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临床试验/NCT07108335
NCT07108335尚未招募不适用

Provider Randomized Trial of the PROvider ReMote ObsTetric-Related Employment Education (PROMOTE)

Duke University0 个研究点目标入组 404 人开始时间: 2026年10月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
404
主要终点
Number of participants with undesired wage or advancement reduction

研究概览

简要总结

Research Aim 1: Determine the effectiveness of PROMOTE vs. usual care to increase patients' receipt of counseling about workplace accommodations and pregnancy. Investigators will recruit and randomize Obstetric providers to the PROMOTE intervention or usual care. The investigators will compare the frequency of EHR documented work- related counseling and adherence to employer documentation recommendations between the two study arms.

Hypothesis: Patients receiving care by a provider randomized to PROMOTE will have higher rates of documented counseling about work and pregnancy.

Research Aim 2: Determine the effectiveness of PROMOTE vs. usual care to reduce undesired wage or advancement reduction, increase accommodation requests granted, and improve maternal-infant health. The investigators will recruit a racially and socioeconomically diverse cohort of 304 pregnant patients and compare responses to surveys and qualitative interviews about work experiences and EHR-documented maternal-infant health outcomes among patients receiving care by providers randomized to PROMOTE vs. usual care.

Hypothesis: Compared to patients receiving care by providers randomized to usual care, participants receiving care by providers randomized to PROMOTE will have less undesired loss of wages and advancement, increased accommodation request granted, and improved maternal-infant health during pregnancy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Participants:
  • Pregnant patients who are 24 - 32 weeks gestation
  • Employed or unemployed and seeking paid employment
  • Inclusion Criteria - Providers:
  • Clinical team member (doctor, nurse, advanced practice provider, any medical assistant or administrative staff)

排除标准

  • Participants:
  • Non- English language fluency
  • Unemployed with no desire to seek paid employment
  • Exclusion Criteria - Providers:
  • Not a clinical team member

研究组 & 干预措施

Receiving Patient Education

Experimental

This arm is provided with Patient Education from providers that have received training on PROMOTE.

干预措施: PROvider ReMote ObsTetric-Related Employment Education (PROMOTE) (Other)

Usual Care

No Intervention

This arm has patients who receive care of a provider that was not trained on the PROMOTE curriculum.

Receiving Provider PROMOTE Training

Experimental

Providers in this arm will receive training on PROMOTE

干预措施: PROvider ReMote ObsTetric-Related Employment Education (PROMOTE) (Other)

Usual Care of Provider

No Intervention

Providers in this arm will continue usual care.

结局指标

主要结局

Number of participants with undesired wage or advancement reduction

时间窗: From enrollment to 12 weeks after birth of baby

Determined by responses to surveys and qualitative interviews about work experiences.

Number of participants with accommodation requests granted

时间窗: From enrollment to 12 weeks after birth of baby

Determined by responses to surveys and qualitative interviews about work experiences.

Number of participants with improved maternal-infant health in pregnancy

时间窗: From enrollment to 12 weeks after birth of baby

Determined by EHR-documented maternal infant health outcomes among patients receiving care by providers randomized to PROMOTE vs. usual care.

Frequency of EHR (electronic health record) documented work-related counseling

时间窗: From enrollment to 12 weeks after birth of child

Used to determine the effectiveness of PROMOTE vs. usual care to increase patients' receipt of counseling about workplace accommodations and pregnancy.

Number of participants who adhere to employer documentation recommendations

时间窗: From enrollment to 12 weeks after birth of child

Used to determine the effectiveness of PROMOTE vs. usual care to increase patients' receipt of counseling about workplace accommodations and pregnancy.

次要结局

未报告次要终点

研究者

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

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