Clinical trial NCT06483022: Building Equitable Linkages With Interprofessional Education Valuing Everyone
Official title: Building Equitable Linkages With Interprofessional Education Valuing Everyone
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Pregnancy Related
Postpartum
Pain
Keywords: Maternity Hospitals
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2024-07-01
Enrollment: 32000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators plan a multisite step-wedge cluster randomized trial to test the extent to which interprofessional collaboration training (IPC training) reduces racial disparities in postpartum pain (primary outcome) and pain assessment and treatment (secondary, health team processes), improves birthing people's experience of respectful care (secondary outcomes), and fostering a positive shift in health team interprofessional collaboration attitudes and teamwork (secondary process outcomes).
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a step-wedge design implementation protocol of an interprofessional education curriculum intervention that is delivered through virtual reality and designed to reduce disparities and improve patient experiences in receiving maternal healthcare.


Eligibility criteria: Inclusion Criteria:

Healthcare Team Participants

* Employed as one of the following roles: maternity care provider, nurse, lactation consultant or doula.
* Primary inpatient clinical assignment is maternity care.
* If Per Diem: Employed for a minimum of 4 shifts/month at a participating site.

Birthing Parent Data Extraction Participants

• Had a live birth at a participating site from the start of the study through the last Data Retrieval timepoint.

Birthing Parent Interview Participants

* Had a live birth at a participating site from the start of the study through the last Data Retrieval timepoint.
* Black race or Limited English Proficiency with preferred language of Spanish.
* Age ≥ 18.

Exclusion Criteria:

Healthcare Team Participants

• None

Birthing Parent Data Extraction Participants

• Baby with birth gestational age \< 24 weeks.

Birthing Parent Interview Participants

* Baby with birth gestational age \< 24 weeks.
* Baby is no longer alive at time of Data Retrieval (regardless of gestational age).
* Currently incarcerated.
* Previously completed a birthing parent interview for the BELIEVE study.
* Previously enrolled as a Healthcare Team Participant.

Primary outcomes:
measure: Severe Postpartum Pain
timeFrame: 0 to <24 and 24 to <48 hours postpartum
Secondary outcomes:
measure: Birthing parent-reported experiences of the respectful care (Qualitative)
timeFrame: 2-8 weeks postpartum
measure: Patient-reported examples of respectful and equitable health care team member practices (Qualitative)
timeFrame: 2-8 weeks postpartum
measure: Patient-reported examples of supportive health team member practices for pain management (Qualitative)
timeFrame: 2-8 weeks postpartum
measure: Pain assessments
timeFrame: 0 to <24 and 24 to <48 hours postpartum
measure: NSAID doses administered
timeFrame: 0 to <24 and 24 to <48 hours postpartum
measure: MMEs administered
timeFrame: 0 to <24 and 24 to <48 hours postpartum
measure: Acetaminophen doses administered
timeFrame: 0 to <24 and 24 to <48 hours postpartum
measure: Healthcare team members' perceptions of interprofessional collaboration
timeFrame: Baseline (pre-intervention) and after completing the IPC training intervention, a total of up to 4 months
measure: Quality of interprofessional teamwork
timeFrame: Baseline (pre-intervention) and after completing the IPC training intervention, a total of up to 4 months
measure: Feasibility of the IPC training
timeFrame: 2-8 weeks after health care team members' completion of the IPC training
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: University of North Carollina at Chapel Hill
name: Alison Stuebe, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: