Provider and Patient RCT PROMOTE

Официальное название

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

Обзор

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.

Вмешательства

• Другое PROvider ReMote ObsTetric-Related Employment Education (PROMOTE)
  An on-demand 30-minute web-based training for clinical team members that provides a high-level summary of federal employment laws, work note templates embedded into the electronic health record (EHR) that prompt the clinician team member to include relevant information, and a patient-facing infographic designed to facilitate clinician counseling.
• Другое PROvider ReMote ObsTetric-Related Employment Education (PROMOTE)
  An on-demand 30-minute web-based training for clinical team members that provides a high-level summary of federal employment laws, work note templates embedded into the electronic health record (EHR) that prompt the clinician team member to include relevant information, and a patient-facing infographic designed to facilitate clinician counseling.

Первичные конечные точки

• Frequency of EHR (electronic health record) documented work-related counseling [Срок оценки: From enrollment to 12 weeks after birth of child]
• Number of participants who adhere to employer documentation recommendations [Срок оценки: From enrollment to 12 weeks after birth of child]
• Number of participants with undesired wage or advancement reduction [Срок оценки: From enrollment to 12 weeks after birth of baby]
• Number of participants with accommodation requests granted [Срок оценки: From enrollment to 12 weeks after birth of baby]
• Number of participants with improved maternal-infant health in pregnancy [Срок оценки: From enrollment to 12 weeks after birth of baby]

Критерии участия

Inclusion Criteria - 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)

Exclusion Criteria - Participants:

• Non- English language fluency
• Unemployed with no desire to seek paid employment

Exclusion Criteria - Providers:

• Not a clinical team member

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07108335 · Pro00116081 · 1R01HD115609-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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