GRACE

December 14, 2021: A Year of New Insights From the NIH Collaboratory

Posted on by Damon Seils

Collage of journal coversNIH Collaboratory researchers in 2021 shared study results, generated new knowledge, and developed innovative research methods in pragmatic clinical trials. Their work included insights from the Coordinating Center and Core Working Groups, analyses from the NIH Collaboratory Distributed Research Network, and results and methodological approaches from the NIH Collaboratory Trials.

So far this year, the NIH Collaboratory has produced 3 dozen articles in the peer-reviewed literature, including the primary results of the PPACT and TSOS trials, the study design of the Nudge and OPTIMUM studies, insights into the COVID-19 pandemic from the EMBED and ACP PEACE studies, and more:

NIH Collaboratory Coordinating Center

NIH Collaboratory Distributed Research Network

ACP PEACE NIH Collaboratory Trial

BackInAction NIH Collaboratory Trial

EMBED NIH Collaboratory Trial

GRACE NIH Collaboratory Trial

HiLo NIH Collaboratory Trial

LIRE NIH Collaboratory Trial

Nudge NIH Collaboratory Trial

OPTIMUM NIH Collaboratory Trial

PPACT NIH Collaboratory Trial

PRIM-ER NIH Collaboratory Trial

PROVEN NIH Collaboratory Trial

SPOT NIH Collaboratory Trial

TSOS NIH Collaboratory Trials

December 13, 2021: BeatPain Utah and GRACE Begin Enrollment in Studies of Nonpharmacologic Pain Management

Posted on by Damon Seils
Headshot of Dr. Julie Fritz
Dr. Julie Fritz, BeatPain Utah

The BeatPain Utah study and the GRACE trial have begun enrollment of study participants. Both projects were awarded continuation into the UH3 implementation phase in the summer. The studies make up the second cohort of NIH Collaboratory Trials to be supported through the NIH HEAL Initiative’s PRISM program.

Congratulations to both study teams for reaching this important project milestone!

BeatPain Utah is studying real-world implementation of a telehealth physical therapy strategy for patients with chronic back pain in primary care clinics of federally qualified health centers. Learn more about BeatPain Utah in this interview with principal investigator Dr. Julie Fritz. BeatPain Utah is supported by the NIH through the NIH Heal Initiative under an award from the National Institute of Nursing Research.

The GRACE trial is studying real-world implementation of acupuncture and guided relaxation for patients with pain associated with sickle cell disease. Learn more about GRACE in this interview with co–principal investigator Dr. Robert Molokie. GRACE is supported by the NIH through the NIH HEAL Initiative under an award from the National Center for Complementary and Integrative Health.

Combined headshots of Drs. Ardith Doorenbos, Judith Schlaeger, Robert Molokie, Miriam Ezenwa, and Nirmish Shah
GRACE co–principal investigators Drs. Ardith Doorenbos, Judith Schlaeger, Robert Molokie, Miriam Ezenwa, and Nirmish Shah

The PRISM projects—Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing—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.

September 30, 2021: BeatPain Utah and GRACE Awarded Continuation to Implementation Phase

Posted on by Damon Seils

The NIH Collaboratory is pleased to announce that the BeatPain Utah and GRACE NIH Collaboratory Trials received approval this month to transition from the planning phase to the implementation phase of their studies. As projects funded through the NIH HEAL Initiative’s PRISM program, these pragmatic clinical trials embedded in healthcare systems are directly addressing the US opioid crisis by exploring the implementation of novel, nonpharmacologic interventions for pain management.

Congratulations to the BeatPain Utah and GRACE principal investigators and their study teams for reaching this important milestone!

BeatPain Utah: Nonpharmacologic Pain Management in FQHC Primary Care Clinics

Headshot of Dr. Julie Fritz
Dr. Julie Fritz

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 will be 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.

 

 

 

 

GRACE: Hybrid Effectiveness-Implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain

Headshots of Drs. Ardith Doorenbos, Judith Schlaeger, Robert Molokie, Miriam Ezenwa, and Nirmish Shah
Left to right: Drs. Ardith Doorenbos, Judith Schlaeger, Robert Molokie, Miriam Ezenwa, and Nirmish Shah

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, Miriam Ezenwa of the University of Illinois Chicago and Dr. Nirmish Shah of Duke University.

 

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 NIH Collaboratory serves as the PRISM Resource Coordinating Center and is supported by the National Center for Complementary and Integrative Health. Support is also provided by the NIH Common Fund through a cooperative agreement from the Office of Strategic Coordination within the Office of the NIH Director.

August 19, 2021: Biostatistics Core Helps Projects ‘Roll With the Punches’ of the Pandemic

Posted on by Damon Seils

Leaders of the NIH Collaboratory’s Biostatistics and Study Design Core Working Group spoke in a recent interview about the impacts of the COVID-19 pandemic on the NIH Collaboratory Trials, including the 2 newest projects, BeatPain Utah and GRACE.

“BeatPain Utah and GRACE are fascinating studies, as all our NIH Collaboratory Trials are, and are giving us lots of food for thought at the Biostatistics Core,” said Dr. Liz Turner, associate professor of biostatistics and bioinformatics at Duke University and a cochair of the Core. View the full video.

The 2 studies “have been pretty well positioned to roll with some of the distancing required or the lack of in-person visits,” said Dr. Patrick Heagerty, professor of biostatistics at the University of Washington and the other cochair of the Core. “The BeatPain project had a remote delivery from the beginning, so I think the impact of COVID was not as dramatic as it’s been for other projects. But GRACE, where acupuncture is part of it, they have to figure out what are the elements of the research protocol they can do remotely but still need to get folks in person to do that acupuncture,” Heagerty said.

“There really have been some considerable challenges for several of the other NIH Collaboratory Trials,” said Turner. “Good examples of these challenges are those faced by 2 stepped-wedge cluster randomized trials, ACP PEACE and PRIM-ER. …They had to really restructure the design and respond very quickly to what was happening in practice out in the field. Interestingly, on the flip side, the disruptions last spring in 2020 did provide opportunities to address other research questions and perhaps generate other interesting evidence,” Turner said.

(Learn more about the ACP PEACE study’s COVID-19 supplement: “Can a Primary Care Telehealth Intervention Change the Paradigm for Advance Care Planning?”)

Heagerty and Turner also described ongoing projects of the Core to support pragmatic research, including guidance on longitudinal analysis in randomized trials, considerations for studies with multiple outcomes, and handing of studies with variable cluster sizes. Learn more about the Biostatistics and Study Design Core.

 

Screen shot of interview with Patrick Heagerty and Liz Turner

August 9, 2021: ‘Pause’ for COVID-19 Complicates Research Embedded in Healthcare Systems

Posted on by Damon Seils

Leaders of the NIH Collaboratory’s Health Care Systems Interactions Core Working Group spoke in a recent interview about the impacts of the COVID-19 pandemic on the NIH Collaboratory Trials.

“Some of the projects are facing healthcare systems that are on pause for research,” said Leah Tuzzio, a senior research associate at Kaiser Permanente Washington Health Research Institute (KPWHRI) and a member of the Core. “It’s happened before when policy changes or when [electronic health record] systems change or when someone important leaves, but the pandemic has had a huge impact,” she said.

“Healthcare systems are strongly influenced by the environment and by changes in their environment, and so any pragmatic trial that’s really embedded in the healthcare system will be affected by the environment around it,” said Dr. Eric Larson, a KPWHRI senior investigator and the chair of the Core. Healthcare systems participating in the NIH Collaboratory NIH Collaboratory Trials have been overwhelmed by their number one priority, which—in addition to caring for their patients—is adapting to COVID, Larson said.

In addition to guiding the NIH Collaboratory Trials through pandemic-related challenges, the Health Care Systems Interactions Core has been working on several long-term projects.

“One of the things that we’re currently working on is a typology of the healthcare systems that have participated in [the GRACE and BeatPain Utah NIH Collaboratory Trials] as well as the projects that came before,” said Core project manager Rachel Hays. The Core is surveying NIH Collaboratory Trial investigators about what lessons they would pass on to future pragmatic trial investigators about building partnerships with their participating healthcare systems, she said.

 

Screen shot of interview with Eric Larson, Leah Tuzzio, and Rachel Hays
Dr. Eric Larson, Leah Tuzzio, and Rachel Hays

August 5, 2021: GRACE Trial Seeks More Options for Sickle Cell Pain

Posted on by Damon Seils

The GRACE trial, an NIH Collaboratory Trial, is studying real-world implementation of nonpharmacologic pain management strategies for patients with sickle cell disease. Dr. Robert Molokie, a GRACE co–principal investigator, discussed the study in a Zoom-based interview after the NIH Collaboratory’s annual steering committee meeting.

One innovation the GRACE trial is bringing to the NIH Collaboratory’s portfolio of pragmatic trials is its use of a sequential, multiple-assignment, randomized trial (SMART) design. In this adaptive approach, patients are randomly assigned to treatment groups, and those who do not respond to the treatment undergo a secondary randomization to either continue with the initial intervention or switch to the other group.

The GRACE trial is studying acupuncture and guided relaxation with the goals of reducing pain and reducing patients’ reliance on opioid medication.

Using a pragmatic, adaptive design, Molokie said, “I think we will get the most realistic findings of how these therapeutic interventions work, whereas in more classic trials they’re going to end up with such a group of selected patients that it may not be as generalizable as a pragmatic clinical trial.” Molokie is a clinical associate professor of medicine at the University of Illinois Chicago.

GRACE is supported by the NIH through the NIH HEAL Initiative under a grant from the National Center for Complementary and Integrative Health and receives logistical and technical support from the PRISM Resource Coordinating Center.

 

Screen shot of interview with Dr. Robert Molokie
Dr. Robert Molokie

July 26, 2021: NIH Collaboratory Leaders Discuss PRISM Projects, New Initiatives, and the Future of the Program

Posted on by Damon Seils

In a recent interview, Dr. Wendy Weber shared that the National Advisory Council for Complementary and Integrative Health has approved a concept for the NIH Collaboratory to continue with the support of NIH Institutes and Centers, as the program completes its term as an NIH Common Fund initiative.

 

 

“We’re quite excited for some new directions in where we’re going to head with this program, and really excited that we’ve identified a number of partners across the NIH as different Centers, Institutes, and Offices that want to continue this program and want to continue to do research embedded in healthcare systems,” Weber said.

Weber is the branch chief for the Clinical Research in Complementary and Integrative Health Branch in the Division of Extramural Research at the National Center for Complementary and Integrative Health (NCCIH) and serves as the program officer for the NIH Collaboratory.

“I think one new direction for us is looking at how do we address health disparities in healthcare systems, what types of interventions can actually improve those disparities and improve the quality of care so that we have less differences in the way patients are treated within the healthcare delivery system,” Weber said.

We interviewed Weber after the NIH Collaboratory’s annual steering committee meeting, along with Dr. Robin Boineau, the project scientist for the NIH Collaboratory, and Dr. Kevin Weinfurt, a professor in population health sciences at Duke University and a co–principal investigator for the NIH Collaboratory Coordinating Center. View the full interview.

The 3 leaders talked about the program’s newest NIH Collaboratory Trials—BeatPain Utah and GRACE—and their role in advancing the goals of the NIH Collaboratory. They also discussed focus areas for the coming year, including greater attention to implementation science outcomes, diversity in pragmatic trials, and lessons from the COVID-19 pandemic.

“[BeatPain Utah and GRACE] are helping the Collaboratory to learn how to design, analyze, and interpret adaptive designs,” said Weinfurt. “These are our 2 first trials where we’re using adaptive designs. One of the goals of the Collaboratory is to generate generalizable knowledge about how to do pragmatic trials, so we like these types of learning opportunities,” he said.

Boineau highlighted the Diversity Workshop Grand Rounds Series, which began in May and is ongoing. The series is focused on strategies for improving diversity in pragmatic clinical trials and is “an important next step to really think together about where we can go and what we can do to really build this community of investigators and participants,” Boineau said.

 

Screen shot of Dr. Wendy Weber interview
Dr. Wendy Weber of NCCIH, program officer for the NIH Collaboratory

February 8, 2021: Meeting Minutes are Available from the Ethics and Regulatory Core Discussions with the PRISM NIH Collaboratory Trials

Posted on by Gina Uhlenbrauck

Meeting minutes, supplementary materials, and updates are available that summarize recent discussions related to the ethics and regulatory issues associated with the six PRISM NIH Collaboratory Trials:

These discussions, which took place by teleconference, included representation from study principal investigators and study teams, members of the NIH Collaboratory Ethics and Regulatory Core, NIH staff, and NIH Collaboratory Coordinating Center personnel as well as some IRBs responsible for oversight of the projects.

November 9, 2020 Virtual Onboarding Meeting: BeatPain Utah and GRACE

PRISM Onboarding Meeting

November 9, 2020
Virtual

Main Purpose

Welcome the new PRISM UG3 NIH Collaboratory Trials; provide introductions, an overview of the Collaboratory Program and the NIH HEAL Initiative, hear from the new UG3 PRISM Projects; and discuss lessons learned from the Collaboratory Projects.

Welcome and Opening Remarks
Helene Langevin, MD, CM; Richard Hodes, MD; Lesley Curtis, PhD

Overview of the NIH HCS Research Collaboratory Program
Cathy Meyers, MD

HEAL Initiative Overview
Rebecca Baker, PhD

Overview of a HEAL Cooperative Agreement
Wendy Weber, ND, PhD, MPH; Laura Wandner, PhD

Discussion From New UG3 NIH Collaboratory Trials

  • GRACE
    Ardith Z. Doorenbos, PhD, RN; Robert E. Molokie, MD; Judith M. Schlaeger, PhD, CNM; Miriam O. Ezenwa, PhD, RN; Nirmish Shah, MD

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

Panel:
Jerry Jarvik, MD, MPH; Doug Zatzick, MD; Miguel Vazquez, MD; Mike Ho, MD, PhD; Karen Sherman, PhD, MPH; Natalia Morone, MD

Closing Remarks
Helene Langevin, MD, CM; Richard Hodes, MD; Lesley Curtis, PhD

October 12, 2020: NIH Collaboratory Welcomes 2 New PRISM NIH Collaboratory Trials to Address the Opioid Epidemic

Posted on by Damon Seils

Logo for the NIH HEAL InitiativeThe NIH Collaboratory is adding 2 new NIH Collaboratory Trials to its portfolio of innovative pragmatic clinical trials embedded in healthcare systems. The 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.

The new PRISM awards total approximately $1.6 million in the initial planning phase and are supported by the HEAL Initiative and administered by 2 participating NIH institutes:

  • 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 will be 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 will be conducted by Dr. Julie Fritz of the University of Utah under grant award 1UG3NR019943-01.
  • The Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain (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 will be conducted by Drs. Ardith Doorenbos, Judith Schlaeger, Robert Molokie, Miriam Ezenwa of the University of Illinois at Chicago and Dr. Nirmish Shah of Duke University under grant award 1UG3AT011265-01.

In its role as the PRISM Resource Coordinating Center, the NIH Collaboratory will provide technical support and pragmatic trial expertise for the new NIH Collaboratory Trials. The PRISM Resource Coordinating Center is supported by NIH through the NIH HEAL Initiative.

The NIH Collaboratory aims to improve the way clinical trials are conducted by creating an infrastructure for collaborative research with healthcare systems. The Collaboratory has 5 Core Working Groups of experts that help research teams address challenges of conducting research embedded in clinical care, and they collect and disseminate knowledge and best practices learned throughout the process. The ultimate goal is to ensure that healthcare providers and patients can make decisions based on the best available clinical evidence.

The Helping to End Addiction Long-term Initiative℠, or NIH HEAL Initiative℠, is an aggressive, trans-NIH effort to speed scientific solutions to stem the national opioid public health crisis. Launched in April 2018, the initiative is focused on improving prevention and treatment strategies for opioid misuse and addiction, and enhancing pain management. For more information, visit heal.nih.gov.