Helping Poor Smokers Quit

The Washington University

Status: Completed

Conditions: Tobacco Dependence; Smoking, Cigarette; Tobacco Use Cessation; Nicotine Use Disorder; Nicotine Dependence Tobacco Product; Smoking, Tobacco; Tobacco Smoking; Nicotine Dependence, Cigarettes; Smoking; Tobacco Use; Smoking Cessation; Smoking (Tobacco) Addiction; Tobacco; Use, Rehabilitation; Nicotine Dependence; Smoking, Pipe

Treatments: Behavioral: Basic Needs Navigator; Behavioral: Specialized Quitline

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03194958

R01CA201429 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,944 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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1,944 participants in 4 patient groups

Standard Quitline

No Intervention group

Description:

Participants will receive standard Missouri quitline services

Specialized Quitline

Experimental group

Description:

Participants will receive an enhanced version of the standard quitline services

Treatment:

Behavioral: Specialized Quitline

Standard Quitline with Basic Needs Navigator

Experimental group

Description:

Participants receive standard quitline services with navigator

Treatment:

Behavioral: Basic Needs Navigator

Specialized Quitline with Basic Needs Navigator

Experimental group

Description:

Participants receive enhanced quitline services with navigator

Treatment:

Behavioral: Basic Needs Navigator

Behavioral: Specialized Quitline