Improving Quitline Support Study

Tobacco Use Cessation Clinical Trial

— IQS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03538938
• Other study ID #: 2017-0553
• Secondary ID: Protocol Version
• Status: Completed
• Phase: Phase 4
• Start date: June 7, 2018
• Est. completion date: August 15, 2023

Study information

• Verified date: November 2023
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1316
• Est. completion date: August 15, 2023
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Use Cessation

Intervention

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.
• 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).
• 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.
• No SmokefreeTXT
Proactive information about enrolling in adjunctive SmokefreeTXT text messaging support is not offered.
• 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).
• No Financial Incentives for Treatment Engagement
No Financial Incentives for Treatment Engagement are offered.

Locations

Country	Name	City	State
United States	Wisconsin Tobacco Quit Line (service provided by Free & Clear, Inc.)	Seattle	Washington

Sponsors (4)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Consumer Wellness Solutions, George Washington University, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7-Day Point-Prevalence Abstinence	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.	6-months