Provider and Patient RCT PROMOTE

NCT ID: NCT07108335

Last Updated: 2025-10-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 404 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-08-31
• Study Completion Date: 2029-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Receiving Patient Education

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

Group Type: EXPERIMENTAL

PROvider ReMote ObsTetric-Related Employment Education (PROMOTE)

Intervention Type: 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.

Usual Care

This arm has patients who receive care of a provider that was not trained on the PROMOTE curriculum.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Receiving Provider PROMOTE Training

Providers in this arm will receive training on PROMOTE

Group Type: EXPERIMENTAL

PROvider ReMote ObsTetric-Related Employment Education (PROMOTE)

Intervention Type: 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.

Usual Care of Provider

Providers in this arm will continue usual care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

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

• Not a clinical team member

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarahn Wheeler, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Central Contacts

Sarahn Wheeler, MD

Role: CONTACT

sarahn.wheeler@duke.edu

919-681-5220

Kristin Weaver

Role: CONTACT

kristin.weaver@duke.edu

Other Identifiers

1R01HD115609-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00116081

Identifier Type: -

Identifier Source: org_study_id