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Reducing Tobacco Use Disparities Among Low-Income Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03077737
Recruitment Status : Completed
First Posted : March 13, 2017
Last Update Posted : August 30, 2019
University of Illinois at Chicago
Northeastern Illinois University
Information provided by (Responsible Party):
Brian Hitsman, Northwestern University

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.

Condition or disease Intervention/treatment Phase
Cigarette Smoking Nicotine Dependence Behavioral: Choose to Change Behavioral: Enhanced usual care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reducing Tobacco Use Disparities Among Adults In Safety Net Community Health Centers
Actual Study Start Date : April 21, 2017
Actual Primary Completion Date : August 31, 2018
Actual Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Experimental: Population health management
Population health management for smoking cessation in low-income smokers: the Choose to Change intervention
Behavioral: 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).

Active Comparator: Enhanced usual care
Usual clinic-based care enhanced by an EHR system that can deliver an electronic referral for quitline treatment
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.

Primary Outcome Measures :
  1. Quitline treatment engagement [ Time Frame: Week 6 ]
    The proportion of participants who accept the quitline call and accept treatment as defined by enrolling in treatment and completing the first counseling session. Participants who return a quitline call, enroll in treatment, and complete the first counseling session will also be counted as having engaged in treatment.

  2. Quitline treatment utilization [ Time Frame: Week 14 ]
    The proportion of participants who complete one or more additional quitline counseling calls.

  3. Short-term smoking cessation [ Time Frame: Week 28 ]
    Bio-verified 7-day point-prevalence abstinence. Participants will be classified as abstinent if they report not smoking (not even a puff of a cigarette) for at least 7 days and have an expired carbon monoxide level less than or equal to 8 parts per million.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03077737

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United States, Illinois
Northwestern University Feingberg School of Medicine, Dept. of Preventive Medicine
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
University of Illinois at Chicago
Northeastern Illinois University
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Principal Investigator: Brian Hitsman, PhD Northwestern University Feinberg School of Medicine

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Responsible Party: Brian Hitsman, Associate Professor of Preventive Medicine, Northwestern University Identifier: NCT03077737    
Other Study ID Numbers: 5U54CA203000 ( U.S. NIH Grant/Contract )
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Brian Hitsman, Northwestern University:
Treatment access
Treatment utilization
Smoking cessation
Low income
Electronic health record system
Electronic referral
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders