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Striving to Quit-Wisconsin Tobacco Quit Line

Primary Purpose

Smoking Cessation, Smoking, Nicotine Dependence

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Incentives for abstinence and treatment engagement

Attendance incentive

About this trial

This is an interventional treatment trial for Smoking Cessation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment incentives

Attendance incentive

Arm Description

Incentives for biochemical verification visits, treatment engagement, and abstinence

Incentives for only attending the biochemical verification visits

Outcomes

Primary Outcome Measures

Abstinence from smoking

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

The primary analyses will compare number of calls completed

Cost-effectiveness

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.

Full Information

NCT ID

NCT01569477

First Posted

March 30, 2012

Last Updated

December 5, 2016

Sponsor

University of Wisconsin, Madison

1. Study Identification

Unique Protocol Identification Number

NCT01569477

Brief Title

Striving to Quit-Wisconsin Tobacco Quit Line

Official Title

Striving to Quit: Wisconsin Tobacco Quit Line Tobacco Cessation Research

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Withdrawn

Why Stopped

Not able to recruit participants

Study Start Date

September 2012 (undefined)

Primary Completion Date

March 2013 (Anticipated)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Wisconsin, Madison

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Smoking Cessation, Smoking, Nicotine Dependence

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment incentives

Arm Type

Experimental

Arm Description

Incentives for biochemical verification visits, treatment engagement, and abstinence

Arm Title

Attendance incentive

Arm Type

Active Comparator

Arm Description

Incentives for only attending the biochemical verification visits

Intervention Type

Behavioral

Intervention Name(s)

Incentives for abstinence and treatment engagement

Intervention Description

Treatment incentives - incentives for biochemical verification visits, treatment engagement and abstinence

Intervention Type

Behavioral

Intervention Name(s)

Attendance incentive

Intervention Description

Attendance Incentives - incentives for only attending the biochemical verification visits

Primary Outcome Measure Information:

Title

Abstinence from smoking

Description

The data will be the biochemically confirmed reports of abstinence for the past 7 days (i.e., 7-day point-prevalence abstinence)

Time Frame

Measured 6 months after enrollment at follow-up assessment

Secondary Outcome Measure Information:

Title

Engagement in treatment

Description

The primary analyses will compare number of calls completed

Time Frame

Measured 12 months after enrollment at follow-up assessment

Title

Cost-effectiveness

Description

Time Frame

Measured 12 months after enrollment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Timothy B Baker, PhD

Organizational Affiliation

University of Wisconsin, Madison

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

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