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Reducing Tobacco Use Disparities Among Low-Income Adults

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ClinicalTrials.gov Identifier: NCT03077737
Recruitment Status : Completed
First Posted : March 13, 2017
Last Update Posted : August 30, 2019
Sponsor:
Collaborators:
University of Illinois at Chicago
Northeastern Illinois University
Information provided by (Responsible Party):
Brian Hitsman, Northwestern University

Tracking Information
First Submitted Date  ICMJE March 1, 2017
First Posted Date  ICMJE March 13, 2017
Last Update Posted Date August 30, 2019
Actual Study Start Date  ICMJE April 21, 2017
Actual Primary Completion Date August 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2017)
  • 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.
  • Quitline treatment utilization [ Time Frame: Week 14 ]
    The proportion of participants who complete one or more additional quitline counseling calls.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 7, 2017)
  • Treatment engagement [ Time Frame: Week 6 ]
    Treatment engagement will be measured at 6 weeks after letter mailing, and operationalized as the proportion of participants who accept the proactive Quitline call and accept treatment as defined by completing the counseling session. Participants who return a Quitline call and accept treatment also will be counted as having engaged in treatment.
  • Treatment Utilization [ Time Frame: Week 14 ]
    Treatment utilization will be measured at 14 weeks and will be defined as the proportion of participants who complete ≥1 additional counseling calls and receive and use NRT.
  • Smoking Cessation [ Time Frame: Week 28 ]
    At 28 weeks, breath CO will be used to verify smoking cessation. Participants will be classified as abstinent if they report not smoking (not even a puff of a cigarette) for ≥7 days and have a CO ≤8 parts per million (ppm). Participants will be assumed to be smoking if they report smoking, cannot be reached to provide data, fail to provide a breath sample, or provide a breath sample that is >8 ppm. Participants who report abstinence at 28 weeks will be invited for an in-person visit for breath carbon monoxide (CO) measurement to bio-verify abstinence status.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2017)
Cost Evaluation [ Time Frame: Week 28 ]
The investigators will evaluate the cost effectiveness of the Choose to Change letter and automated voice/text messages compared to usual care by calculation the cost-effectiveness ratio as the average dollars spent per successful quit.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reducing Tobacco Use Disparities Among Low-Income Adults
Official Title  ICMJE Reducing Tobacco Use Disparities Among Adults In Safety Net Community Health Centers
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cigarette Smoking
  • Nicotine Dependence
Intervention  ICMJE
  • 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).
  • 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.
Study Arms  ICMJE
  • Experimental: Population health management
    Population health management for smoking cessation in low-income smokers: the Choose to Change intervention
    Intervention: Behavioral: Choose to Change
  • Active Comparator: Enhanced usual care
    Usual clinic-based care enhanced by an EHR system that can deliver an electronic referral for quitline treatment
    Intervention: Behavioral: Enhanced usual care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 28, 2019)
190
Original Estimated Enrollment  ICMJE
 (submitted: March 7, 2017)
530
Actual Study Completion Date  ICMJE August 31, 2018
Actual Primary Completion Date August 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03077737
Other Study ID Numbers  ICMJE 5U54CA203000( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Brian Hitsman, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE
  • University of Illinois at Chicago
  • Northeastern Illinois University
Investigators  ICMJE
Principal Investigator: Brian Hitsman, PhD Northwestern University Feinberg School of Medicine
PRS Account Northwestern University
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP