Tobacco Use in Pregnancy Intervention for Cessation

Pregnancy Clinical Trial

— ToPIC  

Official title:

Tobacco Use in Pregnancy Intervention for Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03442530
• Other study ID #: 17-0658-P3K
• Status: Completed
• Phase: N/A
• Start date: January 22, 2018
• Est. completion date: February 15, 2019

Study information

• Verified date: March 2020
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: February 15, 2019
• Est. primary completion date: February 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

Inclusion Criteria:

• pregnant

• tobacco user

• able to read and write English

• Medicaid eligible

Exclusion Criteria:

• male

Related Conditions & MeSH terms

• Pregnancy

Intervention

Behavioral:
• ToPIC
Expanded tobacco cessation counseling for pregnant women.
• Tobacco Treatment As Usual (TTAU)
Standard of care tobacco cessation counseling for pregnant women

Locations

Country	Name	City	State
United States	University of Kentucky College of Nursing	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Kristin Ashford	University of Kentucky

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking cessation	Change in urine cotinine level	Baseline to third trimester
Secondary	Number of cigarettes per day	Self-reported change in number of cigarettes smoked per day	Baseline to third trimester
Secondary	Smoking cessation after delivery	Self-report smoking cessation	Prior to delivery hospitalization discharge, estimated 3 days
Secondary	Infant birth weight	Infant weight measured in grams	At time of delivery
Secondary	Gestational age	Weeks of gestation at delivery	At time of delivery
Secondary	Health care utilization outside of well-visits	Maternal and infant visits for non-routine healthcare	Birth to 6 months