Pregnancy
Conditions
Keywords
pregnancy, smoking cessation, tobacco, preterm birth, ToPIC
Brief summary
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
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.
Interventions
BEHAVIORALToPIC
Expanded tobacco cessation counseling for pregnant women.
BEHAVIORALTobacco Treatment As Usual (TTAU)
Standard of care tobacco cessation counseling for pregnant women
Sponsors
University of Kentucky
Kristin Ashford
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
Yes
Inclusion criteria
* pregnant * tobacco user * able to read and write English * Medicaid eligible
Exclusion criteria
* male
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Smoking cessation | Baseline to third trimester | Change in urine cotinine level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of cigarettes per day | Baseline to third trimester | Self-reported change in number of cigarettes smoked per day |
| Smoking cessation after delivery | Prior to delivery hospitalization discharge, estimated 3 days | Self-report smoking cessation |
| Infant birth weight | At time of delivery | Infant weight measured in grams |
| Gestational age | At time of delivery | Weeks of gestation at delivery |
| Health care utilization outside of well-visits | Birth to 6 months | Maternal and infant visits for non-routine healthcare |
Countries
United States
Outcome results
None listed