MOMs Chat & Care Study

December 15, 2025: A Year of Trial Results and Innovations From the NIH Pragmatic Trials Collaboratory

Posted on by Damon Seils

A collage of journal covers with the label "NIH Pragmatic Trials Collaboratory 2025 Publications Roundup"In 2025, NIH Pragmatic Trials Collaboratory investigators published new study designs and trial results, shared insights from program leadership, and developed innovative methods in the design, conduct, implementation, and dissemination of pragmatic clinical trials. Their work included perspectives from the Coordinating Center, best practices from the Core Working Groups, and results from the NIH Collaboratory Trials.

The program contributed 45 articles to the peer-reviewed literature this year, including the primary results of the ACP PEACE, BackInAction, HiLo, INSPIRE, and PRIM‑ER trials. Cross-Core and cross-Trial collaborations led to the sharing of important lessons from the conduct of multiple NIH Collaboratory Trials.

The total number of published articles from the program reached 386.

Coordinating Center

Cross-Core and Cross-Trial Collaborations

Distributed Research Network

Core Working Groups

Biostatistics and Study Design Core

Community Health Improvement Core

Electronic Health Records Core

Ethics and Regulatory Core

Health Care Systems Interactions Core

Patient-Centered Outcomes Core

NIH Collaboratory Trials

ABATE Infection

ACP PEACE

ARBOR-Telehealth

BackInAction

BeatPain Utah

BEST-ICU

EMBED

FM-TIPS

GGC4H

GRACE

HiLo

I CAN DO Surgical ACP

IMPACt-LBP

INSPIRE

iPATH

LIRE

MOMs Chat & Care Study

NOHARM

Nudge

OPTIMUM

PRIM-ER

SPOT

TAICHIKNEE

July 24, 2025: Recently Launched NIH Collaboratory Trials Offer Lessons for Embedded Pragmatic Research

Posted on by Karen Staman

At the NIH Pragmatic Trials Collaboratory’s 2025 Annual Steering Committee Meeting, Angelo Volandes, co–principal investigator (PI) of the ACP PEACE trial, led a panel of investigators who shared key challenges and lessons learned from their recently launched trials. The panelists included Stephanie Fitzpatrick, PI of the MOMs Chat & Care Study, Elizabeth Wick, co-PI of I CAN Do Surgical ACP, and ChenChen Wang and Robert Saper, co-PIs of TAICHIKNEE.

MOMs Chat & Care Study

Goal: To test the effectiveness of Northwell Health’s MOMs navigation program at 2 levels of intensity designed to facilitate timely, appropriate care for high-risk Black and Latina birthing people and reduce risk for severe maternal morbidity

Key Challenge: Low recruitment

Solutions:

  • Expanded inclusion criteria to include Hispanic/Latina patients, those with lower risk factor scores, and gestational of less than 17 weeks instead of less than 13 weeks
  • Added manual review of charts to ensure the patients they telephoned for recruitment are pregnant and to determine the number of weeks of pregnancy
  • Changed recruitment materials and general approach so that empathy is at the forefront

Learn more about the MOMs Chat & Care Study.

I CAN DO Surgical ACP

Goal: To identify a systems-based approach to help older adults undergoing major elective surgery engage in advance care planning decisions

Key Challenge: One site will finish 6 months early but will still have access to the platform for research, which provides an opportunity they do not want to waste

Solution: Use the trial infrastructure to pilot test another intervention in the remaining months of trial time. The plan is to develop and test human-in-the-loop patient-facing generative AI to assess the quality of patient–AI interactions and answer additional questions, potentially laying the groundwork for future trials.

Learn more about I CAN DO Surgical ACP.

TAICHIKNEE

Goal: To determine whether remotely delivered tai chi is feasible across the 4 partnering healthcare systems and if tai chi, compared with routine care, will improve physical health (including knee pain and function), mental health, and healthcare utilization

Key Challenge: Long delays at institutional review board due to backlogs

Solution: The PI understood that many organizations had to cut costs and reduce IRB and regulatory staff, which likely drove delays in regulatory approval. When the study leadership interacted with the IRB, they did so in a generous and curious way, asking how they could help. The regulatory staff acknowledged the problem and suggested that, as the trial is federally funded and meets the regulatory criteria to be considered minimal risk, it should take priority.

Learn more about TAICHIKNEE.

This summer, we are sharing highlights from the 2025 Annual Steering Committee Meeting. Access the complete collection of meeting materials.

March 11, 2025: Study Design Paper Published for MOMs Chat & Care Study

Posted on by Damon Seils

MOMs Chat and Care Study logoThe study design paper for the MOMs Chat & Care Study has been published online ahead of print in Contemporary Clinical Trials. Congratulations to the study team on reaching this important milestone for all NIH Collaboratory Trials!

The MOMs Chat and Care Study is testing the effectiveness of an integrated care model approach at 2 levels of intensity designed to facilitate timely, appropriate care for Black birthing people to reduce their risk for severe maternal morbidity. Patients in both study arms will receive close clinical and behavioral health monitoring and navigation to timely care and services.

The study is being led by Stephanie Fitzpatrick at the Feinstein Institutes for Medical Research and is supported by an R01 grant award from the National Institute of Nursing Research.

Read the full study design paper.

March 6, 2025: Enrollment Begins for Several of the Newest NIH Collaboratory Trials

Posted on by Damon Seils

In recent months, 5 of the newest NIH Collaboratory Trials have begun to enroll research participants. Congratulations to the study teams from ARBOR-Telehealth, BEST-ICU, Chat 4 Heart Health, I CAN DO Surgical ACP, and the MOMs Chat & Care Study for reaching this important project milestone!

 ARBOR-Telehealth is evaluating the use of a telehealth physical therapy strategy for patients who present to primary care clinics with low back pain in rural communities. The study is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases.

BEST-ICU is evaluating 2 strategies grounded in behavioral economics theory and implementation science to increase ABCDEF bundle adoption in the intensive care unit and improve care for critically ill adults across a variety of healthcare systems, particularly those serving populations with known health disparities. The ABCDEF bundle is a multicomponent, evidence-based intervention to improve team-based care. The trial is supported by the National, Heart, Lung, and Blood Institute (NHLBI).

Chat 4 Heart Health is testing the comparative effectiveness of 3 text messaging delivery strategies that have been shown to improve individuals’ self-management health behaviors, including physical activity and medication adherence. The study will provide evidence regarding the best population-based strategy for universal delivery to engage patients in self-management to improve the American Heart Association’s “Life’s Essential 8” measures for improving and maintaining cardiovascular health. The project is supported by NHLBI.

I CAN DO Surgical ACP is testing a system-based approach to help older adults undergoing elective surgery engage in advance care planning. Another goal of the study is to understand digital engagement, language, and social drivers of health that drive engagement in the intervention. The trial is supported by the National Institute on Aging.

The MOMs Chat and Care Study is testing the effectiveness of an integrated care model approach at 2 levels of intensity designed to facilitate timely, appropriate care for Black birthing people to reduce their risk for severe maternal morbidity. Patients in both study arms will receive close clinical and behavioral health monitoring and navigation to timely care and services. The study is supported by the National Institute of Nursing Research.

 

November 5, 2024: Study Snapshot and Updated Ethics Documentation Available for MOMs Chat & Care Study

Posted on by Damon Seils

MOMs Chat and Care Study logoA new study snapshot and updated ethics and regulatory documentation are now available for the MOMs Chat and Care Study. One year into the study, the research team reviewed and updated the minutes of their initial consultation with the Ethics and Regulatory Core.

The MOMs Chat and Care Study, an NIH Collaboratory Trial, is testing the effectiveness of an integrated care model approach at 2 levels of intensity designed to facilitate timely, appropriate care for Black birthing people to reduce their risk for severe maternal morbidity. Patients in both study arms will receive close clinical and behavioral health monitoring and navigation to timely care and services. The study is being led by Stephanie Fitzpatrick at the Feinstein Institutes for Medical Research and is supported by an R01 grant award from the National Institute of Nursing Research.

July 29, 2024: MOMs Chat & Care Study Aims to Address Crisis of Black Maternal Morbidity

Posted on by Damon Seils

Among the newest NIH Collaboratory Trials is a study of an intervention to reduce rates of severe maternal morbidity, a health crisis in the United States that disproportionately affects Black patients.

We spoke with principal investigator Stephanie Fitzpatrick about the MOMs Chat & Care Study at the NIH Collaboratory’s 2024 Annual Steering Committee Meeting.

“In the United States, we have the highest rate of maternal morbidity, particularly among Black birthing people,” Fitzpatrick explained. “With findings from our trial, we hope that we can train and support other health systems in being able to provide more intensive wraparound services to get Black birthing people the care they need when they need it to prevent complications and eventually death,” she added.

Fitzpatrick is a professor in the Institute of Health System Science in the Feinstein Institutes for Medical Research at Northwell Health.

The MOMs Chat & Care Study will test the effectiveness of an integrated care model approach at 2 levels of intensity designed to facilitate timely, appropriate care for Black birthing people to reduce their risk for severe maternal morbidity. This NIH Collaboratory Trial is supported by the National Institute of Nursing Research.

Learn more about the MOMs Chat & Care Study.

January 16, 2024: Ethics Consultation Documents Now Available for AIM-CP and MOMs Chat & Care Study

Posted on by Damon Seils

Ethics and regulatory onboarding documentation for 2 of the NIH Pragmatic Trials Collaboratory's newest trials is now available. The documents include meeting minutes and supplementary materials summarizing recent discussions of ethics and regulatory issues associated with the AIM-CP trial and the MOMs Chat & Care Study.

The consultations took place by video conference and included representation from the studies' principal investigators, members of the NIH Collaboratory's Ethics and Regulatory Core, NIH staff, and NIH Collaboratory Coordinating Center personnel.

AIM-CP will test a care management program to address inequities in access to nonpharmacological treatment for chronic pain in rural populations.

The MOMs Chat & Care Study will test the effectiveness of an integrated care model approach at 2 levels of intensity designed to facilitate timely, appropriate care for Black patients to reduce their risk for severe maternal morbidity.

Ethics and regulatory documentation for all of the NIH Collaboratory Trials is available on our Data and Resource Sharing page.

November 1, 2023 Virtual Onboarding Meeting: iPATH, AIM-CP, I CAN DO Surgical ACP, MOMS, RAMP, and ARBOR-Telehealth

NIH Pragmatic Trials Collaboratory Onboarding Meeting

November 1, 2023
Virtual

Purpose

Welcome the new UG3 and R01 NIH Collaboratory Trials; provide introductions and an overview of the NIH Collaboratory program; hear from the new UG3 and R01 project teams; and discuss lessons learned from the seasoned NIH Collaboratory Trial investigators.

Welcome and Opening Remarks
Wendy Weber, ND, PhD, MPH
Lesley Curtis, PhD

Overview of the NIH Pragmatic Trials Collaboratory and a Cooperative Agreement
Beda Jean-Francois, PhD

NIH Collaboratory Coordinating Center: Overview and Goals
Lesley Curtis, PhD

Program Policies and Guidance Documents
Rich Platt, MD, MSc
Gina Uhlenbrauck

Discussion of New NIH Collaboratory Trials

  • iPATH
    Sara Singer, PhD, MBA
  • AIM-CP
    Sebastian Tong, MD, MPH
    Kushang Patel, Phd, MPH
  • MOMs
    Stephanie Fitzpatrick, PhD
  • RAMP
    Diana Burgess, PhD
    Roni Evans, DC, MS, PhD
    Katherine Hadlandsmyth, PhD

Lessons Learned From Seasoned NIH Collaboratory Trials
Moderator: Lesley Curtis, PhD

Panel:

  • Lynn Debar, PhD
  • Angelo Volandes, MD, MPH
  • Susan Huang, MD, MPH
  • Michael Ho, MD, PhD
  • Kathleen Sluka, PT, PhD
  • Andrea Cheville, MD

Closing Remarks
Beda Jean-Francois, PhD
Lesley Curtis, PhD

October 31, 2023: NIH Pragmatic Trials Collaboratory Welcomes 5 New NIH Collaboratory Trials

Posted on by Lauren Stewart

The NIH Pragmatic Trials Collaboratory is excited to announce the addition of 5 new large-scale pragmatic clinical trials to its portfolio of innovative NIH Collaboratory Trials, which will extend the program's mission to strengthen the national capacity to implement cost-effective, large-scale research studies that engage healthcare delivery organizations as research partners.

Three of the new projects are funded through the Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) program, a component of the Helping to End Addiction Long-Term Initiative℠, or NIH HEAL Initiative℠, to address the opioid crisis.

  • Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth Intervention (RAMP) is a pragmatic trial that will address the challenge of implementing effective, non-opioid interventions for chronic pain management in rural and remote dwelling veteran populations by developing an innovative telehealth evidence-based intervention to address veterans' biophysical, psychological, and social needs. The study is administered by the National Institute of Nursing Research and will be conducted by Diana Burgess of the Minneapolis Veterans Affairs Healthcare System, Roni Evans of the University of Minnesota, and Katherine Hadlandsmyth of the University of Iowa.
  • Advancing Rural Back Pain Outcomes through Rehabilitation Telehealth (ARBOR-Telehealth) is a pragmatic trial that seeks to understand the effectiveness of telerehabilitation as a method of improving access to physical therapy for patients with chronic lower back pain living in rural communities and improving outcomes of these patients. The study is administered by the National Institute of Arthritis and Musculoskeletal and Skin Diseases and will be conducted by Richard Skolasky Jr and Kevin McLaughlin of Johns Hopkins University.
  • Adapting and Implementing a Nurse Care Management Model to Care for Rural Patients with Chronic Pain (AIM-CP) is a pragmatic trial that seeks to address chronic pain outcomes for individuals living in rural communities by adapting, piloting, and implementing a nurse care management model to test its effectiveness as a nonpharmacologic treatment option. The study is administered by the National Institute of Nursing Research and will be conducted by Sebastian Tong and Kushang Patel of the University of Washington.

The NIH Pragmatic Trials Collaboratory is also adding 2 projects supported by grants from the National Institute of Nursing Research and the National Institute on Minority Health and Health Disparities.

These new NIH Collaboratory Trials join the 4 other trials added to the NIH Pragmatic Trials Collaboratory portfolio in 2023, which include BEST-ICU, Chat 4 Heart Health, I CAN DO Surgical ACP, and TAICHIKNEE.