GRACE

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

Posted on by Karen Staman

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

Posted on by Damon Seils

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: Inclusion of Diverse Participants in Pragmatic Clinical Trials: Meeting Participants Where They Are – Outreach, Trust, and Consent to Maximize Diversity

View the complete collection of Diversity Workshop video modules.

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

Posted on by Damon Seils

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

Posted on by Damon Seils

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

Posted on by Damon Seils

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.

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