Tobacco Use in Pregnancy Intervention for Cessation

Not Applicable

Completed

• Conditions: Pregnancy
• Interventions: Behavioral: ToPIC; Behavioral: Tobacco Treatment As Usual (TTAU)

• Registration Number: NCT03442530
• Lead Sponsor: Kristin Ashford

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.

Study Timeline

• Study Start: 2018-01-22
• Study First Submitted: 2018-01-30
• Study First Submitted QC: 2018-02-20
• Study First Posted: 2018-02-22
• Primary Completion: 2019-02-15
• Study Completion: 2019-02-15
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-23
• Last Update Posted: 2020-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 66

Inclusion Criteria

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

Exclusion Criteria

• male

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ToPIC	ToPIC	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.
Tobacco Treatment As Usual (TTAU)	Tobacco Treatment As Usual (TTAU)	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.

Primary Outcome Measures

Name	Time	Method
Smoking cessation	Baseline to third trimester	Change in urine cotinine level

Secondary Outcome Measures

Name	Time	Method
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
Health care utilization outside of well-visits	Birth to 6 months	Maternal and infant visits for non-routine healthcare
Number of cigarettes per day	Baseline to third trimester	Self-reported change in number of cigarettes smoked per day
Gestational age	At time of delivery	Weeks of gestation at delivery

Trial Locations

Locations (1)

University of Kentucky College of Nursing; 🇺🇸 Lexington, Kentucky, United States