Trials / Completed
CompletedNCT03538938
Improving Quitline Support Study
Improving Quitline Support Study: Optimizing Remotely Delivered Smoking Cessation Services for Low-Income Smokers
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 1,316 (actual)
- Sponsor
- University of Wisconsin, Madison · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | 1-Call Quitline Counseling | 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. |
| BEHAVIORAL | 4-Call Quitline Counseling | 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. |
| DRUG | Nicotine patch | 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). |
| DRUG | Nicotine Patch and Nicotine Lozenge | 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). |
| BEHAVIORAL | SmokefreeTXT | 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. |
| BEHAVIORAL | No SmokefreeTXT | Proactive information about enrolling in adjunctive SmokefreeTXT text messaging support is not offered. |
| BEHAVIORAL | Financial Incentives for Treatment Engagement | 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). |
| BEHAVIORAL | No Financial Incentives for Treatment Engagement | No Financial Incentives for Treatment Engagement are offered. |
Timeline
- Start date
- 2018-06-07
- Primary completion
- 2023-08-15
- Completion
- 2023-08-15
- First posted
- 2018-05-29
- Last updated
- 2024-07-12
- Results posted
- 2024-07-12
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03538938. Inclusion in this directory is not an endorsement.