Striving to Quit-Wisconsin Tobacco Quit Line

December 5, 2016 updated by: University of Wisconsin, Madison

Striving to Quit: Wisconsin Tobacco Quit Line Tobacco Cessation Research

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 Medicaid BadgerCare Plus members.

Study Overview

Detailed Description

Aim 1: To determine the extent to which contingent financial "treatment incentives" (i.e., incentives for biochemical verification visits, treatment engagement, and abstinence) versus "attendance incentives" (i.e., incentives for only attending the biochemical verification visits), increase rates of smoking cessation . Participants will be BadgerCare Plus tobacco users who enroll in Wisconsin Tobacco Quit Line (WTQL) services.

Aim 2: To determine the extent to which treatment incentives vs. attendance incentives increase rates of engagement in smoking cessation treatment through the WTQL when offered to BadgerCare Plus members who smoke.

Aim 3: To determine the cost-effectiveness of the smoking cessation program when paired with treatment incentives and when paired with attendance incentives.

Aim 4: To identify moderating and mediational effects regarding the clinical benefit of incentivized smoking treatment

Aim 5: To determine the reach of an incentivized smoking cessation treatment that depends upon primary care clinic staff, a fax-to-quit referral mechanism and a state quit line.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • enrollment in Wisconsin Medicaid (BadgerCare Plus)
  • resides in study area (one of 25 counties)
  • member of participating HMOs
  • 18 or older
  • English 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) every 6 months (3 times over a 12 month period), provide urine samples, and complete follow-up phone calls
  • 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
  • not a member participating HMOs
  • less than 18 years of age
  • not English 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) every 6 months (3 times over a 12 month period), provide urine 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment incentives
Incentives for biochemical verification visits, treatment engagement, and abstinence
Treatment incentives - incentives for biochemical verification visits, treatment engagement and abstinence
Active Comparator: Attendance incentive
Incentives for only attending the biochemical verification visits
Attendance Incentives - incentives for only attending the biochemical verification visits

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abstinence from smoking
Time Frame: Measured 6 months after enrollment at follow-up assessment
The data will be the biochemically confirmed reports of abstinence for the past 7 days (i.e., 7-day point-prevalence abstinence)
Measured 6 months after enrollment at follow-up assessment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Engagement in treatment
Time Frame: Measured 12 months after enrollment at follow-up assessment
The primary analyses will compare number of calls completed
Measured 12 months after enrollment at follow-up assessment
Cost-effectiveness
Time Frame: Measured 12 months after enrollment
The primary analysis will contrast the incremental costs of the treatment vs. attendance conditions by computing the Incremental Cost-Effectiveness Ratio (ICER) with regard to attaining 6-month abstinence.
Measured 12 months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Timothy B Baker, PhD, University of Wisconsin, Madison

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

March 30, 2012

First Submitted That Met QC Criteria

March 30, 2012

First Posted (Estimate)

April 3, 2012

Study Record Updates

Last Update Posted (Estimate)

December 6, 2016

Last Update Submitted That Met QC Criteria

December 5, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 2012-0198

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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