Clinical trial NCT03442530: Tobacco Use in Pregnancy Intervention for Cessation
Official title: Tobacco Use in Pregnancy Intervention for Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: pregnancy, smoking cessation, tobacco, preterm birth, ToPIC
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: University of Kentucky
First posted: 2018-02-22
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* pregnant
* tobacco user
* able to read and write English
* Medicaid eligible

Exclusion Criteria:

* male

Primary outcomes:
measure: Smoking cessation
timeFrame: Baseline to third trimester
Secondary outcomes:
measure: Number of cigarettes per day
timeFrame: Baseline to third trimester
measure: Smoking cessation after delivery
timeFrame: Prior to delivery hospitalization discharge, estimated 3 days
measure: Infant birth weight
timeFrame: At time of delivery
measure: Gestational age
timeFrame: At time of delivery
measure: Health care utilization outside of well-visits
timeFrame: Birth to 6 months
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky College of Nursing
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Kristin Ashford
role: PRINCIPAL_INVESTIGATOR
References: