Provider and Patient RCT PROMOTE

Sponsor
Duke University
Study ID
NCT07108335
Status
Not Yet Recruiting

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Conditions

  • Employment
  • Maternal Health
  • Pregnancy

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • PROvider ReMote ObsTetric-Related Employment Education (PROMOTE) — OTHER
    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.
  • PROvider ReMote ObsTetric-Related Employment Education (PROMOTE) — OTHER
    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.

Study Details

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.

Key Dates

First listed
Aug 7, 2025
Start date
Aug 31, 2026
Status verified
Aug 2025
Primary completion
Aug 31, 2028
Completion
Aug 31, 2029

Study Design

Enrollment
404 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Receiving Patient Education
    This arm is provided with Patient Education from providers that have received training on PROMOTE.
  • No Intervention: Usual Care
    This arm has patients who receive care of a provider that was not trained on the PROMOTE curriculum.
  • Experimental: Receiving Provider PROMOTE Training
    Providers in this arm will receive training on PROMOTE
  • No Intervention: Usual Care of Provider
    Providers in this arm will continue usual care.

Primary Outcome Measure

Frequency of EHR (electronic health record) documented work-related counseling [ Time Frame: From enrollment to 12 weeks after birth of child ]

Central Contacts

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