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Tobacco Use in Pregnancy Intervention for Cessation (ToPIC)

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ClinicalTrials.gov Identifier: NCT03442530
Recruitment Status : Active, not recruiting
First Posted : February 22, 2018
Last Update Posted : March 19, 2019
Sponsor:
Collaborator:
University of Kentucky
Information provided by (Responsible Party):
Kristin Ashford, University of Kentucky

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.

Condition or disease Intervention/treatment Phase
Pregnancy Behavioral: ToPIC Behavioral: Tobacco Treatment As Usual (TTAU) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tobacco Use in Pregnancy Intervention for Cessation
Actual Study Start Date : January 22, 2018
Actual Primary Completion Date : February 15, 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Quitting Smoking

Arm Intervention/treatment
Active Comparator: 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.
Behavioral: Tobacco Treatment As Usual (TTAU)
Standard of care tobacco cessation counseling for pregnant women

Experimental: 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.
Behavioral: ToPIC
Expanded tobacco cessation counseling for pregnant women.




Primary Outcome Measures :
  1. Smoking cessation [ Time Frame: Baseline to third trimester ]
    Change in urine cotinine level


Secondary Outcome Measures :
  1. Number of cigarettes per day [ Time Frame: Baseline to third trimester ]
    Self-reported change in number of cigarettes smoked per day

  2. Smoking cessation after delivery [ Time Frame: Prior to delivery hospitalization discharge, estimated 3 days ]
    Self-report smoking cessation

  3. Infant birth weight [ Time Frame: At time of delivery ]
    Infant weight measured in grams

  4. Gestational age [ Time Frame: At time of delivery ]
    Weeks of gestation at delivery

  5. Health care utilization outside of well-visits [ Time Frame: Birth to 6 months ]
    Maternal and infant visits for non-routine healthcare



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   research participants must be pregnant
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • pregnant, tobacco user, read and write English, Medicaid eligible

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03442530


Locations
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United States, Kentucky
University of Kentucky College of Nursing
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
Kristin Ashford
University of Kentucky
Investigators
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Principal Investigator: Kristin Ashford University of Kentucky
  Study Documents (Full-Text)

Documents provided by Kristin Ashford, University of Kentucky:
Informed Consent Form  [PDF] September 14, 2018


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Responsible Party: Kristin Ashford, Associate Dean of Undergraduate Faculty Affairs, University of Kentucky College of Nursing, University of Kentucky
ClinicalTrials.gov Identifier: NCT03442530     History of Changes
Other Study ID Numbers: 17-0658-P3K
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kristin Ashford, University of Kentucky:
pregnancy, smoking cessation, tobacco, preterm birth, ToPIC