Wisconsin Tobacco Quit Line Medicaid Incentive Evaluation
Primary Purpose
Smoking, Smoking Cessation, Nicotine Dependence
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Counseling from WTQL
Financial incentive to participate
Sponsored by
About this trial
This is an interventional health services research trial for Smoking
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control
Incentive
Arm Description
Counseling from WTQL
Counseling from WTQL; Financial incentive to participate
Outcomes
Primary Outcome Measures
Abstinence From Smoking
The primary outcome data will be the biochemically confirmed abstinence using urine (measured cotinine) or exhaled (breath) carbon monoxide (CO).
Secondary Outcome Measures
Engagement in Treatment
This analysis will compare number of calls completed
Cost-effectiveness
This analysis will quantify the costs of treatment for Control and Incentive conditions with regard to attaining 6-month abstinence. Project costs were allocated to three categories: 1) Service costs, including billed staff time for counseling and testing, as well as all incidentals connected with services; 2) Incentives and distribution costs; and 3) Service-related administrative costs, including promotion/marketing and staff time for administering the intervention. Costs of planning the project, grant administration, and research within the project are not included in the analysis.The outcome is the cost per quit in each treatment group. Cost per quit in each group was calculated by: 1) computing the grand total of costs for all participants in a given group; and 2) dividing the grand total for a given group by the number of successful quitters. As such, the cost per quit is a single value with no measure of dispersion.
Full Information
NCT ID
NCT02713594
First Posted
February 16, 2016
Last Updated
April 18, 2017
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT02713594
Brief Title
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
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Smoking Cessation, Nicotine Dependence
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1900 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Counseling from WTQL
Arm Title
Incentive
Arm Type
Experimental
Arm Description
Counseling from WTQL; Financial incentive to participate
Intervention Type
Behavioral
Intervention Name(s)
Counseling from WTQL
Intervention Description
Counseling from the Wisconsin Tobacco Quit Line (WTQL) consisted of 5 proactive calls to the participant to help them successfully quit tobacco use, plus ad hoc calls at the participant's initiation; also, WTQL coaches encouraged participants to see their health care provider to obtain Medicaid-approved smoking cessation medications to help them quit smoking.
Intervention Type
Other
Intervention Name(s)
Financial incentive to participate
Intervention Description
Participants in the Incentive condition received $30 per call for up to five WTQL calls taken; in addition, Incentive condition participants received $40 for producing biochemical evidence of abstinence at the 6-month follow-up visit. (Note that participants in both the Control condition and the Incentive condition received $40 for completing the baseline biochemical smoking status assessment visit and $40 for completing the 6-month follow-up biochemical smoking status assessment visit.) Compensation was in the form of prepaid Visa gift cards mailed approximately 2-4 weeks after the point of contact.
Primary Outcome Measure Information:
Title
Abstinence From Smoking
Description
The primary outcome data will be the biochemically confirmed abstinence using urine (measured cotinine) or exhaled (breath) carbon monoxide (CO).
Time Frame
Measured 6 months after enrollment at follow-up assessment
Secondary Outcome Measure Information:
Title
Engagement in Treatment
Description
This analysis will compare number of calls completed
Time Frame
Measured 6 months after enrollment at follow-up assessment
Title
Cost-effectiveness
Description
This analysis will quantify the costs of treatment for Control and Incentive conditions with regard to attaining 6-month abstinence. Project costs were allocated to three categories: 1) Service costs, including billed staff time for counseling and testing, as well as all incidentals connected with services; 2) Incentives and distribution costs; and 3) Service-related administrative costs, including promotion/marketing and staff time for administering the intervention. Costs of planning the project, grant administration, and research within the project are not included in the analysis.The outcome is the cost per quit in each treatment group. Cost per quit in each group was calculated by: 1) computing the grand total of costs for all participants in a given group; and 2) dividing the grand total for a given group by the number of successful quitters. As such, the cost per quit is a single value with no measure of dispersion.
Time Frame
Measured 6 months after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy b Baker, PhD
Organizational Affiliation
University of Wisconsin--CTRI
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29079405
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.
Results Reference
derived
Learn more about this trial
Wisconsin Tobacco Quit Line Medicaid Incentive Evaluation
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