Reducing Tobacco Use Disparities Among Low-Income Adults

NCT ID: NCT03077737

Last Updated: 2022-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-21
• Study Completion Date: 2018-08-31

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.

Conditions

Cigarette Smoking; Nicotine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Population health management

Population health management for smoking cessation in low-income smokers: the Choose to Change intervention

Group Type: EXPERIMENTAL

Choose to Change

Intervention Type: BEHAVIORAL

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).

Enhanced usual care

Usual clinic-based care enhanced by an EHR system that can deliver an electronic referral for quitline treatment

Group Type: ACTIVE_COMPARATOR

Enhanced usual care

Intervention Type: BEHAVIORAL

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.

Interventions

Choose to Change

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

Enhanced usual care

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Men and women who are 18 years of age or older

2. A patient who receives healthcare at one of the seven Near North Health Service Corporation community health centers in Chicago

3. Daily or weekly cigarette smoker

4. One or more healthcare visits within the past 12 months

Exclusion Criteria

1. Language preference other than English or Spanish for their healthcare

2. No telephone number or address listed in the EHR system

3. Lives with another patient who is already enrolled in the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Illinois at Chicago

OTHER

Sponsor Role: collaborator

Northeastern Illinois University

OTHER

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Brian Hitsman

Associate Professor of Preventive Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brian Hitsman, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University Feinberg School of Medicine

Locations

Northwestern University Feingberg School of Medicine, Dept. of Preventive Medicine

Chicago, Illinois, United States

Countries

United States

References

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Reference Type: BACKGROUND

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Hitsman B, Matthews PA, Papandonatos GD, Cameron KA, Rittner SS, Mohanty N, Long T, Ackermann RT, Ramirez E, Carr J, Cordova E, Bridges C, Flowers-Carson C, Giachello AL, Hamilton A, Ciecierski CC, Simon MA. An EHR-automated and theory-based population health management intervention for smoking cessation in diverse low-income patients of safety-net health centers: a pilot randomized controlled trial. Transl Behav Med. 2022 Oct 7;12(9):892-899. doi: 10.1093/tbm/ibac026.

Reference Type: DERIVED

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

5U54CA203000

Identifier Type: NIH

Identifier Source: org_study_id

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