Tobacco Use in Pregnancy Intervention for Cessation

Study Overview
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Brief Summary
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The proposed project will test the effectiveness of the novel delivery of an established tobacco cessation treatment among pregnant women in Kentucky. Tobacco use during pregnancy is one of the most modifiable risk factors associated with poor birth and maternal outcomes and yet smoking prevalence among pregnant women in Kentucky is among the highest in the county and estimated to be twice that of the national average, with no meaningful declines observed in twenty years.

Detailed Description
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The purpose of this pilot project is to test effectiveness of a tobacco-treatment cessation intervention (American College of Obstetricians and Gynecologists (ACOG) 5 A's) through use of a non-physician healthcare champion from within the clinic's existing infrastructure. This Tobacco use in Pregnancy Intervention for Cessation (ToPIC) will involve training the identified healthcare provider to become a Certified Tobacco Treatment Specialist (CTTS) and to administer the 5 A's to pregnant Medicaid patients receiving prenatal care through two high-volume Kentucky obstetrics clinics. This trial will provide evidence to evaluate this approach to delivering an established intervention in clinical practice. The Investigators propose to test the effectiveness of the clinical intervention by using a two-armed cluster randomized controlled design. Eligible participants will be randomized to the intervention (ToPIC) or standard of care for smoking cessation in pregnancy. This pilot project will gather quantitative and qualitative data for a mixed-method, multi-stakeholder process evaluation of intervention training and delivery. Furthermore, the Investigators' use of Medicaid claims data to examine healthcare utilization outside of maternal and infant well-care visits will enhance understanding of the strengths and limitations of these data for future evaluations. This study has the potential to significantly impact the most vulnerable in Kentucky, where rates of tobacco use among pregnant women are among the highest in the nation.

Official Title
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Tobacco Use in Pregnancy Intervention for Cessation

Conditions
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Pregnancy

Intervention / Treatment
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* Behavioral: ToPIC
* Behavioral: Tobacco Treatment As Usual (TTAU)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pregnant tobacco user able to read and write English Medicaid eligible Exclusion Criteria: male

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tobacco Treatment As Usual (TTAU)<br>Eligible women assigned to the control group will be informed of the risks of tobacco use and benefits of quitting using the ACOG 5A's approach by their healthcare provider.5 This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The study coordinator will invite participants to complete the tobacco use questionnaires (TUQ),urine cotinine validation, and Expired Air Carbon Monoxide (EACO) analysis to assess ongoing tobacco use at the designated time points. | Behavioral: Tobacco Treatment As Usual (TTAU)<br>* Standard of care tobacco cessation counseling for pregnant women<br>|
| Experimental: ToPIC<br>Eligible women assigned to the intervention will receive TTAU plus ToPIC administered by the CTTS. At least once monthly, at routinely scheduled prenatal visits or through telephone, the CTTS will provide cessation counseling. The CTTS will invite participants to complete TUQs,urine cotinine validation and EACO analysis to assess ongoing tobacco use at the designated time points. | Behavioral: ToPIC<br>* Expanded tobacco cessation counseling for pregnant women.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking cessation | Change in urine cotinine level | Baseline to third trimester | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cigarettes per day | Self-reported change in number of cigarettes smoked per day | Baseline to third trimester | 
| Smoking cessation after delivery | Self-report smoking cessation | Prior to delivery hospitalization discharge, estimated 3 days | 
| Infant birth weight | Infant weight measured in grams | At time of delivery | 
| Gestational age | Weeks of gestation at delivery | At time of delivery | 
| Health care utilization outside of well-visits | Maternal and infant visits for non-routine healthcare | Birth to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregnancy, smoking cessation, tobacco, preterm birth, ToPIC