Clinical trial NCT03538938: Improving Quitline Support Study
Official title: Improving Quitline Support Study: Optimizing Remotely Delivered Smoking Cessation Services for Low-Income Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tobacco Use Cessation
Keywords: Smoking
Smoking cessation
Quitline
Nicotine Replacement Therapy
SmokefreeTXT text messages
Financial incentives
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: George Washington University
name: Consumer Wellness Solutions
name: National Cancer Institute (NCI)
First posted: 2018-05-29
Enrollment: 1316
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Four-factor fully-crossed factorial design
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: 7-Day Point-Prevalence Abstinence
timeFrame: 6-months
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Wisconsin Tobacco Quit Line (service provided by Free & Clear, Inc.)
state: Washington
Study officials:
affiliation: University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
name: Danielle E. McCarthy, PhD
role: PRINCIPAL_INVESTIGATOR
References: