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Reducing Tobacco Use Disparities Among Low-Income Adults

Reducing Tobacco Use Disparities Among Adults In Safety Net Community Health Centers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03077737
Enrollment
190
Registered
2017-03-13
Start date
2017-04-21
Completion date
2018-08-31
Last updated
2022-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cigarette Smoking, Nicotine Dependence

Keywords

Treatment access, Treatment utilization, Smoking cessation, Low income, Electronic health record system, Electronic referral

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.

Interventions

BEHAVIORALChoose 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).

BEHAVIORALEnhanced 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.

Sponsors

University of Illinois at Chicago
CollaboratorOTHER
Northeastern Illinois University
CollaboratorOTHER
Northwestern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Quitline Treatment EngagementWeek 6The 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 UtilizationWeek 14The number of participants who completed one or more additional quitline counseling calls.
Smoking Cessation at Week 28 (32 Weeks After Enrollment)Week 28Self-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

MeasureTime frameDescription
Smoking Cessation at Week 14 (18 Weeks After Enrollment)Week 14Self-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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Population Health Management
Population health management for smoking cessation in low-income smokers: the Choose to Change intervention 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).
97
Enhanced Usual Care
Usual clinic-based care enhanced by an EHR system that can deliver an electronic referral for quitline treatment 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.
93
Total190

Baseline characteristics

CharacteristicEnhanced Usual CareTotalPopulation Health Management
Age, Continuous48.8 years
STANDARD_DEVIATION 11.9
49.0 years
STANDARD_DEVIATION 11.3
49.2 years
STANDARD_DEVIATION 10.7
Ethnicity (NIH/OMB)
Hispanic or Latino
8 Participants16 Participants8 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
85 Participants174 Participants89 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
75 Participants156 Participants81 Participants
Race (NIH/OMB)
More than one race
6 Participants8 Participants2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
5 Participants11 Participants6 Participants
Race (NIH/OMB)
White
7 Participants15 Participants8 Participants
Sex/Gender, Customized
Females
65 Participants123 Participants58 Participants
Sex/Gender, Customized
Males
28 Participants77 Participants49 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

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.

Time frame: Week 6

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Population Health ManagementQuitline Treatment Engagement25 Participants
Enhanced Usual CareQuitline Treatment Engagement0 Participants
Primary

Quitline Treatment Utilization

The number of participants who completed one or more additional quitline counseling calls.

Time frame: Week 14

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Population Health ManagementQuitline Treatment Utilization21 Participants
Enhanced Usual CareQuitline Treatment Utilization0 Participants
Primary

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.

Time frame: Week 28

Population: Due to project timeline constraints, only the first 96 participants were followed for 32 weeks.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Population Health ManagementSmoking Cessation at Week 28 (32 Weeks After Enrollment)8 Participants
Enhanced Usual CareSmoking Cessation at Week 28 (32 Weeks After Enrollment)3 Participants
Secondary

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.

Time frame: Week 14

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Population Health ManagementSmoking Cessation at Week 14 (18 Weeks After Enrollment)9 Participants
Enhanced Usual CareSmoking Cessation at Week 14 (18 Weeks After Enrollment)3 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026