Pregnancy Clinical Trial
Official title:
Baby Steps III: Testing a Clinician and Patient Intervention to Promote Smoking Cessation Among Pregnant Women
The investigators propose to conduct a combined intervention that pairs SMS smoking cessation messages for patients with individualized training for OB clinicians to improve quit rates among pregnant smoking. The aim is to determine the effect of the intervention versus control on smoking cessation outcomes on patient smoking cessation. The investigators will recruit patients at their first OB visit who report smoking at Duke and Pitt. Patients in both the control and intervention arm will receive smoking cessation support messages throughout their pregnancy. OB clinicians in the intervention arm will receive tailored smoking cessation counseling training. Clinicians in both arms will receive a one-time 5 A lecture. The investigators will analyze smoking cessation outcomes and audio recordings. This is a minimal risk study.
Status | Recruiting |
Enrollment | 840 |
Est. completion date | June 1, 2025 |
Est. primary completion date | June 1, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - =18 years old - Receiving prenatal care from an enrolled OB clinician - Self-report smoking tobacco at their first OB visit - Access to a cell phone with texting capabilities Exclusion Criteria: - Unable to speak and read English |
Country | Name | City | State |
---|---|---|---|
United States | Durham OB | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University | University of Pittsburgh |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Patients in the Post-Intervention Phase With Validated Cessation | Biochemically validated (urine cotinine) 7-day point prevalent as defined by urine cotinine levels below 50ng/ML. | End-of-pregnancy, up to 45 minutes | |
Secondary | Number of A's performed in the Post-Intervention Phase for each Clinician | Obtained by coding 11 recordings of patient encounters in the Post-Intervention Phase. We will follow a codebook to assess the number of A's performed in the Post-Intervention visits for each clinician. Coders will also assess whether each Advice segment is clear, strong, or personalized. We will assign advice a score of 0-3 with a score of 3 indicating highest quality of advice. | Post-intervention recordings (all recording will happen prior to giving birth), up to 12 weeks | |
Secondary | Mean rated autonomy support for each Post-intervention patient | 6-item Health care climate questionnaire | Baseline, up to 15 minutes |
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