University of Kentucky College of Nursing
Lexington, Kentucky, 40536, United States
NCT Number: NCT03442530
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.
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Notify Me18 year–44 year
Female
Interventional
Not applicable
Lexington, Kentucky, 40536, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Expanded tobacco cessation counseling for pregnant women.
Standard of care tobacco cessation counseling for pregnant women
Time frame: Baseline to third trimester
Change in urine cotinine level
Time frame: Baseline to third trimester
Self-reported change in number of cigarettes smoked per day
Time frame: Prior to delivery hospitalization discharge, estimated 3 days
Self-report smoking cessation
Time frame: At time of delivery
Infant weight measured in grams
Time frame: At time of delivery
Weeks of gestation at delivery
Time frame: Birth to 6 months
Maternal and infant visits for non-routine healthcare
Kristin Ashford
Other
Acronym: ToPIC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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