NCT01569477

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.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2012

Shorter than P25 for not_applicable

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 3, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

December 6, 2016

Status Verified

December 1, 2016

Enrollment Period

6 months

First QC Date

March 30, 2012

Last Update Submit

December 5, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

    Measured 6 months after enrollment at follow-up assessment

Secondary Outcomes (2)

  • Engagement in treatment

    Measured 12 months after enrollment at follow-up assessment

  • Cost-effectiveness

    Measured 12 months after enrollment

Study Arms (2)

Treatment incentives

EXPERIMENTAL

Incentives for biochemical verification visits, treatment engagement, and abstinence

Behavioral: Incentives for abstinence and treatment engagement

Attendance incentive

ACTIVE COMPARATOR

Incentives for only attending the biochemical verification visits

Behavioral: Attendance incentive

Interventions

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

Treatment incentives

Attendance Incentives - incentives for only attending the biochemical verification visits

Attendance incentive

Eligibility Criteria

Age18 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)
  • member of participating HMOs
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Smoking CessationSmokingTobacco Use Disorder

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Timothy B Baker, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2012

First Posted

April 3, 2012

Study Start

September 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

December 6, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will share