Helping Poor Smokers Quit

Not Applicable

Completed

• Conditions: Nicotine Dependence Tobacco Product; Smoking, Cigarette; Tobacco Use; Smoking, Tobacco; Smoking (Tobacco) Addiction; Tobacco; Use, Rehabilitation; Nicotine Use Disorder; Smoking, Pipe; Tobacco Use Cessation; Smoking Cessation
• Interventions: Behavioral: Specialized Quitline; Behavioral: Basic Needs Navigator

• Registration Number: NCT03194958
• Lead Sponsor: Washington University School of Medicine

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.

Study Timeline

• Study Start: 2017-06-05
• Study First Submitted: 2017-06-19
• Study First Submitted QC: 2017-06-20
• Study First Posted: 2017-06-21
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-01
• Status Verified: 2023-12
• Results First Submitted: 2023-12-04
• Results First Submitted QC: 2023-12-04
• Last Update Submitted: 2023-12-04
• Results First Posted: 2023-12-26
• Last Update Posted: 2023-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1944

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Specialized Quitline with Basic Needs Navigator	Basic Needs Navigator	Participants receive enhanced quitline services with navigator
Specialized Quitline	Specialized Quitline	Participants will receive an enhanced version of the standard quitline services
Specialized Quitline with Basic Needs Navigator	Specialized Quitline	Participants receive enhanced quitline services with navigator
Standard Quitline with Basic Needs Navigator	Basic Needs Navigator	Participants receive standard quitline services with navigator

Primary Outcome Measures

Name	Time	Method
Abstinence 6-months	6 months post-baseline	Report 7-day point prevalence abstinence measured at 6-months post --baseline

Secondary Outcome Measures

Name	Time	Method
24hr Quit Attempt	6 months post-baseline	Report quitting smoking for at least 24 hours during intervention
Abstinence 3-months	3 months post-baseline	Report 7-day point prevalence abstinence measured at 3-months post-baseline

Trial Locations

Locations (1)

Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States