Improving Quitline Support Study (IQS)

University of Wisconsin (UW)

Status and phase: Completed; Phase 4

Conditions: Tobacco Use Cessation

Treatments: Behavioral: Financial Incentives for Treatment Engagement; Behavioral: No Financial Incentives for Treatment Engagement; Behavioral: 1-Call Quitline Counseling; Drug: Nicotine patch; Behavioral: No SmokefreeTXT; Behavioral: SmokefreeTXT; Behavioral: 4-Call Quitline Counseling; Drug: Nicotine Patch and Nicotine Lozenge

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT03538938

UW20069 (Other Identifier)

A534252 (Other Identifier)

2017-0553

Protocol Version 11/18/2020 (Other Identifier)

SMPH\MEDICINE\TOBACCO RE (Other Identifier)

1R01CA218156-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,316 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Uninsured, covered by BadgerCareWisconsin or another Medicaid program, or has no more than a high school education
2. Lives in Wisconsin
3. Age 18 or older
4. English speaking
5. 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)
6. Must have completed standard WTQL treatment including at least one counseling call 2.5-18 months prior to study recruitment
7. 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
8. Willing to set a new quit day within 2 weeks

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

---

1,316 participants in 16 patient groups

1-Call, Patch, SmokefreeTXT, Financial Incentive

Experimental group

Description:

Participants will receive the following treatment combination: 1-Call Quitline Counseling, two weeks of Nicotine Patch, instruction in enrolling in SmokefreeTXT, and Financial Incentives for Treatment Engagement. The proactive counseling call will last approximately 20 minutes. The 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). SmokefreeTXT text messaging in support of cessation will consist of 6-8 weeks of text messages (up to 5 messages per day for up to two weeks prior to the target quit day and for six weeks following the target quit day). Financial Incentives for treatment engagement are for completing the counseling call and for staying enrolled in the SmokefreeTXT program for six weeks.

Treatment:

Behavioral: SmokefreeTXT

Drug: Nicotine patch

Behavioral: 1-Call Quitline Counseling

Behavioral: Financial Incentives for Treatment Engagement

1-Call, Patch, SmokefreeTXT, No Financial Incentive

Experimental group

Description:

Participants will receive the following treatment combination: 1-Call Quitline Counseling, two weeks of Nicotine Patch, instruction in enrolling in SmokefreeTXT, No Financial Incentives for Treatment Engagement. The proactive counseling call will last approximately 20 minutes. The 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). SmokefreeTXT text messaging in support of cessation will consist of 6-8 weeks of text messages (up to 5 messages per day for up to two weeks prior to the target quit day and for six weeks following the target quit day). Financial Incentives for treatment engagement will not be offered.

Treatment:

Behavioral: SmokefreeTXT

Drug: Nicotine patch

Behavioral: 1-Call Quitline Counseling

Behavioral: No Financial Incentives for Treatment Engagement

1-Call, Patch, No SmokefreeTXT, Financial Incentive

Experimental group

Description:

Participants will receive the following treatment combination: 1-Call Quitline Counseling, two weeks of Nicotine Patch, No SmokefreeTXT, and Financial Incentives for Treatment Engagement. The proactive counseling call will last approximately 20 minutes. The 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). SmokefreeTXT text messaging in support of cessation will not be offered proactively. Financial Incentives for treatment engagement are for completing the counseling call.

Treatment:

Behavioral: No SmokefreeTXT

Drug: Nicotine patch

Behavioral: 1-Call Quitline Counseling

Behavioral: Financial Incentives for Treatment Engagement

1-Call, Patch, No SmokefreeTXT, No Financial Incentive

Experimental group

Description:

Participants will receive the following treatment combination: 1-Call Quitline Counseling, two weeks of Nicotine Patch, No SmokeFreeTXT, and No Financial Incentives for Treatment Engagement. The proactive counseling call will last approximately 20 minutes. The 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). SmokefreeTXT text messaging in support of cessation will not be offered proactively. Financial Incentives for treatment engagement will not be offered.

Treatment:

Behavioral: No SmokefreeTXT

Drug: Nicotine patch

Behavioral: 1-Call Quitline Counseling

Behavioral: No Financial Incentives for Treatment Engagement

1-Call, Patch+Loz, SmokefreeTXT, Financial Incentive

Experimental group

Description:

Participants will receive the following: 1-Call Quitline Counseling, 4 weeks of Nicotine Patch and Nicotine Lozenges, instruction in enrolling in SmokefreeTXT, and Financial Incentives for Treatment Engagement. The proactive counseling call will last approximately 20 minutes. Patch treatment will consist of a 4 week supply of over-the-counter nicotine patches (21 mg if smoking 10 or more cigarettes per day (CPD); 14 mg if smoking fewer than 10 CPD); 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 will consist of 6-8 weeks of text messages (up to 5 messages per day for up to two weeks prior to the target quit day \[TQD\] and for 6 weeks following the TQD). The Financial Incentives are for completing the counseling call and for staying enrolled in the SmokefreeTXT program for 6 weeks.

Treatment:

Drug: Nicotine Patch and Nicotine Lozenge

Behavioral: SmokefreeTXT

Behavioral: 1-Call Quitline Counseling

Behavioral: Financial Incentives for Treatment Engagement

1-Call, Patch+Loz, SmokefreeTXT, No Financial Incentive

Experimental group

Description:

Participants will receive the following treatment combination: 1-Call Quitline Counseling, four weeks of Nicotine Patch and Nicotine Lozenges, instruction in enrolling in SmokefreeTXT, and No Financial Incentives for Treatment Engagement. The proactive counseling call will last approximately 20 minutes. Nicotine Patch treatment will consist of a 4-week supply of over-the-counter nicotine patches (21 mg if smoking 10 or more cigarettes per day (CPD); 14 mg if smoking fewer than 10 CPD); Lozenge treatment will consist of a 4-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 text messaging in support of cessation will consist of 6-8 weeks of text messages (up to 5 messages per day for up to 2 weeks prior to the target quit day and for six weeks following the target quit day). Financial Incentives for treatment engagement will not be offered.

Treatment:

Drug: Nicotine Patch and Nicotine Lozenge

Behavioral: SmokefreeTXT

Behavioral: 1-Call Quitline Counseling

Behavioral: No Financial Incentives for Treatment Engagement

1-Call, Patch+Loz, No SmokefreeTXT, Financial Incentive

Experimental group

Description:

Participants will receive the following treatment combination: 1-Call Quitline Counseling, four weeks of Nicotine Patch and Nicotine Lozenges, No SmokefreeTXT, and Financial Incentives for Treatment Engagement. The proactive counseling call will last approximately 20 minutes. 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); 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). No SmokefreeTXT text messaging in support of cessation will be offered proactively. The Financial Incentives for treatment engagement are for completing the counseling call.

Treatment:

Drug: Nicotine Patch and Nicotine Lozenge

Behavioral: No SmokefreeTXT

Behavioral: 1-Call Quitline Counseling

Behavioral: Financial Incentives for Treatment Engagement

1-Call, Patch+Loz, No SmokefreeTXT, No Financial Incentive

Experimental group

Description:

Participants will receive the following treatment combination: 1-Call Quitline Counseling, four weeks of Nicotine Patch and Nicotine Lozenges, No SmokefreeTXT, and No Financial Incentives for Treatment Engagement. The proactive counseling call will last approximately 20 minutes. The 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); 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 text messaging in support of cessation will not be offered proactively. Financial Incentives for treatment engagement will not be offered.

Treatment:

Drug: Nicotine Patch and Nicotine Lozenge

Behavioral: No SmokefreeTXT

Behavioral: 1-Call Quitline Counseling

Behavioral: No Financial Incentives for Treatment Engagement

4-Call, Patch, SmokefreeTXT, Financial Incentive

Experimental group

Description:

Participants will receive the following treatment combination:4-Call Quitline Counseling, two weeks of Nicotine Patch, instruction in enrolling in SmokefreeTXT, and Financial Incentives for Treatment Engagement. Each of the proactive counseling calls will last approximately 20 minutes. The 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). SmokefreeTXT text messaging in support of cessation will consist of 6-8 weeks of text messages (up to 5 messages per day for up to two weeks prior to the target quit day and for six weeks following the target quit day). The Financial Incentives for treatment engagement are for completing each of the four counseling calls and for staying enrolled in the SmokefreeTXT program for six weeks.

Treatment:

Behavioral: 4-Call Quitline Counseling

Behavioral: SmokefreeTXT

Drug: Nicotine patch

Behavioral: Financial Incentives for Treatment Engagement

4-Call, Patch, SmokefreeTXT, No Financial Incentive

Experimental group

Description:

Participants will receive the following treatment combination: 4-Call Quitline Counseling, two weeks of Nicotine Patch, instruction in enrolling in SmokefreeTXT, and No Financial Incentives for Treatment Engagement. Each of the proactive counseling calls will last approximately 20 minutes. The 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). SmokefreeTXT text messaging in support of cessation will consist of 6-8 weeks of text messages (up to 5 messages per day for up to two weeks prior to the target quit day and for six weeks following the target quit day). Financial Incentives for treatment engagement will not be offered.

Treatment:

Behavioral: 4-Call Quitline Counseling

Behavioral: SmokefreeTXT

Drug: Nicotine patch

Behavioral: No Financial Incentives for Treatment Engagement

4-Call, Patch, No SmokefreeTXT, Financial Incentive

Experimental group

Description:

Participants will receive the following treatment combination: 4-Call Quitline Counseling, two weeks of Nicotine Patch, No SmokefreeTXT, and Financial Incentives for Treatment Engagement. Each of the proactive counseling calls will last approximately 20 minutes. The 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). SmokefreeTXT text messaging in support of cessation will not be offered proactively. The Financial Incentives for treatment engagement are for completing each of the four counseling calls.

Treatment:

Behavioral: 4-Call Quitline Counseling

Behavioral: No SmokefreeTXT

Drug: Nicotine patch

Behavioral: Financial Incentives for Treatment Engagement

4-Call, Patch, No SmokefreeTXT, No Financial Incentive

Experimental group

Description:

Participants will receive the following treatment combination: 4-Call Quitline Counseling, two weeks of Nicotine Patch, No SmokefreeTXT, and No Financial Incentives for Treatment Engagement. Each of the proactive counseling calls will last approximately 20 minutes. The 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). SmokefreeTXT text messaging in support of cessation will not be offered proactively. Financial Incentives for treatment engagement will not be offered.

Treatment:

Behavioral: 4-Call Quitline Counseling

Behavioral: No SmokefreeTXT

Drug: Nicotine patch

Behavioral: No Financial Incentives for Treatment Engagement

4-Call, Patch+Loz, SmokefreeTXT, Financial Incentive

Experimental group

Description:

Participants will receive: 4-Call Quitline Counseling, 4 weeks of Nicotine Patch and Nicotine Lozenges, instruction in enrolling in SmokefreeTXT, and Financial Incentives for Treatment Engagement. Each counseling call will last approximately 20 min. Patch treatment will consist of a 4 week supply of over-the-counter (OTC) nicotine patches (21 mg for if smoking 10 or more cigarettes per day (CPD); 14 mg if smoking fewer than 10 CPD); Lozenge treatment will consist of a 4 week supply of OTC nicotine lozenges (2-mg dose for those who do not smoke within 30 min of waking; 4-mg dose for those who smoke within 30 min of waking). SmokefreeTXT in support of cessation will consist of 6-8 weeks of text messages (up to 5 messages per day for up to 2 weeks prior to the target quit day \[TQD\] and for 6 weeks following the TQD). Financial Incentives are for completing each of the 4 counseling calls and for staying enrolled in SmokefreeTXT for 6 weeks.

Treatment:

Drug: Nicotine Patch and Nicotine Lozenge

Behavioral: 4-Call Quitline Counseling

Behavioral: SmokefreeTXT

Behavioral: Financial Incentives for Treatment Engagement

4-Call, Patch+Loz, SmokefreeTXT, No Financial Incentive

Experimental group

Description:

Participants will receive the following treatment combination: 4-Call Quitline Counseling, four weeks of Nicotine Patch and Nicotine Lozenges, instruction in enrolling in SmokefreeTXT, and No Financial Incentives for Treatment Engagement. Each of the proactive counseling calls will last approximately 20 minutes. The Patch treatment will consist of a 4-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); Lozenge treatment will consist of a 4-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 in support of cessation will consist of 6-8 weeks of text messages (up to 5 messages per day for up to 2 weeks prior to the target quit day and for 6 weeks following the target quit day). Financial Incentives for treatment engagement will not be offered.

Treatment:

Drug: Nicotine Patch and Nicotine Lozenge

Behavioral: 4-Call Quitline Counseling

Behavioral: SmokefreeTXT

Behavioral: No Financial Incentives for Treatment Engagement

4-Call, Patch+Loz, No SmokefreeTXT, Financial Incentive

Experimental group

Description:

Participants will receive the following treatment combination: 4-Call Quitline Counseling, four weeks of Nicotine Patch and Nicotine Lozenge, No SmokefreeTXT, and Financial Incentives for Treatment Engagement. Each of the proactive counseling calls will last approximately 20 minutes. 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); 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 text messaging in support of cessation will not be offered proactively. The Financial Incentives for treatment engagement are for completing each of the four counseling calls.

Treatment:

Drug: Nicotine Patch and Nicotine Lozenge

Behavioral: 4-Call Quitline Counseling

Behavioral: No SmokefreeTXT

Behavioral: Financial Incentives for Treatment Engagement

4-Call, Patch+Loz, No SmokefreeTXT,No Financial Incentive

Experimental group

Description:

Participants will receive the following treatment combination: 4-Call Quitline Counseling, four weeks of Nicotine Patch and Nicotine Lozenges, No SmokefreeTXT, and No Financial Incentives for Treatment Engagement. Each of the proactive counseling calls will last approximately 20 minutes. The 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); 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 in support of cessation will not be offered proactively. Financial Incentives for treatment engagement will not be offered.

Treatment:

Drug: Nicotine Patch and Nicotine Lozenge

Behavioral: 4-Call Quitline Counseling

Behavioral: No SmokefreeTXT

Behavioral: No Financial Incentives for Treatment Engagement