Helping Poor Smokers Quit

Study Overview
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Brief Summary
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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
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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.

Official Title
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Helping the Poor Quit Smoking: Specialized Quitlines and Meeting Basic Needs

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

Intervention / Treatment
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* Behavioral: Specialized Quitline
* Behavioral: Basic Needs Navigator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Quitline<br>Participants will receive standard Missouri quitline services | |
| Experimental: Specialized Quitline<br>Participants will receive an enhanced version of the standard quitline services | Behavioral: Specialized Quitline<br>* Very low-income smokers are different from other smokers in important ways not always addressed by standard quitline services. The research team and Alere staff has created custom protocols, scripts, prompts and other content to maximize intervention relevance and acceptability to very low-income smokers. Research Implementation Unit (RIU) coaches who will be delivering the Specialized Quitline services have received training from clinical quitline staff, the research team and 2-1-1 staff who have extensive experience with the target population. Focus areas for training and distinctive content and protocol for the Specialized Quitline include: health literacy, abstract vs. concrete language, lived experience, resource constraints, future orientation, getting cigarettes, living situation, phone/internet access.<br>|
| Experimental: Standard Quitline with Basic Needs Navigator<br>Participants receive standard quitline services with navigator | Behavioral: Basic Needs Navigator<br>* Navigators will: (1) identify and assess smokers' needs, including the reasons they called 2-1-1; (2) jointly generate solutions to address the needs; (3) develop plans to carry out the solutions, including; (4) help prioritize among multiple needs; (5) identify community resources that could help solve the problem; (6) determine eligibility for services; (7) help smokers access available resources by scheduling appointments and provide appointment reminders; (8) prepare smokers to interact with service agencies and/or act as an advocate on their behalf; (9) provide instrumental support such as arranging transportation; (10) actively intervene to resolve barriers to basic needs solutions; (11) oversee follow-up of problem solving actions; and (12) review progress made towards resolving unmet basic needs and adapt solutions accordingly.<br>|
| Experimental: Specialized Quitline with Basic Needs Navigator<br>Participants receive enhanced quitline services with navigator | Behavioral: Specialized Quitline<br>* Very low-income smokers are different from other smokers in important ways not always addressed by standard quitline services. The research team and Alere staff has created custom protocols, scripts, prompts and other content to maximize intervention relevance and acceptability to very low-income smokers. Research Implementation Unit (RIU) coaches who will be delivering the Specialized Quitline services have received training from clinical quitline staff, the research team and 2-1-1 staff who have extensive experience with the target population. Focus areas for training and distinctive content and protocol for the Specialized Quitline include: health literacy, abstract vs. concrete language, lived experience, resource constraints, future orientation, getting cigarettes, living situation, phone/internet access.<br>Behavioral: Basic Needs Navigator<br>* Navigators will: (1) identify and assess smokers' needs, including the reasons they called 2-1-1; (2) jointly generate solutions to address the needs; (3) develop plans to carry out the solutions, including; (4) help prioritize among multiple needs; (5) identify community resources that could help solve the problem; (6) determine eligibility for services; (7) help smokers access available resources by scheduling appointments and provide appointment reminders; (8) prepare smokers to interact with service agencies and/or act as an advocate on their behalf; (9) provide instrumental support such as arranging transportation; (10) actively intervene to resolve barriers to basic needs solutions; (11) oversee follow-up of problem solving actions; and (12) review progress made towards resolving unmet basic needs and adapt solutions accordingly.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abstinence 6-months | Report 7-day point prevalence abstinence measured at 6-months post --baseline | 6 months post-baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abstinence 3-months | Report 7-day point prevalence abstinence measured at 3-months post-baseline | 3 months post-baseline | 
| 24hr Quit Attempt | Report quitting smoking for at least 24 hours during intervention | 6 months post-baseline |