Striving to Quit: First Breath

University of Wisconsin, Madison3,100 enrolled

Overview

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 pregnant smokers.

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 prenatal and postnatal smoking abstinence. Participants will be BadgerCare Plus members who are recruited into the First Breath program while pregnant. Aim 2: To determine the extent to which treatment incentives, versus attendance incentives, increase rates of engagement in First Breath smoking cessation intervention when offered to pregnant and postpartum BadgerCare Plus members. Aim 3: To determine the cost-effectiveness and reach of the First Breath intervention delivered to pregnant and postpartum smokers when it is paired with treatment incentives and when paired with only attendance incentives. Aim 4: To determine if the First Breath intervention with treatment incentives, in comparison to that intervention with only attendance incentives, produces significantly greater benefits in pregnant and postpartum women with regards to nonsmoking health outcomes: i.e., reduced depression, increased levels of breast feeding, and greater perceived support. Aim 5: To identify moderating and mediating effects of treatment incentives when offered in the context of the First Breath intervention delivered to pregnant and postpartum women.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

3,100

Conditions

Smoking Cessation Smoking Nicotine Dependence

Interventions

Incentives for abstinence and treatment engagementBEHAVIORAL

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

Attendance incentiveBEHAVIORAL

Attendance Incentives - incentives for only attending the biochemical verification visits

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * pregnant women * enrollment in Wisconsin Medicaid (BadgerCare Plus or Medicaid SSI) * resides in study area * member of participating Medicaid HMOs * not involved in any other stop smoking research studies * 18 or older * English speaking * smoked daily (at least one cigarette each day for at least one week) at some time within the last 6 months * willingness to quit smoking, cut down, or stay quit * willing to complete study visits and phone calls * willing to provide updates in contact information Exclusion Criteria: * not enrolled in Wisconsin Medicaid (BadgerCare Plus or Medicaid SSI) * not enrolled in study area * not a member of participating Medicaid HMOs * not pregnant or enrolled in First Breath * less than 18 years of age * non-English speaking * does not smoke daily (at least one cigarette each day for at least one week) at least some time within the last 6 months * not willing to complete study procedures and assessments or provide updated contact information

Locations (1)

Wisconsin Women's Health Foundation

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

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)

Time frame: Measured 6 months after births at follow-up assessment

Secondary Outcomes

Engagement in treatment

The primary analyses will compare number of calls and visits completed.

Time frame: Measured 12 months after birth at follow-up assessment

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.

Time frame: Measured 12 months after birth

Data from ClinicalTrials.gov

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