January 26, 2026: New Findings From GRACE Trial Highlight Strategies for Integrating Acupuncture and Guided Relaxation Into Sickle Cell Disease Clinics

GRACE Trial logoNew qualitative findings from the GRACE trial reveal critical barriers and facilitators for incorporating complementary and integrative health interventions into routine clinical care. The study emphasizes that successful integration requires participatory approaches and significant adjustments to clinic workflows.

The article was published online ahead of print in Pain Management Nursing.

GRACE, an NIH Collaboratory Trial, is a pragmatic clinical trial embedded in 3 large healthcare systems to assess the effectiveness of guided relaxation and acupuncture treatments to improve pain control for patients with sickle cell disease. While clinical guidelines promote nonpharmacological treatments to reduce reliance on opioids, integrating therapies like acupuncture and guided relaxation into standard practice remains challenging.

The researchers conducted in-depth interviews with 13 hematologists, nurses, and pharmacists at GRACE trial sites. Two primary themes emerged: the variable impact on clinic operations, and the requirements for introducing complementary and integrative health interventions into clinical practice.

Participants noted that even minor changes can disrupt complex clinic workflows. Specifically, they identified the need for flexible or extended clinic hours to accommodate multiweek courses of acupuncture, as well as space for administering treatments without interrupting other patient visits. Participants also noted that clinics would benefit from streamlined ordering processes to avoid administrative burdens.

The study highlighted a significant need for patient and clinician education. While evidence exists for complementary and integrative health interventions, many clinicians remain hesitant to recommend them due to knowledge gaps. Patients may also feel wary of new therapies, necessitating clear, accessible educational tools like videos, apps, and brochures.

GRACE is supported within the NIH Pragmatic Trials Collaboratory through the NIH HEAL Initiative by a grant from the National Center for Complementary and Integrative Health. Learn more about GRACE.

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

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

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.

December 12, 2024: A Year of Innovations and Insights From the NIH Pragmatic Trials Collaboratory

A graphic showing a collection of journal covers.In 2024, experts from the NIH Pragmatic Trials Collaboratory published the results of newly completed studies, shared insights from program leadership, and developed innovative methods in the design, conduct, and analysis 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 more than 30 articles to the peer-reviewed literature this year, including the primary results of the ICD-Pieces and Nudge trials. Several 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 surpassed 340.

Coordinating Center

Cross-Core and Cross-Trial Collaborations

Core Working Groups

Biostatistics and Study Design Core

Electronic Health Records Core

Ethics and Regulatory Core

Community Health Improvement Core

Implementation Science Core

Patient-Centered Outcomes Core

NIH Collaboratory Trials

ABATE Infection

BackInAction

BeatPain Utah

EMBED

FM-TIPS

GGC4H

GRACE

I CAN DO Surgical ACP

ICD-Pieces

LIRE

NOHARM

Nudge

OPTIMUM

PRIM-ER

PROVEN

SPOT

STOP CRC

TSOS

September 24, 2024: GRACE Team Identifies Barriers to Integrating Acupuncture Into US Healthcare System

Cover of the Journal of Integrative and Complementary Medicine (JICM)In a systematic review of the literature, researchers from the GRACE trial identified and categorized barriers and facilitators related to integrating acupuncture into the US healthcare system.

The review was published online ahead of print in the Journal of Integrative and Complementary Medicine.

Acupuncture is widely practiced in the United States and has been shown to be effective in multiple clinical applications for a variety of conditions. Yet, its integration into the healthcare system has been uneven.

In their review of the existing evidence, the authors found:

  • Understanding and addressing individual patients’ needs, awareness, concerns, and financial constraints is essential
  • Healthcare providers play an important role in communicating information about acupuncture to their patients and building trust
  • Organization-level changes are needed to address lack of space in healthcare facilities, lack of referral systems, and lack of credentialing and privileging procedures
  • Policies related to payment by both private and public insurers have been slow to change

Read the full report.

The authors stress that studies testing implementation of acupuncture interventions in real-world settings can help to address barriers to integration.

“Results of this study can be used to optimize strategies to effectively implement acupuncture into clinical practice, and ultimately influence policy changes,” they wrote.

GRACE, an NIH Collaboratory Trial, is a pragmatic clinical trial testing real-world implementation of acupuncture and guided relaxation for patients with pain associated with sickle cell disease. The trial is supported within the NIH Pragmatic Trials Collaboratory through the NIH HEAL Initiative under an award administered by the National Center for Complementary and Integrative Health. Learn more about the GRACE trial.

October 12, 2023: GRACE Team Shares Lessons About Monitoring Signals of Suicidality in Pragmatic Clinical Trials

In a new article published this week in Contemporary Clinical Trials Communications, the GRACE DNIH Collaboratory Trial team recommends that suicidality should be monitored in pragmatic clinical trials that measure depression as an outcome. The work builds on their experience conducting research involving patients with sickle cell disease and on previous work from the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core.

The authors offer 7 recommendations to address ethical considerations in the development of protocols, procedures, and monitoring activities related to suicidality in depressed patients in a pragmatic clinical trial.

Recommendations:

  • Understand our responsibility to act
  • Define triggers for action
  • Examine responsibilities for action
  • Protect patient autonomy and privacy
  • Identify indirect and collateral participants
  • Mitigate the risk of bias
  • Integrate responses within the clinical practice and understand the sociotechnical considerations.

Severe depression symptoms such as suicidal ideation can be assessed in patients using the PHQ-9, a validated self-report instrument used to score depression severity by inquiring about the  presence and severity of depression, passive thoughts of death, and active ideas of self-harm.

For more, read the full article or the article Responding to Signals of Mental and Behavioral Health Risk in PCTs from the Ethics and Regulatory Core.

The GRACE is supported by the NIH through the NIH HEAL Initiative under an award administered by the National Center for Complementary and Integrative Health. Learn more about the GRACE trial.

Community-Based Participatory Research Practices in the GRACE Trial

Community-Based Participatory Research Practices in the GRACE Trial

Description

Building trust in communities is critical for long-term partnerships between patients and researchers. In this video, Dr. Judith Schlaeger, Co-PI of the GRACE Trial, describes her team's efforts to engage patients and community-based organizations.

Biography

Headshot of Dr. Judith Schlaeger

Judith Schlaeger, PhD, CNM, LAc, FACNM, FAAN
Associate Professor, University of Illinois Chicago
GRACE NIH Collaboratory Trial co-PI

 

Related

Deciding Who to Engage

View the full Grand Rounds video

October 5, 2023: GRACE Trial Featured on CBS News Chicago for Sickle Cell Awareness Month

The GRACE trial, an NIH Pragmatic Trials Collaboratory Trial, was featured in a segment on CBS News Chicago. Co–principal investigator Ardith Doorenbos was interviewed for the segment as part of the news program’s observance of Sickle Cell Awareness Month.

“Millions of people around the world with sickle cell disease really suffer from very serious chronic pain, which impacts all their life experiences,” Doorenbos said. “What the GRACE trial is doing is taking a look at 2 different nonpharmacological treatment modalities that we can use to better control pain.”

View the full news segment.

The GRACE trial is studying real-world implementation of acupuncture and guided relaxation for patients with pain associated with sickle cell disease. The study is supported by the NIH through the NIH HEAL Initiative under an award administered by the National Center for Complementary and Integrative Health. Learn more about the GRACE trial.

July 19, 2022: Three PRISM NIH Collaboratory Trials Share Latest Updates and Accomplishments

At the NIH Pragmatic Trials Collaboratory’s annual Steering Committee meeting this spring, we interviewed investigators from 3 of the PRISM NIH Collaboratory Trials to discuss their progress in the first year of study implementation. All of the studies began enrollment last year.

The PRISM program (Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing) is a component of the NIH’s Helping to End Addiction Long-term (HEAL) Initiative. The PRISM NIH Collaboratory Trials are studying the real-world effectiveness of nonpharmacologic interventions for pain and assessing the implementation of these interventions to improve pain management and reduce reliance on opioids. The NIH Collaboratory Coordinating Center serves as the PRISM Resource Coordinating Center.

BeatPain Utah is a pragmatic trial of nonpharmacologic pain management interventions in primary care clinics of US federally qualified health centers in Utah. The interventions are designed to overcome barriers specific to rural and lower-income communities through innovative use of telehealth resources. The study is administered by the National Institute of Nursing Research and is being conducted by Dr. Julie Fritz of the University of Utah. Learn more about BeatPain Utah.

The GRACE trial is a hybrid effectiveness–implementation trial of guided relaxation and acupuncture for pain associated with chronic sickle cell disease in 3 large healthcare systems. The study is administered by the National Center for Complementary and Integrative Health and is being conducted by Drs. Ardith Doorenbos, Judith Schlaeger, Robert Molokie, and Miriam Ezenwa of the University of Illinois Chicago and Dr. Nirmish Shah of Duke University. Learn more about GRACE.

OPTIMUM is evaluating the impact of an innovative, group-based mindfulness program for patients with chronic low back pain in real-world clinical settings. Mindfulness is effective for the treatment of chronic low back pain but remains underutilized as it has not been regularly woven into outpatient clinical settings. The study is administered by National Center for Complementary and Integrative Health and is being conducted by Dr. Natalia Morone of Boston University and Boston Medical Center. Learn more about OPTIMUM.

See also our recent interviews with the principal investigators of our other PRISM NIH Collaboratory Trials:

Headshots of Julie Fritz, Ardith Doorenbos, and Natalia Morone

March 31, 2022: GRACE Trial Has New Study Snapshot, Updated Ethics and Regulatory Documentation

GRACE Trial logoA downloadable study snapshot and updated ethics and regulatory documentation are now available for the GRACE trial, an NIH Pragmatic Trials Collaboratory Trial.

GRACE transitioned from the planning phase to the implementation phase in September. As part of the transition, the study team reviewed and updated the minutes of their initial consultation with the Ethics and Regulatory Core. The study is a hybrid effectiveness–implementation trial of guided relaxation and acupuncture for pain associated with chronic sickle cell disease in 3 large healthcare systems.

  • Read the updated ethics and regulatory documentation, including information about the study team’s approach to inclusion and exclusion criteria, informed consent, and collection of patient-reported outcome data.
  • Also available is a new study snapshot for GRACE. This downloadable handout summarizes the study’s aims, lessons from the planning phase, and links to other resources from this innovative pragmatic clinical trial.

GRACE is supported by the NIH through the NIH Heal Initiative under an award from the National Center for Complementary and Integrative Health. Learn more about the GRACE trial.