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NCT Number: NCT07108335

Provider and Patient RCT PROMOTE

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.

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Key information

Conditions

Maternal Health Employment Pregnancy

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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.

  2. Number of participants who adhere to employer documentation recommendations

    Time frame: 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.

  3. Number of participants with undesired wage or advancement reduction

    Time frame: From enrollment to 12 weeks after birth of baby

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

  4. Number of participants with accommodation requests granted

    Time frame: From enrollment to 12 weeks after birth of baby

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

  5. Number of participants with improved maternal-infant health in pregnancy

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kristin Weaver

CONTACT

[email protected]

Sarahn Wheeler, MD

CONTACT

[email protected]

919-681-5220

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Aug 7, 2025
Registry last updated
Oct 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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