MedPath

MOMs Chat and Care Study Updates Ethics Documentation and Releases Study Snapshot

• The MOMs Chat and Care Study, an NIH Collaboratory Trial, has updated its ethics and regulatory documentation after one year of research. • This study is evaluating an integrated care model to improve outcomes for Black birthing people and reduce severe maternal morbidity. • The trial involves close clinical and behavioral health monitoring, along with navigation to timely care and services for participants. • Led by Stephanie Fitzpatrick at the Feinstein Institutes for Medical Research, the study is funded by an R01 grant from the National Institute of Nursing Research.

The MOMs Chat and Care Study, a significant NIH Collaboratory Trial, has released an updated study snapshot and revised ethics and regulatory documentation following its first year. This trial is designed to assess the effectiveness of an integrated care model in mitigating the risk of severe maternal morbidity among Black birthing individuals.

Integrated Care Model

The MOMs Chat and Care Study employs a two-tiered approach to integrated care, aiming to provide timely and appropriate interventions. Participants in both study arms benefit from rigorous clinical and behavioral health monitoring, coupled with facilitated access to essential care and services. This comprehensive strategy is intended to address the multifaceted challenges contributing to maternal health disparities.

Leadership and Funding

Stephanie Fitzpatrick, at the Feinstein Institutes for Medical Research, spearheads the MOMs Chat and Care Study. The project receives substantial financial support through an R01 grant from the National Institute of Nursing Research, underscoring the NIH's commitment to addressing critical gaps in maternal healthcare.

Goal of the Study

The primary goal of the MOMs Chat and Care Study is to reduce the disproportionately high rates of severe maternal morbidity experienced by Black birthing people. By implementing and evaluating an integrated care model, the study seeks to identify effective strategies for improving maternal health outcomes and reducing disparities in healthcare access and quality.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

Finalized Diversity in Clinical Trials Guidance and Revised Short Form Consent Policy Implemented

The University of Washington has announced the finalization of the Diversity in Clinical Trials Guidance and the implementation of a Revised Short Form Consent Policy, effective from January 1, 2026. These changes aim to improve participation from underrepresented communities in clinical trials and streamline the consent process for non-English speaking participants.

FDA Roundup: January 7, 2025

The FDA has issued several guidances aimed at improving clinical trials and reducing dietary exposure to contaminants. Key updates include draft guidances on evaluating sex-specific and gender-specific data in medical device studies, developing drugs for optical imaging, and considerations for tissue biopsies in clinical trials. Additionally, a final guidance on action levels for lead in processed food for babies and young children was released, supporting the Closer to Zero initiative.

I CAN DO Surgical ACP Trial Updates Ethics Documentation for Implementation Phase

The I CAN DO Surgical ACP trial has updated its ethics and regulatory documentation as it transitions to the implementation phase.
This NIH Collaboratory Trial is evaluating a system-based approach to promote advance care planning among older adults undergoing elective surgery.

NIH Collaboratory Trials BEST-ICU and Chat 4 Heart Health Transition to Implementation Phase

The BEST-ICU trial, supported by the National Heart, Lung, and Blood Institute, is now in the implementation phase, focusing on improving care for critically ill adults by increasing ABCDEF bundle adoption.
BEST-ICU is employing behavioral economics strategies to enhance the adoption of the ABCDEF bundle in intensive care units, particularly in healthcare systems serving populations with health disparities.

Multisite Study Aims to Improve ABCDEF Bundle Implementation in ICUs

A multisite study led by UNMC is assessing strategies to improve the implementation of the ABCDEF Bundle in ICUs, a standard of care for critically ill patients.
The five-year study, funded by the NIH, involves mechanically ventilated ICU patients across multiple hospitals and will compare different implementation methods.

FM-TIPS Trial Reassesses Sample Size for Fibromyalgia Pain Study

The FM-TIPS trial, an NIH Collaboratory study, is reassessing its sample size mid-study to account for intraclass correlation in cluster randomized trials.
Researchers are using interim data to refine sample size, addressing the challenge of unavailable preliminary data at the study's outset.

NIDDK Launches Longitudinal Study to Track Early Childhood Health Determinants in Arizona

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has initiated the ETCHED study to follow 750 mother-child pairs from pregnancy through the child's 18th birthday.
The primary goal is to investigate how maternal risk factors like pre-pregnancy BMI, gestational weight gain, and glycemia impact offspring birth weight and adiposity during infancy.

NIH HEAL Initiative Funds Pragmatic Trials for Non-Opioid Pain Management

The NIH HEAL Initiative is funding pragmatic clinical trials focused on non-opioid pain management within the NIH-DOD-VA Pain Management Collaboratory.
The trials will study non-opioid approaches, including complementary and integrative methods, for managing pain and comorbid conditions in veterans and military personnel.

NIH Funds $15.5 Million Network to Boost Clinical Trial Participation Among Nursing Home Residents

The NIH has granted $15.5 million to establish NEXT STEPs, a national network aimed at including more nursing home residents in clinical research.
NEXT STEPs will focus on prevention, therapeutics, and care interventions to improve the quality of life for individuals in nursing homes.

NIH Grant Supports Development of Patient-Specific Breast Reconstruction Molds

A multi-institutional research team secured a $2.7 million NIH grant to develop patient-specific molds for breast reconstruction after mastectomy, aiming to improve efficiency and psychosocial outcomes.
The project will create clinical decision-support algorithms for designing these molds, potentially reducing the number of revision surgeries needed and associated costs.

Reference News

[1]
November 5, 2024: Study Snapshot and Updated Ethics Documentation Available for MOMs ...
rethinkingclinicaltrials.org · Nov 5, 2024

New study snapshot and updated ethics/regulatory docs available for MOMs Chat and Care Study, testing integrated care mo...

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy