Striving to Quit: First Breath

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Striving to Quit: First Breath Tobacco Cessation Research

Conditions
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Smoking Cessation, Smoking, Nicotine Dependence

Intervention / Treatment
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* Behavioral: Incentives for abstinence and treatment engagement
* Behavioral: Attendance incentive


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment incentives<br>Incentives for biochemical verification visits, treatment engagement, and abstinence | Behavioral: Incentives for abstinence and treatment engagement<br>* Treatment Incentives - incentives for biochemical verification visits, treatment engagement, and abstinence<br>|
| Active Comparator: Attendance incentive<br>Incentives for only attending the biochemical verification visits | Behavioral: Attendance incentive<br>* Attendance Incentives - incentives for only attending the biochemical verification visits<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 births at follow-up assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Engagement in treatment | The primary analyses will compare number of calls and visits completed. | 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. | Measured 12 months after birth |