing Tobacco Use Disparities Among Adults In Safety Net Community Health Centers
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
April 21, 2017 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
University of Illinois at Chicago, Northeastern Illinois University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Most smokers, especially those who are poor, do not receive smoking cessation treatment during their healthcare visits. This study is evaluating a novel population health management intervention for low-income smokers. Automated via an EHR system, which is bidirectionally linked with the Illinois Tobacco Quitline, the intervention comprises a mailed letter and text messaging designed to motivate low-income patients, most of whom are not ready to quit, to accept and use proactive quitline treatment. Increased access to free effective treatment via the integration of healthcare systems and state quitline services may be especially significant in its impact on low-income smokers who are underserved and who carry a much greater burden of tobacco-related disease.
Detailed Description
An estimated 26 million smokers still receive no treatment for their smoking during their primary care visits. Given the persistent clinical system, provider, and patient barriers to addressing smoking in primary care, especially for poor populations, an electronic health record (EHR)-automated population health management approach that directly links the healthcare system with public health services to engage all smokers may increase access to effective treatment. Increased access is especially significant for low-income smokers who are underserved and who carry a disproportionate burden of tobacco-related disease. While 90% of smokers are not ready to quit, many are interested in cutting down, and smoking reduction increases the likelihood of future quit attempts and smoking cessation. Based on self-determination theory, population outreach targeted to low-income smokers that offers them the choice to either quit or cut down as a first step towards cessation may increase their engagement in and utilization of smoking cessation treatment and likelihood of achieving abstinence. This 2-group randomized controlled trial will evaluate the effectiveness of a population health management intervention for smoking cessation in low-income smokers. Participants will be 530 diverse, low-income smokers of a large Federally Qualified Health Center (FQHC) in Chicago identified using its EHR system. Automated via the EHR system, participants will be mailed a letter on behalf of their providers that encourages smoking cessation or smoking reduction as a first step to quitting (Choose to Change; N=265). The letter will be paired with 5 text messages 2-3 days apart that are designed to reinforce the central messaging of the letter ("Choose to change and make your own goal"). All components of the Choose to Change intervention will be offered in English and Spanish. Two weeks after letter mailing and automated electronic referral, participants will receive a call from the Illinois Tobacco Quitline and offered free behavioral counseling and free nicotine replacement therapy (NRT; patch, gum, or lozenge) for smoking cessation or reduction. Treatment will continue as either accepted or initiated by participants for 28 weeks. Treatment outcomes will be transmitted directly from the Quitline server to the EHR system. Choose to Change will be compared with Enhanced Usual Care (N=265), in which an electronic referral for proactive Quitline treatment is made during a clinic visit. The primary study outcomes will be treatment engagement (initial counseling call completed) at 6 weeks, utilization (one or more additional counseling calls completed) at 14 weeks, and smoking cessation (bioverified 7-day point-prevalence abstinence) at 28 weeks. An exploratory aim is to examine moderators of intervention effects. An EHR-automated population health management intervention targeted to low-income smokers could reduce critical disparities in treatment access, utilization, and cessation. If determined to be effective, the Choose to Change intervention could be readily disseminated to 11 other FQHCs in Chicago, comprising 85 clinical sites that care for almost 500,000 low-income patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cigarette Smoking, Nicotine Dependence
Keywords
Treatment access, Treatment utilization, Smoking cessation, Low income, Electronic health record system, Electronic referral
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
190 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Population health management
Arm Type
Experimental
Arm Description
Population health management for smoking cessation in low-income smokers: the Choose to Change intervention
Arm Title
Enhanced usual care
Arm Type
Active Comparator
Arm Description
Usual clinic-based care enhanced by an EHR system that can deliver an electronic referral for quitline treatment
Intervention Type
Behavioral
Intervention Name(s)
Choose to Change
Intervention Description
Population-based letter outreach automated via the electronic health record system and text messaging targeted to low-income smokers. Paired with automated electronic referral for proactive quitline treatment (behavioral counseling plus nicotine replacement therapy).
Intervention Type
Behavioral
Intervention Name(s)
Enhanced usual care
Intervention Description
Enhanced usual care based on Ask, Advise and Refer in which an electronic referral for proactive quitline treatment (behavioral counseling plus nicotine replacement therapy) is made during a clinic visit.
Primary Outcome Measure Information:
Title
Quitline Treatment Engagement
Description
The number of participants who accepted the quitline call and accepted treatment as defined by enrolling in treatment and completing the first counseling session. Participants who returned a quitline call, enrolled in treatment, and completed the first counseling session were also counted as having engaged in treatment.
Time Frame
Week 6
Title
Quitline Treatment Utilization
Description
The number of participants who completed one or more additional quitline counseling calls.
Time Frame
Week 14
Title
Smoking Cessation at Week 28 (32 Weeks After Enrollment)
Description
Self-reported seven-day point-prevalence abstinence at week 28. Number of participants who reporting smoking cessation at week 28. Participants were classified as abstinent if they reported not smoking (not even a puff of a cigarette) for at least 7 days prior to the assessment.
Time Frame
Week 28
Secondary Outcome Measure Information:
Title
Smoking Cessation at Week 14 (18 Weeks After Enrollment)
Description
Self-reported seven-day point-prevalence abstinence at week 14. Participants were classified as abstinent if they reported not smoking (not even a puff of a cigarette) for at least 7 days prior to the assessment.
Time Frame
Week 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria
Men and women who are 18 years of age or older
A patient who receives healthcare at one of the seven Near North Health Service Corporation community health centers in Chicago
Daily or weekly cigarette smoker
One or more healthcare visits within the past 12 months
Exclusion criteria
Language preference other than English or Spanish for their healthcare
No telephone number or address listed in the EHR system
Lives with another patient who is already enrolled in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Hitsman, PhD
Organizational Affiliation
Northwestern University Feinberg School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University Feingberg School of Medicine, Dept. of Preventive Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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24073176
Citation
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Results Reference
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Reducing Tobacco Use Disparities Among Low-Income Adults
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