Clinical trial NCT03194958: Helping Poor Smokers Quit
Official title: Helping the Poor Quit Smoking: Specialized Quitlines and Meeting Basic Needs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Smoking, Tobacco
Smoking, Cigarette
Smoking, Pipe
Smoking (Tobacco) Addiction
Smoking
Tobacco Use
Tobacco Dependence
Tobacco Use Cessation
Tobacco Smoking
Tobacco; Use, Rehabilitation
Nicotine Dependence
Nicotine Use Disorder
Nicotine Dependence, Cigarettes
Nicotine Dependence Tobacco Product
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2017-06-21
Enrollment: 1944
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Using a 2x2 randomized factorial design, we will conduct a statewide field trial in Missouri to compare the relative and combined effects of these two strategies for augmenting an existing, evidence-based tobacco quitline program. Among 2000 low-income smokers, half will receive standard Missouri quitline services and half will receive new Specialized Quitline services targeted to this group. In each of these groups, half also will receive calls from a trained navigator to help them address unmet Basic Needs and the accompanying psychological distress that act as barriers to smoking cessation.

Detailed description: 2-1-1 information specialists will deliver standard service, then ask a random number of callers per day if they would be willing to answer a few health questions as part of a new 2-1-1 service. Callers eligible to receive the invitation to screen for study eligibility will be: Missouri residents, calling for themselves, English-speaking, and not in acute crisis. Eligible smokers will then be asked if they are willing to share their contact information with a research team conducting a study to help smokers quit. Smokers who agree to share their contact information will be considered "enrolled". Trained 2-1-1 operators will record all recruitment screening data in a secure electronic database that is shared with research staff. Research staff will attempt to reach enrolled smokers by phone by the next business day.

Alere, through the Missouri Tobacco Quitline, will provide quitline services to smokers in all study conditions. Contact information and study group assignment for smokers will be provided to Alere via secure data transfer.

Eligibility criteria: Inclusion Criteria:

* 18 years and older
* Missouri resident
* English speaking
* Not in crisis
* Smoke cigarettes every day of the week
* Planning to quit smoking in the next 30 days
* Comfortable receiving calls from smoking expert and project team
* Willing to provide phone numbers to be reached

Exclusion Criteria:

* Pregnant or planning to become pregnant in the next 3 months
* Currently breastfeeding
* Insurance through employer
* Currently enrolled in smoking quitline

Primary outcomes:
measure: Abstinence 6-months
timeFrame: 6 months post-baseline
Secondary outcomes:
measure: Abstinence 3-months
timeFrame: 3 months post-baseline
measure: 24hr Quit Attempt
timeFrame: 6 months post-baseline
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Matthew Kreuter, PhD
role: PRINCIPAL_INVESTIGATOR
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