Clinical trial NCT04985903: Baby Steps III: Testing a Clinician and Patient Intervention to Promote Smoking Cessation Among Pregnant Women
Official title: Baby Steps III: Testing a Clinician and Patient Intervention to Promote Smoking Cessation Among Pregnant Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking Cessation
Pregnancy
Communication Research
Keywords: Pregnant smokers
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
First posted: 2021-08-02
Enrollment: 840
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: The investigators propose a two-arm cluster randomized controlled design, in which the unit of randomization is the OB clinician. 70 OB clinicians will be randomly assigned to either the intervention or control condition. Although the unit of randomization is the clinician, the unit of evaluation is the patient: range of 6-13 patients per clinician (1-3 Pre-intervention and 5-10 Post-intervention) who receive prenatal care from enrolled OB clinicians at Duke and UPitt. The investigators will collect 3 Pre-Intervention audio-recorded initial OB visit encounters to assess pre-intervention levels of clinician communication skills and also to tailor the clinician training program. After the Pre-Intervention Phase, the investigators will randomize OB clinicians to either the intervention or control arm (see details of cluster randomization below). All OB clinicians will attend a lecture about the consequences of smoking during pregnancy and the elements of the 5 A's. Only OB clinicians randomized to the intervention arm will receive an individually-tailored, user-friendly, web-based program that teaches the 5 A's. In the Post-Intervention Phase, the investigators will assess the effect of the communication program by audio recording initial OB visits for between 5-10 pregnant women who smoke for each OB clinician in both arms (n=542 total). The investigators will provide all patients the SMS text-delivered intervention. Additionally, the investigators will survey these patients before their visit, immediately after their visit, at the end-of-pregnancy, and 6-weeks postpartum. Due to anticipated study attrition, the investigators will recruit up 80 clinicians and 700 patients at both sites until the investigators reach a complete data set for our desired sample size. Biochemically validated smoking cessation at end-of-pregnancy is the primary outcome (Aim 1). To assess Aim 2, investigators will code for clinician use of the 5 A's in the audio-recorded encounters and analyze patient perceptions of the communication from post-encounter data and the post-study survey for clinicians. To assess Aim 3, investigators will collect smoking status at 6 weeks postpartum.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients in the Post-Intervention Phase With Validated Cessation
timeFrame: End-of-pregnancy, up to 45 minutes
Secondary outcomes:
measure: Number of A's performed in the Post-Intervention Phase for each Clinician
timeFrame: Post-intervention recordings (all recording will happen prior to giving birth), up to 12 weeks
measure: Mean rated autonomy support for each Post-intervention patient
timeFrame: Baseline, up to 15 minutes
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham OB
state: North Carolina
Study officials:
affiliation: Duke University
name: Kathryn I Pollak, PhD
role: PRINCIPAL_INVESTIGATOR
References: