Provider ConfidenceNCT07025057
Multilevel Community-Centered Intervention to Reduce Pregnancy Related and Associated Morbidity and Mortality (PRAMM) Disparities
A study testing Provider training in people with Provider Confidence and Provider Behavior, run by Michigan State University at 1 site in United States.
Trial summary
The goal of the study involving human subjects is to train providers to address patient-provider interactions. The study will survey providers to assess pre-post knowledge, understanding, and behavior changes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Provider Confidence, Provider Behavior
- What is being tested?
- Provider training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2025to 15 Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Providing care to pregnant and postpartum women in Wayne, Kent, and Genesee Counties in MI
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Strong Beginings
Grand Rapids, Michigan, 49503
Laurie Fitzpatrik, 2487161043, fitz125@msu.edu
About this study
Official title: Multilevel Community-centered Intervention to Reduce Pregnancy Related and Associated Morbidity and Mortality (PRAMM) Disparities in Non-Hispanic Black and Hispanic Medicaid-insured Individuals
The goal of the study involving human subjects is to train providers to address patient-provider interactions. The study will survey providers to assess pre-post knowledge, understanding, and behavior changes.
Read the detailed description
Provider/practice level intervention. The study will address patient-provider interactions through actionable, experiential provider trainings focused on communication provider, cultural relevance, and awareness of and referrals to community care services including CHWs and HV, for both clinical and community settings. Trainings are rooted in both history and in current research about how to address maternal mortality disparities, and will include self-learning, didactics, reflection, discussion, and identifying ways to tailor trainees settings to better hear, respect, and meet the needs of perinatal NHB/H women.
- Conditions
- Provider Confidence, Provider Behavior
- Being tested
- Provider training
- Keywords
- Maternal mortality, Maternal morbidity
- Medical subject headings
- Maternal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provider trainingBehavioural
The study will address patient-provider interactions through actionable, experiential provider trainings focused on communication provider, cultural relevance, and awareness of and referrals to community care services including Community Health Workers (CHW) and home visiting, for both clinical and community settings. Trainings are rooted in both history and in current research about how to address maternal mortality disparities, and will include self-learning, didactics, reflection, discussion, and identifying ways to tailor trainees settings to better hear, respect, and meet the needs of perinatal Black and Hispanic women.
| Study group | Role | What they receive |
|---|---|---|
| Provider training | Experimental | The providers in this arm will receive training Receives: Behavioral: Provider training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Provider confidence. Assessed through questionnaire.
Pre-post intervention change in provider confidence regarding provider-patient interactions
Measured: Assessment immediately after the provider training intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start3 Feb 2025
- Primary completion1 Aug 2029 (estimated)
- Study completion15 Aug 2030 (estimated)
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 Provider ConfidenceStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Cristian Meghea, Michigan State University
- Investigators
- Cristian Meghea, PhD, Principal investigator, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07025057
- Sponsor's protocol ID
- STUDY00009358
- Other IDs
- U54HD113291
- Status last verified
- Jul 2026
- First submitted
- 2 Jun 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study is collecting data and later will be sharing project-generated data according to NIH's requirements for depositing relevant de-identified data into appropriate NIH data archives.
Publications
Meghea CI, Bolder H, Yu X, Johnson JE, Wisdom K, Slaughter-Acey J, Vander Meulen P, Sanchez Lloyd C, Raffo JE, Nelson H, Meng R, Roman LA. Pragmatic trial of a multilevel community-centred intervention to reduce pregnancy-related and associated morbidity and mortality and disparities: a study protocol. BMJ Open. 2026 Sep 29;16(9):e126045. doi: 10.1136/bmjopen-2026-126045.
PubMed 42810787
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multilevel Community-centered Intervention to Reduce Pregnancy Related and Associated Morbidity and Mortality (PRAMM) Disparities in Non-Hispanic Black and Hispanic Medicaid-insured Individuals
- ClinicalTrials.gov ID
- NCT07025057
- Acronym / sponsor ID
- STUDY00009358
- Conditions
- Provider Confidence, Provider Behavior
- Keywords
- Maternal mortality, Maternal morbidity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 1 Aug 2029 (estimated)
- Study completion
- 15 Aug 2030 (estimated)
- First posted
- 17 Jun 2025 (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.
The goal of the study involving human subjects is to train providers to address patient-provider interactions. The study will survey providers to assess pre-post knowledge, understanding, and behavior changes.
Detailed description
Provider/practice level intervention. The study will address patient-provider interactions through actionable, experiential provider trainings focused on communication provider, cultural relevance, and awareness of and referrals to community care services including CHWs and HV, for both clinical and community settings. Trainings are rooted in both history and in current research about how to address maternal mortality disparities, and will include self-learning, didactics, reflection, discussion, and identifying ways to tailor trainees settings to better hear, respect, and meet the needs of perinatal NHB/H women.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Provider training | Experimental | Behavioral: Provider trainingThe providers in this arm will receive training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Providing care to pregnant and postpartum women in Wayne, Kent, and Genesee Counties in MI
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Provider trainingThe study will address patient-provider interactions through actionable, experiential provider trainings focused on communication provider, cultural relevance, and awareness of and referrals to community care services including Community Health Workers (CHW) and home visiting, for both clinical and community settings. Trainings are rooted in both history and in current research about how to address maternal mortality disparities, and will include self-learning, didactics, reflection, discussion, and identifying ways to tailor trainees settings to better hear, respect, and meet the needs of perinatal Black and Hispanic women. | Behavioural | Provider training |
Primary outcome
Provider confidence. Assessed through questionnaire.
Time frame: Assessment immediately after the provider training intervention
Pre-post intervention change in provider confidence regarding provider-patient interactions
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Derived from this study: PubMed 42810787Meghea CI, Bolder H, Yu X, Johnson JE, Wisdom K, Slaughter-Acey J, Vander Meulen P, Sanchez Lloyd C, Raffo JE, Nelson H, Meng R, Roman LA. Pragmatic trial of a multilevel community-centred intervention to reduce pregnancy-related and associated morbidity and mortality and disparities: a study protocol. BMJ Open. 2026 Sep 29;16(9):e126045. doi: 10.1136/bmjopen-2026-126045.
- Individual participant dataSharing planned: Yes. The study is collecting data and later will be sharing project-generated data according to NIH's requirements for depositing relevant de-identified data into appropriate NIH data archives.
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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.
Cristian Meghea, PhD principal investigator
Michigan State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provider training in people with Provider Confidence and Provider Behavior, run by Michigan State University 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 7 Jul 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Raffo, MA (12487161043, overfiel@msu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Provider confidence. Assessed through questionnaire. (time frame: Assessment immediately after the provider training intervention). 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 NCT07025057, 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 7 Jul 2026.