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Completed

NCT Number: NCT03538938

Improving Quitline Support Study

This study seeks to evaluate ways to improve outcomes for low-education, uninsured or Medicaid-eligible smokers who do not successfully quit with standard telephone quit line treatment. The study will use an efficient factorial study design to evaluate four evidence-based strategies to improve follow-up care offered by the Wisconsin Tobacco Quit Line (WTQL) to socioeconomically disadvantaged callers who report smoking four months following initial WTQL treatment comprising a single counseling call and 2-week supply of a single nicotine replacement therapy. These strategies include: increasing the intensity of nicotine replacement medication (among those medically cleared to use such medications), increasing the intensity of WTQL counseling, helping callers enroll in an evidence-based smoking cessation texting support program (SmokefreeTXT), and offering moderate financial incentives for engagement in counseling and SmokefreeTXT.

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Key information

Conditions

Tobacco Use Cessation Behavior Health Behavior Smoking Smoking Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Wisconsin Tobacco Quit Line (service provided by Free & Clear, Inc.)

Seattle, Washington, 98104, United States

About this study

This study seeks to evaluate ways to improve outcomes for low-education, uninsured or Medicaid-eligible smokers who do not successfully quit with standard telephone quit line treatment. The study will use an efficient factorial study design to evaluate four evidence-based strategies to improve follow-up care offered by the Wisconsin Tobacco Quit Line (WTQL) to socioeconomically disadvantaged callers who report smoking four months following initial WTQL treatment comprising a single counseling call and 2-week supply of a single nicotine replacement therapy. The four factors (strategies) to be studied include: (1) Quit line counseling intensity (1 vs 4 proactive calls); (2) Nicotine replacement therapy (NRT) intensity (Patch for 2 weeks vs Patch+Lozenge for 4 weeks); (3) SmokefreeTXT text messages (proactive enrollment vs none); and (4) financial incentives for treatment engagement (vs none). The study design is a fully-crossed 4-factor factorial design. The primary aim is: Assessment of the main and interactive effects of the four treatment factors on biochemically-confirmed 7-day point-prevalence abstinence at the 6-month followup. Secondary aims include testing: (1) self-reported abstinence at 12 weeks post-quit; (2) continuous abstinence between 1 and 6 months; (3) cost-effectiveness; and (4) moderators of treatment engagement and mediators of treatment effectiveness on 6-month abstinence.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Uninsured, covered by BadgerCareWisconsin or another Medicaid program, or has no more than a high school education
  • Lives in Wisconsin
  • Age 18 or older
  • English speaking
  • Must provide a unique telephone number not already registered in the Wisconsin Tobacco Quit Line (WTQL) database for this study (to prevent duplicate enrollment and to ensure that only one person per household enrolls)
  • Must have completed standard WTQL treatment including at least one counseling call 2.5-18 months prior to study recruitment
  • Reported smoking at least 6 of the last 7 days at the WTQL follow-up enrollment call (2.5-18 months after completing standard WTQL treatment), with at least 5 cigarettes smoked on 1 or more days
  • Willing to set a new quit day within 2 weeks

Exclusion criteria

  • Pregnancy, breastfeeding, or planning to become pregnant in the next 6 months at the time of study enrollment

Treatment and study plan

1-Call Quitline Counseling

Behavioral

The 1-Call Quitline Counseling will be provided by the Wisconsin Tobacco Quit Line (WTQL) and consists of 1 proactive call using a standard, evidence-based protocol lasting approximately 20 minutes; ad hoc calls that are initiated by the participant are also available.

4-Call Quitline Counseling

Behavioral

The 4-Call Quitline Counseling will be provided by the Wisconsin Tobacco Quit Line (WTQL) and consists of 4 proactive calls that use a standard, evidence-based protocol with each call lasting approximately 20 minutes; ad hoc calls that are initiated by the participant are also available.

Nicotine patch

Drug

Nicotine Patch treatment will consist of a two week supply of over-the-counter nicotine patches (21 mg for those who smoke 10 or more cigarettes per day (CPD); 14 mg for those who smoke fewer than 10 CPD).

Nicotine Patch and Nicotine Lozenge

Drug

The Nicotine Patch treatment will consist of a four week supply of over-the-counter nicotine patches (21 mg for those who smoke 10 or more cigarettes per day (CPD); 14 mg for those who smoke fewer than 10 CPD); the Nicotine Lozenge treatment will consist of a four week supply of over-the-counter nicotine lozenges (2-mg dose for those who do not smoke within 30 minutes of waking; 4-mg dose for those who smoke within 30 minutes of waking).

SmokefreeTXT

Behavioral

SmokefreeTXT support is a national program offered at no cost to users (apart from data/minute costs charged by cellular providers about which enrollees are advised at enrollment) and is sponsored by the National Cancer Institute. This program sends up to 5 messages per day for up to 2 weeks prior to the target quit day and 6 weeks following the target quit day (total duration may be longer if participants elect to change the target quit day). The text messages offer tips to help enrollees achieve their goal of quitting smoking and offer real-time interactive tips when participants text in responses indicating cravings, negative moods, or slips. Participants have the option to reset quit dates and have the option to unsubscribe at any time by texting STOP to the program.

No SmokefreeTXT

Behavioral

Proactive information about enrolling in adjunctive SmokefreeTXT text messaging support is not offered.

Financial Incentives for Treatment Engagement

Behavioral

Incentives for treatment engagement are for each counseling session and for staying enrolled in SmokefreeTXT for six weeks. These incentives are designed to bolster motivation to stay engaged in treatment and to offset the costs and effort of treatment engagement (in terms of cell phone minutes).

No Financial Incentives for Treatment Engagement

Behavioral

No Financial Incentives for Treatment Engagement are offered.

Primary outcomes

  1. 7-Day Point-Prevalence Abstinence

    Time frame: 6-months

    Participants will be coded as abstinent if they self-report no smoking for the past 7 days at the assessment endpoint (6 month follow-up) and provide a saliva sample for cotinine testing with a value of <4 ng/ml. Participants will be considered not abstinent if they are lost to follow-up, report any smoking in the past 7 days, return a saliva sample with cotinine greater than or equal to 4 ng/ml, or fail to return a usable saliva sample.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • Consumer Wellness Solutions
  • George Washington University
  • National Cancer Institute (NCI)

Registry information

Official study title

Improving Quitline Support Study: Optimizing Remotely Delivered Smoking Cessation Services for Low-Income Smokers

Acronym: IQS

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
May 29, 2018
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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