Provider and Patient RCT PROMOTE
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PROvider ReMote ObsTetric-Related Employment Education (PROMOTE), PROvider ReMote ObsTetric-Related Employment Education (PROMOTE).
- Who it may be relevant to
- Registry conditions: Maternal Health, Pregnancy, Employment. Basic parameters: 18 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Provider Randomized Trial of the PROvider ReMote ObsTetric-Related Employment Education (PROMOTE)
Overview
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
- 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. - 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.
Primary outcome measures
- Frequency of EHR (electronic health record) documented work-related counseling [Time frame: From enrollment to 12 weeks after birth of child]
- Number of participants who adhere to employer documentation recommendations [Time frame: From enrollment to 12 weeks after birth of child]
- Number of participants with undesired wage or advancement reduction [Time frame: From enrollment to 12 weeks after birth of baby]
- Number of participants with accommodation requests granted [Time frame: From enrollment to 12 weeks after birth of baby]
- Number of participants with improved maternal-infant health in pregnancy [Time frame: From enrollment to 12 weeks after birth of baby]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07108335 · Pro00116081 · 1R01HD115609-01