Pregnancy Clinical Trial
Official title:
Tobacco Use in Pregnancy Intervention for Cessation
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.
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.
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