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Striving to Quit-Wisconsin Tobacco Quit Line

This study has been withdrawn prior to enrollment.
(Not able to recruit participants)
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01569477
First received: March 30, 2012
Last updated: March 7, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention
Smoking Cessation
Smoking
Nicotine Dependence
 Behavioral: Incentives for abstinence and treatment engagement
Behavioral: Attendance incentive

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Striving to Quit: Wisconsin Tobacco Quit Line Tobacco Cessation Research

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Abstinence from smoking [ Time Frame: Measured 6 months after enrollment at follow-up assessment ] [ Designated as safety issue: No ]
    The data will be the biochemically confirmed reports of abstinence for the past 7 days (i.e., 7-day point-prevalence abstinence)


Secondary Outcome Measures:
  • Engagement in treatment [ Time Frame: Measured 12 months after enrollment at follow-up assessment ] [ Designated as safety issue: No ]
    The primary analyses will compare number of calls completed

  • Cost-effectiveness [ Time Frame: Measured 12 months after enrollment ] [ Designated as safety issue: No ]
    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.


Enrollment: 0
Study Start Date: September 2012
Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment incentives
Incentives for biochemical verification visits, treatment engagement, and abstinence
 Behavioral: Incentives for abstinence and treatment engagement
Treatment incentives - incentives for biochemical verification visits, treatment engagement and abstinence
Active Comparator: Attendance incentive
Incentives for only attending the biochemical verification visits
 Behavioral: Attendance incentive
Attendance Incentives - incentives for only attending the biochemical verification visits

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01569477

Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Timothy B Baker, PhD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01569477     History of Changes
Other Study ID Numbers: 2012-0198
Study First Received: March 30, 2012
Last Updated: March 7, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Tobacco Use Disorder
Smoking
Substance-Related Disorders
Mental Disorders
Habits

ClinicalTrials.gov processed this record on May 21, 2013