Clinical trial NCT02713594: Wisconsin Tobacco Quit Line Medicaid Incentive Evaluation
Official title: Wisconsin Tobacco Quit Line Centers for Medicaid Services Striving To Quit Evaluation Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Smoking Cessation
Nicotine Dependence
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2016-03-18
Enrollment: 1900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study is designed to test the hypotheses that financial incentives can increase both participation in smoking cessation treatment and resulting cessation rates, when they are offered to BadgerCare Plus (Medicaid) smokers as part of their health care.

Detailed description: Previous research on providing incentives for healthy behaviors has shown that financial incentives can increase treatment participation and boost outcomes when they are tied to participation in evidence based treatments. However, most of this research has been done in laboratory settings and in relatively small clinical trials. This study is designed to test the hypotheses that incentives can increase both participation in smoking cessation treatment and resulting cessation rates, when they are offered to Wisconsin BadgerCare Plus (Medicaid) smokers as part of their health care. If successful, this treatment approach could be used more broadly to reduce the considerable financial and personal costs associated with smoking-related disease.

In this study, Medicaid-eligible smokers were recruited from primary care clinics and from callers to the Wisconsin Tobacco Quit Line (WTQL) with randomization a Control condition and an Incentive condition. All participants were offered five cessation calls from the WTQL and participants were encouraged by WTQL coaches to obtain cessation medication from their primary care providers. All participants received payment for completing a baseline assessment ($40) and a 6-month smoking test ($40). Only Incentive condition participants received additional compensation for taking counseling calls ($30 per completed call) and for biochemically-verified abstinence at the 6-month visit ($40).

Eligibility criteria: Inclusion Criteria:

* enrollment in Wisconsin Medicaid (BadgerCare Plus)
* resides in study area (one of 25 counties)
* 18 or older
* English or Spanish speaking
* has smoked daily (at least 5 cigarettes each day) over the last week
* willingness to attend visits at his/her PCC (primary care clinic) or go to a testing site at baseline and 6 months (2 times over a 6 month period), provide urine samples or participate in exhaled carbon monoxide testing, and complete follow-up phone calls from the WTQL
* willingness to inform the WTQL as to any change in address, phone number, clinic attended, or health plan.

Exclusion Criteria:

* not enrolled in Wisconsin Medicaid (BadgerCare Plus)
* not reside in study area
* less than 18 years of age
* not English or Spanish speaking
* does not smoke daily (at least 5 cigarettes each day) over the last week
* not willing to attend visits at his/her PCC (primary care clinic) or alternative testing site at baseline and 6 months (2 times over a 6 month period), provide urine or exhaled carbon monoxide samples, and complete follow-up phone calls.
* not willing to inform the WTQL as to any change in address, phone number, clinic attended, or health plan.

Primary outcomes:
measure: Abstinence From Smoking
timeFrame: Measured 6 months after enrollment at follow-up assessment
Secondary outcomes:
measure: Engagement in Treatment
timeFrame: Measured 6 months after enrollment at follow-up assessment
measure: Cost-effectiveness
timeFrame: Measured 6 months after enrollment
Other outcomes:
Locations:
Study officials:
affiliation: University of Wisconsin--CTRI
name: Timothy b Baker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fraser DL, Fiore MC, Kobinsky K, Adsit R, Smith SS, Johnson ML, Baker TB. A Randomized Trial of Incentives for Smoking Treatment in Medicaid Members. Am J Prev Med. 2017 Dec;53(6):754-763. doi: 10.1016/j.amepre.2017.08.027. Epub 2017 Nov 2.