Skip to content

Provider and Patient RCT PROMOTE

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07108335
Enrollment
404
Registered
2025-08-07
Start date
2026-10-01
Completion date
2029-08-01
Last updated
2026-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Employment, Maternal Health, Pregnancy

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.

Interventions

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.

Sponsors

Duke University
Lead SponsorOTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Frequency of EHR (electronic health record) documented work-related counselingFrom enrollment to 12 weeks after birth of childUsed to determine the effectiveness of PROMOTE vs. usual care to increase patients' receipt of counseling about workplace accommodations and pregnancy.
Number of participants who adhere to employer documentation recommendationsFrom enrollment to 12 weeks after birth of childUsed to determine the effectiveness of PROMOTE vs. usual care to increase patients' receipt of counseling about workplace accommodations and pregnancy.
Number of participants with undesired wage or advancement reductionFrom enrollment to 12 weeks after birth of babyDetermined by responses to surveys and qualitative interviews about work experiences.
Number of participants with accommodation requests grantedFrom enrollment to 12 weeks after birth of babyDetermined by responses to surveys and qualitative interviews about work experiences.
Number of participants with improved maternal-infant health in pregnancyFrom enrollment to 12 weeks after birth of babyDetermined by EHR-documented maternal infant health outcomes among patients receiving care by providers randomized to PROMOTE vs. usual care.

Contacts

CONTACTSarahn Wheeler, MD
sarahn.wheeler@duke.edu919-681-5220
CONTACTKristin Weaver
kristin.weaver@duke.edu
PRINCIPAL_INVESTIGATORSarahn Wheeler, MD

Duke University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 21, 2026