TAICHIKNEE

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.

April 15, 2024: TAICHIKNEE Randomizes First Cohort in Study to Improve Knee Osteoarthritis Pain

Posted on by Damon Seils

Logo for the TAICHIKNEE trialThe TAICHIKNEE study randomized its first cohort of participants this month, and the intervention group began tai chi classes this week. Congratulations to the TAICHIKNEE team for reaching this important milestone!

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. The results of the study will inform widespread adoption of mind-body approaches for knee osteoarthritis across healthcare systems.

TAICHIKNEE is supported within the NIH Pragmatic Trials Collaboratory through a cooperative agreement from the National Center for Complementary and Integrative Medicine. Learn more about TAICHIKNEE.

January 27, 2025: Study Snapshot and Updated Ethics Documentation Available for TAICHIKNEE

Posted on by Damon Seils

Logo for the TAICHIKNEE trialA new study snapshot and updated ethics and regulatory documentation are now available for the TAICHIKNEE trial. One year into the study, and after receiving approval to transition from the planning phase to the implementation phase, the research team reviewed and updated the minutes of their initial consultation with the Ethics and Regulatory Core.

New resources for TAICHIKNEE include:

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 across healthcare systems.

TAICHIKNEE is supported within the NIH Pragmatic Trials Collaboratory through a cooperative agreement from the National Center for Complementary and Integrative Medicine. Learn more about TAICHIKNEE.

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

July 6, 2023: NIH Pragmatic Trials Collaboratory Welcomes 2 New NIH Collaboratory Trials: BEST-ICU and TAICHIKNEE

Posted on by Lauren Stewart

Best-ICU Principal Investigators
From left: Dr. Michele Balas and Dr. Eduard Vasilevskis

The NIH Pragmatic Trials Collaboratory is excited to add 2 new NIH Collaboratory Trials to its portfolio of innovative pragmatic clinical trials embedded in healthcare systems. BEST-ICU (or Behavioral Economic and Staffing Strategies to Increase Adoption of the ABCDEF Bundle in the ICU) is supported by the National Heart, Lung, and Blood Institute (NHLBI). TAICHIKNEE (or Remote Tai Chi for Knee Osteoarthritis: An Embedded Pragmatic Trial) is supported by the National Center for Complementary and Integrative Health (NCCIH).

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 overall objective 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.

Drs. Michele Balas and Eduard Vasileviskis will serve as BEST-ICU's co–principal investigators. Dr. Balas is the associate dean of research and the Dorothy Hodges Olson Distinguished Professor of Nursing at the University of Nebraska Medical Center College of Nursing. Dr. Vasilevskis is a clinician-educator hospitalist and an associate professor of medicine in the Section of Hospital Medicine and the Division of General Internal Medicine and Public Health at Vanderbilt University Medical Center.

Headshots of Dr. Chenchen Wang, Dr. Helen Lavretsky, Dr. Eric Roseen, and Dr. Robert Saper
From left: Dr. Chenchen Wang, Dr. Helen Lavretsky, Dr. Eric Roseen, and Dr. Robert Saper

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 enable widespread adoption of mind-body approaches for knee osteoarthritis, which affects more than 32.5 million individuals in the United States, across healthcare systems.

TAICHIKNEE has 4 co–principal investigators. Dr. Chenchen Wang is a professor at Tufts University School of Medicine and the director of the Center for Complementary and Integrative Medicine in the Division of Rheumatology at Tufts Medical Center. Dr. Eric Roseen is an assistant professor of family medicine at Chobanian and Avedisian School of Medicine and a chiropractic physician at Joint Ventures Physical Therapy and Fitness. Dr. Robert Saper is the director of integrative medicine for the Boston Medical Center Department of Family Medicine and a professor in the Chobanian and Avedisian School of Medicine. Dr. Helen Lavretsky is a professor-in-residence in the Department of Psychiatry at UCLA and a geriatric integrative psychiatrist.

These 2 new NIH Collaboratory Trials supported within the NIH Collaboratory 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. To date, the NIH Collaboratory has supported 25 NIH Collaboratory Trials covering a range of clinical areas and spanning 12 NIH Institutes and Centers.