Building Equitable Linkages With Interprofessional Education Valuing Everyone

NCT06483022 | Terminated

• 1 other identifier: 24-1258
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum; Pain; Pregnancy Related

Keywords

Maternity Hospitals

Outcome Measures

Primary Outcomes (1)

• Severe Postpartum Pain

  Proportion of individuals with severe pain postpartum. Severe pain will be defined as pain score \>4 on postpartum day 1 following vaginal birth, or pain score \>7 on postpartum day 2 following cesarean birth, as documented in the electronic health record using the Numerical Rating Scale (NRS) of patient-reported pain from 0-10.

  0 to <24 and 24 to <48 hours postpartum

Secondary Outcomes (10)

• Birthing parent-reported experiences of the respectful care (Qualitative)

  2-8 weeks postpartum

• Patient-reported examples of respectful and equitable health care team member practices (Qualitative)

  2-8 weeks postpartum

• Patient-reported examples of supportive health team member practices for pain management (Qualitative)

  2-8 weeks postpartum

• Pain assessments

  0 to <24 and 24 to <48 hours postpartum

• NSAID doses administered

  0 to <24 and 24 to <48 hours postpartum

Study Arms (2)

Pre-intervention

PLACEBO COMPARATOR

In the pre-intervention sequence(s), birthing people at participating hospitals will experience treatment-as-usual.

Other: Usual Care

Post-intervention

ACTIVE COMPARATOR

In the post-intervention sequence(s), birthing people at participating hospitals will experience treatment by health care teams that have undergone the Building Equitable Linkages With Interprofessional Education Valuing Everyone interprofessional education (BELIEVE IPE) training.

Behavioral: BELIEVE IPE Training

Interventions

BELIEVE IPE Training BEHAVIORAL

The IPC training will be delivered to health team members who provide intrapartum and/or postpartum maternity care at each facility. Individuals with roles as maternity care providers, nurses, lactation consultants or doulas whose primary inpatient clinical assignment is maternity care will be included in the training. The training will consist of a pre-session module (about 60 minutes), a 90-minute interprofessional collaboration session, delivered using virtual reality head-sets, and post-session modules (about 60 minutes). The pre- and post-session modules will be delivered through an online learning platform.

Post-intervention

Usual Care OTHER

Prior to implementation of the IPC training, birthing people at the facilities will receive treatment-as-usual

Pre-intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• American Heart Association: collaborator

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alison Stuebe, MD, MSc

  University of North Carollina at Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: July 1, 2024
• Study Start: July 1, 2024
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: beginning 9 and continuing for 36 months following publication
• Access Criteria: Investigator has approved IRB, IEC or REB and an executed data use/sharing agreement with UNC and Cone Health.

Locations

US (1)