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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
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Smoking

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    February 16, 2016
    Last Updated
    April 18, 2017
    Sponsor
    University of Wisconsin, Madison
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    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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