NCT02713594

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,900

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2016

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 18, 2016

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
2 months until next milestone

Results Posted

Study results publicly available

April 21, 2017

Completed
Last Updated

April 21, 2017

Status Verified

April 1, 2017

Enrollment Period

2.9 years

First QC Date

February 16, 2016

Results QC Date

November 8, 2016

Last Update Submit

April 18, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Abstinence From Smoking

    The primary outcome data will be the biochemically confirmed abstinence using urine (measured cotinine) or exhaled (breath) carbon monoxide (CO).

    Measured 6 months after enrollment at follow-up assessment

Secondary Outcomes (2)

  • Engagement in Treatment

    Measured 6 months after enrollment at follow-up assessment

  • Cost-effectiveness

    Measured 6 months after enrollment

Study Arms (2)

Control

PLACEBO COMPARATOR

Counseling from WTQL

Behavioral: Counseling from WTQL

Incentive

EXPERIMENTAL

Counseling from WTQL; Financial incentive to participate

Behavioral: Counseling from WTQLOther: Financial incentive to participate

Interventions

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.

ControlIncentive

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.

Incentive

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • enrollment in Wisconsin Medicaid (BadgerCare Plus)
  • resides in study area (one of 25 counties)
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

SmokingSmoking CessationTobacco Use Disorder

Condition Hierarchy (Ancestors)

BehaviorHealth BehaviorSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Stevens S. Smith, Ph.D.
Organization
University of Wisconsin School of Medicine and Public Health

Study Officials

  • Timothy b Baker, PhD

    University of Wisconsin--CTRI

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2016

First Posted

March 18, 2016

Study Start

April 1, 2013

Primary Completion

March 1, 2016

Study Completion

March 1, 2017

Last Updated

April 21, 2017

Results First Posted

April 21, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share