BEST-ICU

January 8, 2026: Study Design Paper Published for BEST-ICU

Posted on by Damon Seils
Headshots of Dr. Michele Balas and Dr. Eduard Vasilevskis
Dr. Michele Balas and Dr. Eduard Vasilevskis, principal investigators for BEST-ICU

The study design paper for BEST-ICU has been published online in Trials. Congratulations to the study team on reaching this important milestone for all NIH Collaboratory Trials!

The BEST-ICU trial is evaluating 2 strategies grounded in behavioral economics theory and implementation science to increase adoption of the ABCDEF bundle in the intensive care unit and improve care for critically ill adults across a variety of healthcare systems. The ABCDEF bundle is a multicomponent, evidence-based intervention to improve team-based care.

The study is being led by Eduard Vasilevskis of the University of Wisconsin and Michele Balas of the University of Nebraska and is supported by a grant award from the National, Heart, Lung, and Blood Institute.

Read the full study design paper.

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

August 11, 2025: New Living Textbook Chapter Explores Implementation in Pragmatic Clinical Trials

Posted on by Karen Staman

The NIH Pragmatic Trials Collaboratory Implementation Science Core, led by Devon Check and Hayden Bosworth, has developed a new chapter on implementation to assist study teams with the complex process of using and studying implementation strategies to help implement research findings into clinical care. The chapter includes sections on:

Case studies are used to illustrate how pragmatic clinical trials embedded in healthcare systems use implementation frameworks, including examples from RAMP, BEST-ICU, STOP CRC, TSOS, ABATE, STEP-2, and GRACE.

For more, see our collection of chapters on Dissemination and Implementation, which includes chapters on Dissemination to Different Stakeholders, Data Sharing and Embedded Research, and End-of-Trial Decision-Making.

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.

 

February 26, 2025: BEST-ICU Trial to Be Featured in This Week’s PCT Grand Rounds

Posted on by Damon Seils

Headshots of Dr. Michele Balas and Dr. Eduard Vasilevskis
Dr. Michele Balas and Dr. Eduard Vasilevskis, principal investigators of BEST-ICU

In this Friday’s PCT Grand Rounds, Michele Balas and Ed Vasilevskis will present “Behavioral Economic and Staffing Strategies To Increase Adoption of the ABCDEF Bundle in the Intensive Care Unit (BEST-ICU): Protocol, Challenges, and Major Updates.”

The Grand Rounds session will be held on Friday, February 28, 2025, at 1:00 pm eastern.

BEST-ICU, an NIH Collaboratory Trial supported by the National Heart, Lung, and Blood Institute, 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. The ABCDEF bundle is a multicomponent, evidence-based intervention to improve team-based care. Learn more about BEST-ICU.

Balas is the Dorothy Hodges Olson Distinguished Professor of Nursing and the associate dean of research at the University of Nebraska Medical Center College of Nursing. Vasilevskis is a professor of medicine at the University of Wisconsin-Madison.

Join the online meeting.

October 21, 2024: BEST-ICU and Chat 4 Heart Health Have Updated Study Snapshots, Ethics and Regulatory Documentation

Posted on by Damon Seils

Updated study snapshots and ethics and regulatory documentation are now available for the BEST-ICU and Chat 4 Heart Health trials. Both of these NIH Collaboratory Trials are supported by awards from the National Heart, Lung, and Blood Institute.

BEST-ICU logoBEST-ICU transitioned from the planning phase to the implementation phase during the summer. As part of the transition, the study team reviewed and updated the minutes of their initial consultation with the Ethics and Regulatory Core. 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.

Chat 4 Heart Health logoChat 4 Heart Health also transitioned from planning to implementation this summer. The trial 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.

June 6, 2024: BEST-ICU Trial Transitions to Implementation Phase

Posted on by Elizabeth Mccamic

The NIH Pragmatic Trials Collaboratory Coordinating Center is pleased to announce that the BEST-ICU trial received approval to transition from the planning phase to the implementation phase of the study. Congratulations to the BEST-ICU principal investigators and study team for reaching this important milestone!

BEST-ICU, an NIH Collaboratory Trial, is a pragmatic trial that aims to develop pragmatic and sustainable strategies to increase the delivery of evidence-based practices that lead to improved care for critically ill adults across a variety of healthcare systems, particularly those serving populations with known health disparities. BEST-ICU will evaluate 2 strategies grounded in behavioral economy theory and implementation science to increase ABCDEF bundle adoption. The ABCDEF bundle is a multicomponent, evidence-based intervention to improve team-based care.

Principal investigators Ed Vasilevskis and Michele Balas spoke recently about the importance of the study at the NIH Pragmatic Trials Collaboratory’s 2024 Annual Steering Committee Meeting.

Vasilevskis is the chief of the Division of Hospital Medicine in the Department of Medicine at the University of Wisconsin School of Medicine and Public Health. Balas is the associate dean of research and the Dorothy Hodges Olson Distinguished Professor of Nursing at the University of Nebraska Medical Center's College of Nursing.

BEST-ICU is supported through a cooperative agreement from the National Heart, Lung, and Blood Institute.

Learn more about BEST-ICU.

October 10, 2023: Ethics Consultation Documents Now Available for BEST-ICU, Chat 4 Heart Health, and TAICHIKNEE

Posted on by Damon Seils

Ethics and regulatory onboarding documentation for the NIH Pragmatic Trials Collaboratory’s newest NIH Collaboratory Trials is now available. The documents include meeting minutes and supplementary materials summarizing recent discussions of ethics and regulatory issues associated with the BEST-ICU, Chat 4 Heart Health, and TAICHIKNEE studies.

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. All of the projects are in their 1-year planning phase.

BEST-ICU will explore the prevention of health impairments exacerbated by health disparities in the intensive care unit (ICU) through the application of the ABCDEF bundle, a multicomponent, evidence-based intervention to improve team-based care. The objective of the study is to evaluate 2 strategies grounded in behavioral economic theory and implementation science to increase ABCDEF bundle adoption and, in turn, address known health disparities in the ICU.

Chat 4 Heart Health will use a patient-level randomized pragmatic trial to test 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 findings will provide evidence regarding the best population-based strategy for universal delivery to engage all patients with health disparities in self-management to improve the American Heart Association’s “Life’s Essential 8” measures for improving and maintaining cardiovascular health.

TAICHIKNEE will compare the effects of web-based tai chi interventions versus routine care for individuals experiencing knee pain due to osteoarthritis. The practice of tai chi integrates physical, psychosocial, and behavioral components and has exhibited clinically significant improvements in chronic knee osteoarthritis pain conditions. The results of the study will inform widespread adoption of mind-body approaches for knee osteoarthritis, which affects more than 32.5 million individuals in the United States, across healthcare systems.

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

July 27, 2023: NIH Collaboratory Hosts Onboarding Session for Newest NIH Collaboratory Trials

Posted on by Damon Seils

Leaders of the NIH Pragmatic Trials Collaboratory hosted an onboarding meeting for the program's 3 newest NIH Collaboratory Trials. The projects joined the program under the UG3 cooperative agreement mechanism to support a 1-year planning phase in preparation for potential transition to a UH3 implementation phase.

Access the complete materials from the onboarding session.

During the session, NIH Collaboratory leaders provided an overview of the program, the cooperative agreement support mechanism, and the program's policies and guidance documents. The new NIH Collaboratory Trial investigators shared their aims for the UG3 planning phase. Finally, a panel of experienced NIH Collaboratory Trial investigators shared the lessons they learned from implementation of their studies.

The BEST-ICU NIH Collaboratory Trial will evaluate strategies grounded in behavioral economic theory and implementation science to increase adoption of the ABCDEF critical care bundle and address known health disparities in mechanical ventilation and symptom management practices in intensive care units. The project is supported by a cooperative agreement from the National Heart, Lung, and Blood Institute.

The Chat 4 Heart Health NIH Collaboratory Trial will test the comparative effectiveness of implementing text messaging delivery strategies that have been shown to improve an individual's self-management health behaviors, including physical activity and medication adherence. The project is supported by a cooperative agreement from the National Heart, Lung, and Blood Institute.

The TAICHIKNEE NIH Collaboratory Trial will compare the effects of web-based tai chi interventions vs routine care for persons experiencing knee pain due to osteoarthritis. The project is supported by a cooperative agreement from the National Center for Complementary and Integrative Health.

Learn more about the NIH Collaboratory Trials.

July 17, 2023 Virtual Onboarding Meeting: BEST-ICU, LE8 Bot + Backup, and TAICHIKNEE

NIH Pragmatic Trials Collaboratory Onboarding Meeting

July 17, 2023
Virtual

Purpose

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

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

Overview of the NIH Pragmatic Trials Collaboratory and a Cooperative Agreement
Wendy Weber, ND, PhD, MPH

NIH Collaboratory Coordinating Center: Overview and Goals
Adrian Hernandez, PhD

Program Policies and Guidance Documents
Adrian Hernandez, MD, MHS
Damon Seils, MA

Discussion of New UG3 NIH Collaboratory Trials

  • BEST-ICU
    Michele Balas, PhD, RN, CCRN-K, FCCM, FAAN
    Eduard Vasilevskis, MD, MPH
  • TAICHIKNEE
    Chenchen Wang, MD, MSc
    Eric Roseen, DC, MSc
    Robert Saper, MD
    Helen Lavertsky, MD, MS

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

Panel:

  • Miguel Vazquez, MD (ICD-Pieces)
  • Sheana Bull, PhD, MPH (Nudge)
  • Angelo Volandes, MD, MPH (ACP PEACE)
  • Stacy Sterling, DrPH, MSW (GGC4H)
  • Lynn DeBar, PhD (PPACT, BackInAction)
  • Julie Fritz, PhD, PT (BeatPain Utah)

Closing Remarks
Wendy Weber, ND, PhD, MPH
Lesley Curtis, PhD