Provider and Patient RCT PROMOTE

NCT07108335 | Not Yet Recruiting

• 2 other identifiers: Pro001160811R01HD115609-01
• Study Type: interventional
• Target: 404
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Maternal Health; Pregnancy; Employment

Outcome Measures

Primary Outcomes (5)

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

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

  From enrollment to 12 weeks after birth of child

• Number of participants who adhere to employer documentation recommendations

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

  From enrollment to 12 weeks after birth of child

• Number of participants with undesired wage or advancement reduction

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

  From enrollment to 12 weeks after birth of baby

• Number of participants with accommodation requests granted

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

  From enrollment to 12 weeks after birth of baby

• Number of participants with improved maternal-infant health in pregnancy

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

  From enrollment to 12 weeks after birth of baby

Study Arms (4)

Receiving Patient Education

EXPERIMENTAL

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

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

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

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

Usual Care of Provider

NO INTERVENTION

Providers in this arm will continue usual care.

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.

Receiving Patient Education

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Non- English language fluency
• Unemployed with no desire to seek paid employment
• Not a clinical team member

Sponsors & Collaborators

• Duke University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Officials

• Sarahn Wheeler, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarahn Wheeler, MD

CONTACT

919-681-5220; sarahn.wheeler@duke.edu

Kristin Weaver

CONTACT

kristin.weaver@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 7, 2025
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2029
• Last Updated: October 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share