Provider and Patient RCT PROMOTE
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorDuke University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Non- English language fluency
Unemployed with no desire to seek paid employment
Not a clinical team member
Trial design
Design model
Parallel
Treatments tested in this trial
PROvider ReMote ObsTetric-Related Employment Education (PROMOTE)
Other interventionAn 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.
PROvider ReMote ObsTetric-Related Employment Education (PROMOTE)
Other interventionAn 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.
Treatment groups
404 Participants
are divided into 4 treatment groupsGroup A: Receiving Patient EducationExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions
Group C: Receiving Provider PROMOTE TrainingExperimental treatment 1 intervention
Group D: Usual Care of ProviderNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrollment to 12 weeks after birth of child2
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.
Time frame
From enrollment to 12 weeks after birth of child3
Number of participants with undesired wage or advancement reduction
Determined by responses to surveys and qualitative interviews about work experiences.
Time frame
From enrollment to 12 weeks after birth of baby4
Number of participants with accommodation requests granted
Determined by responses to surveys and qualitative interviews about work experiences.
Time frame
From enrollment to 12 weeks after birth of babyLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Duke University
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: