Provider RCT PROMOTE

NCT07126405 | Withdrawn

• 2 other identifiers: Pro001184091R01HD115609-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Research Aim 1: Determine the effectiveness of PROMOTE vs. usual care to increase patients' receipt of counseling about workplace accommodations and pregnancy. We 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.

  Up to 1 year

• 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.

  Up to 1 year

• Number of participants with undesired wage or advancement reduction

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

  Up to 1 year

• Number of participants with accommodation requests granted

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

  Up to 1 year

• 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.

  Up to 1 year

Study Arms (2)

Receiving Provider PROMOTE Training

EXPERIMENTAL

Providers in this arm will receive training on PROMOTE

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

Usual Care

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 Provider PROMOTE Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical team member (doctor, nurse, advanced practice provider, any medical assistant or administrative staff)

You may not qualify if:

• Not a clinical team member

Sponsors & Collaborators

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

Study Sites (1)

Duke University

Durham, North Carolina, 27565, United States

Location

Study Officials

• Sarahn Wheeler, MD

  Duke University

  PRINCIPAL INVESTIGATOR

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 5, 2025
• First Posted: August 17, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: October 27, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)