ClinicalTrials.gov
ClinicalTrials.gov Menu

Striving to Quit-Wisconsin Tobacco Quit Line

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01569477
Recruitment Status : Withdrawn (Not able to recruit participants)
First Posted : April 3, 2012
Last Update Posted : December 6, 2016
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
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 or disease Intervention/treatment Phase
Smoking Cessation Smoking Nicotine Dependence Behavioral: Incentives for abstinence and treatment engagement Behavioral: Attendance incentive Not Applicable

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  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Striving to Quit: Wisconsin Tobacco Quit Line Tobacco Cessation Research
Study Start Date : September 2012
Estimated Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Engagement in treatment [ Time Frame: Measured 12 months after enrollment at follow-up assessment ]
    The primary analyses will compare number of calls completed

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01569477


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

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01569477     History of Changes
Other Study ID Numbers: 2012-0198
First Posted: April 3, 2012    Key Record Dates
Last Update Posted: December 6, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders