NCT07025057

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
480

participants targeted

Target at P75+ for not_applicable

Timeline
52mo left

Started Feb 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress23%
Feb 2025Aug 2030

Study Start

First participant enrolled

February 3, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 17, 2025

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2029

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2030

Last Updated

June 17, 2025

Status Verified

June 1, 2025

Enrollment Period

4.5 years

First QC Date

June 2, 2025

Last Update Submit

June 9, 2025

Conditions

Keywords

Maternal mortalityMaternal morbidity

Outcome Measures

Primary Outcomes (1)

  • Provider confidence. Assessed through questionnaire.

    Pre-post intervention change in provider confidence regarding provider-patient interactions

    Assessment immediately after the provider training intervention

Study Arms (1)

Provider training

EXPERIMENTAL

The providers in this arm will receive training

Behavioral: Provider training

Interventions

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.

Provider training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Providing care to pregnant and postpartum women in Wayne, Kent, and Genesee Counties in MI

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Strong Beginings

Grand Rapids, Michigan, 49503, United States

RECRUITING

MeSH Terms

Conditions

Maternal Death

Condition Hierarchy (Ancestors)

Parental DeathDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Cristian Meghea, PhD

    Michigan State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Raffo, MA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 2, 2025

First Posted

June 17, 2025

Study Start

February 3, 2025

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

August 15, 2030

Last Updated

June 17, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

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.

Locations