Pregnancy RelatedBELIEVENCT06483022
Building Equitable Linkages With Interprofessional Education Valuing Everyone
A study testing BELIEVE IPE Training in people with Pregnancy Related and Postpartum, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pregnancy Related, Postpartum, Pain
- What is being tested?
- BELIEVE IPE Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina
Chapel Hill, North Carolina, 27599
About this study
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
- Pregnancy Related, Postpartum, Pain
- Being tested
- BELIEVE IPE Training, Usual Care
- Keywords
- Maternity Hospitals
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BELIEVE IPE TrainingBehavioural
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.
Usual CareOther
Prior to implementation of the IPC training, birthing people at the facilities will receive treatment-as-usual
| Study group | Role | What they receive |
|---|---|---|
| Pre-intervention | Placebo comparator | In the pre-intervention sequence(s), birthing people at participating hospitals will experience treatment-as-usual. Receives: 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. Receives: Behavioral: BELIEVE IPE Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 to <24 and 24 to <48 hours postpartum
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 2-8 weeks postpartum
Pain assessments
Number of instances of pain score assessments on a 0-10 scale that are documented in the birthing parent's medical record.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2-8 weeks after health care team members' completion of the IPC training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start1 Jul 2024
- Primary completion28 Feb 2025
- Study completion28 Feb 2026
Why it stopped: The study has been terminated because because adequate recruitment of health team members for participation in the BELIEVE training at the study sites was not achieved.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Alison Stuebe, MD, MSc, Principal investigator, University of North Carollina at Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483022
- Sponsor's protocol ID
- 24-1258
- Acronym
- BELIEVE
- Status last verified
- Apr 2026
- First submitted
- 13 Jun 2024
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Oakcrum D, Ikejiaku P, McKinney JLG, Gibson AN, Jiang L, Lin FC, Tully KP, Williams JM, Harper K, Stuebe A. Building Equitable Linkages with Interprofessional Education Valuing Everyone (BELIEVE): research protocol for a multisite step-wedge cluster randomized trial. BMC Pregnancy Childbirth. 2026 May 22;26(1):794. doi: 10.1186/s12884-026-09195-x.
PubMed 42174469
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Equitable Linkages With Interprofessional Education Valuing Everyone
- ClinicalTrials.gov ID
- NCT06483022
- Acronym / sponsor ID
- BELIEVE / 24-1258
- Conditions
- Pregnancy Related, Postpartum, Pain
- Keywords
- Maternity Hospitals
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study has been terminated because because adequate recruitment of health team members for participation in the BELIEVE training at the study sites was not achieved.
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 1 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Pre-intervention | Placebo comparator | Other: Usual CareIn the pre-intervention sequence(s), birthing people at participating hospitals will experience treatment-as-usual. |
| Post-intervention | Active comparator | Behavioral: BELIEVE IPE TrainingIn 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- Healthcare Team Participants
- None
- Birthing Parent Data Extraction Participants
- Baby with birth gestational age < 24 weeks.
- Birthing Parent Interview Participants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BELIEVE IPE TrainingThe 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. | Behavioural | Post-intervention |
| Usual CarePrior to implementation of the IPC training, birthing people at the facilities will receive treatment-as-usual | Other | Pre-intervention |
Primary outcome
Severe Postpartum Pain
Time frame: 0 to <24 and 24 to <48 hours postpartum
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.
10 secondary outcomes
Birthing parent-reported experiences of the respectful care (Qualitative)
Time frame: 2-8 weeks postpartum
Patient-reported examples of respectful and equitable health care team member practices (Qualitative)
Time frame: 2-8 weeks postpartum
Patient-reported examples of supportive health team member practices for pain management (Qualitative)
Time frame: 2-8 weeks postpartum
Pain assessments
Time frame: 0 to <24 and 24 to <48 hours postpartum
NSAID doses administered
Time frame: 0 to <24 and 24 to <48 hours postpartum
MMEs administered
Time frame: 0 to <24 and 24 to <48 hours postpartum
Acetaminophen doses administered
Time frame: 0 to <24 and 24 to <48 hours postpartum
Healthcare team members' perceptions of interprofessional collaboration
Time frame: Baseline (pre-intervention) and after completing the IPC training intervention, a total of up to 4 months
Quality of interprofessional teamwork
Time frame: Baseline (pre-intervention) and after completing the IPC training intervention, a total of up to 4 months
Feasibility of the IPC training
Time frame: 2-8 weeks after health care team members' completion of the IPC training
Results and safety
The study was stopped early (reason given: The study has been terminated because because adequate recruitment of health team members for participation in the BELIEVE training at the study sites was not achieved.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Derived from this study: PubMed 42174469Oakcrum D, Ikejiaku P, McKinney JLG, Gibson AN, Jiang L, Lin FC, Tully KP, Williams JM, Harper K, Stuebe A. Building Equitable Linkages with Interprofessional Education Valuing Everyone (BELIEVE): research protocol for a multisite step-wedge cluster randomized trial. BMC Pregnancy Childbirth. 2026 May 22;26(1):794. doi: 10.1186/s12884-026-09195-x.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison Stuebe, MD, MSc principal investigator
University of North Carollina at Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BELIEVE IPE Training in people with Pregnancy Related and Postpartum, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study has been terminated because because adequate recruitment of health team members for participation in the BELIEVE training at the study sites was not achieved.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe Postpartum Pain (time frame: 0 to <24 and 24 to <48 hours postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06483022, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.