Building Equitable Linkages With Interprofessional Education Valuing Everyone (BELIEVE)

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.

Study Overview

• Status: Terminated
• Conditions: Pain; Pregnancy Related; Postpartum
• Intervention / Treatment: Other: Usual Care; Behavioral: BELIEVE IPE Training

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Pre-intervention; In the pre-intervention sequence(s), birthing people at participating hospitals will experience treatment-as-usual.	Other: Usual Care; Prior to implementation of the IPC training, birthing people at the facilities will receive treatment-as-usual
Active Comparator: Post-intervention; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain assessments	Number of instances of pain score assessments on a 0-10 scale that are documented in the birthing parent's medical record.	0 to <24 and 24 to <48 hours postpartum
NSAID doses administered	Number of non-steroidal anti-inflammatory (NSAID) doses administered to the birthing parent, as documented in the medication administration record (MAR).	0 to <24 and 24 to <48 hours postpartum
MMEs administered	Number of Morphine Milligram Equivalents (MMEs) of opioids administered to the birthing parent, as documented in the medication administration record (MAR).	0 to <24 and 24 to <48 hours postpartum
Acetaminophen doses administered	Number of Acetaminophen doses administered to the birthing parent, as documented in the medication administration record (MAR).	0 to <24 and 24 to <48 hours postpartum
Healthcare team members' perceptions of interprofessional collaboration	Using the modified Interprofessional Attitudes Scale (IPAS), attitudes of health care team members toward collaboration will be assessed. The IPAS is a 5-point Likert scale with scores ranging from 27 to 135, with higher scores reflecting more positive attitudes toward interprofessional collaboration.	Baseline (pre-intervention) and after completing the IPC training intervention, a total of up to 4 months
Quality of interprofessional teamwork	Utilizing the modified Assessment for Collaborative Environments (ACE) Scale, health care team member perceptions of interprofessional communication will be assessed. The modified ACE is a 4-point Likert scale with scores ranging from 6 to 24, with higher scores reflecting better quality interprofessional teamwork.	Baseline (pre-intervention) and after completing the IPC training intervention, a total of up to 4 months
Feasibility of the IPC training	Based on semi-structured interviews collected post intervention among a subset of health care team members, the investigators will conduct thematic coded content analysis of transcribed responses. The investigators will report the count of health care team members who described the intervention as feasible. Feasibility is defined as a positive rating about the intervention's potential performance in real-life conditions in birthing hospitals.	2-8 weeks after health care team members' completion of the IPC training
Birthing parent-reported experiences of the respectful care (Qualitative)	Based on semi-structured interviews with a subset of birthing parents, the investigators will report the count of qualitative interview participants who described their care as "respectful" during semi-structured interviews with birthing parents.	2-8 weeks postpartum
Patient-reported examples of respectful and equitable health care team member practices (Qualitative)	Based on semi-structured interviews with a subset of birthing parents, the investigators will identify respectful and equitable health care team member practices in a thematic coded content analysis of transcribed responses. For the top three practices identified, the count of participants naming each practice will be reported.	2-8 weeks postpartum
Patient-reported examples of supportive health team member practices for pain management (Qualitative)	Based on semi-structured interviews with a subset of birthing parents, the investigators will identify supportive health team member practices for pain management in a thematic coded content analysis of transcribed responses. For the top three practices identified, the count of participants naming each practice will be reported.	2-8 weeks postpartum

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: American Heart Association
• Investigators: Principal Investigator: Alison Stuebe, MD, MSc, University of North Carollina at Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): February 28, 2025
• Study Completion (Actual): February 28, 2026

Study Registration Dates

• First Submitted: June 13, 2024
• First Submitted That Met QC Criteria: June 27, 2024
• First Posted (Actual): July 1, 2024

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Maternity Hospitals
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain
• Other Study ID Numbers: 24-1258

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC and Cone Health.
• IPD Sharing Time Frame: beginning 9 and continuing for 36 months following publication
• IPD Sharing Access Criteria: Investigator has approved IRB, IEC or REB and an executed data use/sharing agreement with UNC and Cone Health.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No