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
|Condition or disease||Intervention/treatment||Phase|
|Cigarette Smoking Nicotine Dependence||Behavioral: Choose to Change Behavioral: Enhanced usual care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||190 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT03077737
|United States, Illinois|
|Northwestern University Feingberg School of Medicine, Dept. of Preventive Medicine|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Brian Hitsman, PhD||Northwestern University Feinberg School of Medicine|