Provider and Patient RCT PROMOTE

Duke University

Status: Begins enrollment in 5 months

Conditions: Employment; Maternal Health; Pregnancy

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07108335

Pro00116081

1R01HD115609-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 404 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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404 participants in 4 patient groups

Receiving Patient Education

Experimental group

Description:

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

Treatment:

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

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

Usual Care

No Intervention group

Description:

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

Receiving Provider PROMOTE Training

Experimental group

Description:

Providers in this arm will receive training on PROMOTE

Treatment:

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

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

Usual Care of Provider

No Intervention group

Description:

Providers in this arm will continue usual care.