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临床试验/NCT04985903
NCT04985903进行中(未招募)不适用

Baby Steps III: Testing a Clinician and Patient Intervention to Promote Smoking Cessation Among Pregnant Women

Duke University1 个研究点 分布在 1 个国家目标入组 840 人开始时间: 2022年3月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
840
试验地点
1
主要终点
Number of Patients in the Post-Intervention Phase With Validated Cessation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

盲法说明

We will mask the intervention arms during the coding process.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •≥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

排除标准

  • •Unable to speak and read English

研究组 & 干预措施

Control

Active Comparator

Clinicians in the control arm will be asked to attend a lecture on general information about smoking cessation for pregnant patients and smoking cessation counseling.

干预措施: 5A's lecture (Other)

Intervention

Experimental

Clinicians in the intervention arm will receive a tailored communication training on smoking cessation skills and a general lecture on smoking cessation.

干预措施: Clinician Communication Intervention (Behavioral)

Intervention

Experimental

Clinicians in the intervention arm will receive a tailored communication training on smoking cessation skills and a general lecture on smoking cessation.

干预措施: 5A's lecture (Other)

结局指标

主要结局

Number of Patients in the Post-Intervention Phase With Validated Cessation

时间窗: End-of-pregnancy, up to 45 minutes

Biochemically validated (urine cotinine) 7-day point prevalent as defined by urine cotinine levels below 50ng/ML.

次要结局

  • Mean rated autonomy support for each Post-intervention patient(Baseline, up to 15 minutes)
  • Number of A's performed in the Post-Intervention Phase for each Clinician(Post-intervention recordings (all recording will happen prior to giving birth), up to 12 weeks)

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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