Interventions to Help More Low-income Smokers Quit (SFH)

Expanding Population-level Interventions to Help More Low-income Smokers Quit

In a Hybrid Type 2 randomized trial, 1,980 low-income smokers from nine states with high smoking prevalence will be recruited from 2-1-1 helplines to receive either current standard practice (Quitline) or expanded services (Quitline + Smoke Free Homes) to increase tobacco cessation.

Study Overview

• Status: Completed
• Conditions: Tobacco Use Cessation; Smoking Behaviors; Health Disparity
• Intervention / Treatment: Behavioral: Tobacco Quitline; Behavioral: Smoke Free Home

Detailed Description

There is an urgent need to engage more low-income smokers in activities that lead to quitting. The current standard of practice for population-level tobacco treatment is phone-based cessation counseling delivered by state tobacco quitlines. But quitline services are restricted to smokers who are ready to quit in the next 30 days, a criterion met by only 20-30% of low-income smokers. Thus, current population level tobacco treatment has nothing to offer 70-80% of low-income U.S. smokers. Based on extensive preliminary research by our study team, the investigators assert that offering a pre-cessation intervention - Smoke Free Homes - to low-income smokers who are not yet ready to quit will: (1) engage more smokers in using proven interventions; (2) increase their readiness to quit and quit attempts; (3) reduce the number of cigarettes they smoke per day; and (4) increase cessation. These benefits will accrue in addition to reducing exposure to harmful secondhand smoke for non-smokers in the home. In a Hybrid Type 2 randomized trial, 1,980 low-income smokers from nine states with high smoking prevalence will be recruited from 2-1-1 helplines to receive either current standard practice (Quitline) or expanded services (Quitline + Smoke Free Homes). In the latter condition, smokers will be offered cessation counseling first, just like current standard practice, but those who decline will then be offered Smoke Free Homes. At 3-month followup, those in the latter condition who accepted quitline services but did not quit will be offered Smoke Free Homes, and those that accepted Smoke Free Homes but did not quit will be offered quitline services. The effectiveness portion of the Hybrid Type 2 design (Aim 1) will use intent-to-treat analyses to compare group differences at 3- and 6-month follow-up in 7- and 30-day point prevalence abstinence with biochemical verification, as well as 24-hour quit attempts and cigarettes smoked per day. The implementation portion of the Hybrid Type 2 design (Aims 2-3) will measure smokers' acceptance and use of the interventions, as well as cost-effectiveness and cost-benefits of adding Smoke Free Homes to quitline services. With rates of smoking and smoking-related cancers much higher in low-income populations and treatment costs exceeding tens of billions of dollars annually in Medicaid alone, this large-scale practical trial will provide strong evidence with high external validity to answer an important policy question: Will changing the standard practice for population-level treatment of smoking result in increased cessation in low-income populations?

• Study Type: Interventional
• Enrollment (Actual): 1982
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matthew Kreuter, Ph.D.; Phone Number: 314-935-3701; Email: mkreuter@wustl.edu
• Study Contact Backup: Name: Amy McQueen, PhD; Phone Number: 314-935-3715; Email: amcqueen@wustl.edu

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age ≥21
• English-speaking
• Daily smoker
• Does not have a full home smoking ban
• Recruited from those who called 2-1-1 for themselves and are not in acute crisis

Exclusion Criteria:

-Pregnant women, because recommended tobacco cessation actions differ for this subset of smokers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tobacco Quitline only; Smokers in this study group will be offered their state Tobacco Quitline programs	Behavioral: Tobacco Quitline; Tobacco quitlines provide phone counseling from a quit coach, often supplemented with NRT (nicotine replacement therapy), a quit guide, text messages, or other support. Smokers can call directly or consent to be called by the quitline ("fax-back").
Experimental: Tobacco Quitline plus Smoke Free Homes; Smokers in this study group will be offered their state Tobacco Quitline programs, but if they decline, they will be offered a Smoke Free Homes intervention	Behavioral: Tobacco Quitline; Tobacco quitlines provide phone counseling from a quit coach, often supplemented with NRT (nicotine replacement therapy), a quit guide, text messages, or other support. Smokers can call directly or consent to be called by the quitline ("fax-back").; Behavioral: Smoke Free Home; The intervention guides participants though a 5-step process: (1) deciding to create a smoke-free home; (2) talking about it with household members; (3) setting a date for the home to become smoke-free; (4) making the home smoke-free; and (5) keeping the home smoke-free. Progress from one step to the next is facilitated over a 6-week period by three mailings sent to participants' homes and one telephone counseling call delivered by a trained smoke free homes coach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
7day point prevalence for smoking	Proportion of participants who have 7 day smoking abstinence	6 month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants who accept the tobacco quitline program	All participants are asked at baseline if they are interested in trying the <STATE> tobacco quitline. Some participants are asked this question again at the 3-month follow-up; The probability is the proportion who answer "yes".	Baseline and 3-month follow-up

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Matthew Kreuter, Ph.D., Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2020
• Primary Completion (Actual): September 29, 2023
• Study Completion (Actual): September 29, 2023

Study Registration Dates

• First Submitted: March 10, 2020
• First Submitted That Met QC Criteria: March 16, 2020
• First Posted (Actual): March 17, 2020

Study Record Updates

• Last Update Posted (Estimated): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 202002125-1001; 1R01CA235773-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The HCRL Data Center will make the datasets and other materials available without cost to researchers and analysts after a data sharing agreement is completed. Consistent with NIH guidelines, the data sharing agreement: (1) records a request for data use and detailed description of the intent of use; (2) details the study's publication guidelines, including acknowledging and citing project personnel as appropriate; (3) ensures IRB compliance, including not using these data for non-research purposes; and (4) stipulates that users will not share or distribute the data to others without written permission.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No