NIH HEAL Initiative

April 24, 2023: Webinar Will Highlight Meaningful Engagement of Patients and Communities in NIH HEAL Initiative Studies

Posted on by Damon Seils

HEAL Headliners: Engaging Patients and Communities in HEAL Research

An upcoming webinar in the NIH HEAL Initiative’s HEAL Headliners series will highlight the experiences of 2 projects in meaningfully engaging patients and community partners throughout the research process to ensure that the findings have the greatest public health impact. The webinar will be held on Friday, May 5, 2023, at 2:00 pm eastern.

Rosemarie Martin of Brown University and Linda Hurley of CODAC Behavioral Heathcare will report on a study of a systems-change approach for increasing use of medications for opioid use disorder across 7 probation and parole sites to improve linkage of justice-involved individuals to evidence-based treatment. In addition, Kirsten Johansen of Hennepin Healthcare will describe the role of patient and community engagement in the HOPE clinical trial of tailored patient-centered interventions to manage pain and reduce opioid use among patients receiving hemodialysis.

HEAL Headliners: Engaging Patients and Communities in HEAL Research
Venue: Live online via Zoom
Date and Time: May 5, 2023; 2:00 pm ET
Register free online

October 17, 2022: NINR to Host Webinar for NIH HEAL Initiative Funding Opportunity

Posted on by Damon Seils

NINR logoThe National Institute of Nursing Research (NINR) will host a webinar for its recent request for applications, “RFA-NR-23-001, HEAL Initiative: Prevention and Management of Chronic Pain in Rural Populations (UG3/UH3 Clinical Trial Required).” The webinar will describe key features of the funding opportunity, review the interests of participating Institutes and Centers, and address questions from potential applicants.

The NIH HEAL Initiative℠, or Helping to End Addiction Long-Term Initiative℠, previously announced this new funding opportunity for cooperative research that will accelerate implementation of nonopioid interventions for chronic pain management in rural and remote populations. The initiative will support pragmatic, implementation, and hybrid effectiveness-implementation trials that study strategies for equitably and efficiently implementing effective interventions and evidence-based pain management guidelines in rural and remote communities.

The webinar is optional and not required for application submission. Preregistration is require. Participants are encouraged to submit their questions in advance of the webinar to NINRProgram@nih.gov.

NIH HEAL Prevention and Management of Chronic Pain in Rural Populations Technical Assistance Webinar: RFA-NR-23-001
Date: Monday, October 24, 2022
Time: 12:00-1:00pm ET

Webinar Registration Link:
https://us02web.zoom.us/webinar/register/WN_ajgNL7u3TQy9RnsN3BgM1g

August 18, 2022: Rural and Remote Populations Are Focus of Funding Opportunity From NIH HEAL Initiative

Posted on by Damon Seils

NIH Heal Initiative logoThe NIH HEAL Initiative℠, or Helping to End Addiction Long-Term Initiative℠, announced its intent to publish a new funding opportunity for cooperative research that will accelerate implementation of nonopioid interventions for chronic pain management in rural and remote populations. The initiative will support pragmatic, implementation, and hybrid effectiveness-implementation trials that study strategies for equitably and efficiently implementing effective interventions and evidence-based pain management guidelines in rural and remote communities.

The funding opportunity announcement is expected to be published in fall 2022, with an expected application due date in winter 2022. Funded projects will become part of the NIH HEAL Initiative’s PRISM (Pragmatic and Implementation Studies to Improve the Management of Pain and Reduce Opioid Prescribing) program.

The NIH Collaboratory Coordinating Center serves as the PRISM Resource Coordinating Center. Six PRISM NIH Collaboratory Trials within the NIH Collaboratory 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.

Read the complete Notice of Intent to Publish a Funding Opportunity Announcement for HEAL Initiative: Prevention and Management of Chronic Pain in Rural Populations (UG3/UH3, Clinical Trials Required).

August 11, 2022: New Funding Opportunities From NIH HEAL Initiative Will Support Sickle Cell Disease Pain Management

Posted on by Damon Seils

NIH Heal Initiative logoThe Helping to End Addiction Long-Term Initiative℠, or NIH HEAL Initiative℠, recently published 2 funding opportunity announcements soliciting applications focused on sickle cell disease (SCD) pain management. The effort is co-led by the National Center for Complementary and Integrative Health and the National Heart, Lung, and Blood Institute, with support from other NIH Institutes, Centers, and Offices.

  • RFA-AT-23-001, “HEAL Initiative: Pragmatic and Implementation Studies for the Management of Sickle Cell Disease Pain” (UG3/UH3, Clinical Trials Optional) will support multisite embedded pragmatic or implementation trials to inform the uptake of pharmacologic, nonpharmacologic, and/or multicomponent approaches for acute and/or chronic SCD pain management in healthcare systems that serve the SCD population.
  • RFA-AT-23-002, “HEAL Initiative: Sickle Cell Disease Pain Management Trials Utilizing the Pain Management Effectiveness Research Network Cooperative Agreement” (UG3/UH3, Clinical Trial Required), will support multisite effectiveness clinical trials of pharmacologic, nonpharmacologic, and/or multicomponent approaches for acute and/or chronic SCD pain management, allowing continued opioid pain management as needed.

August 9, 2022: NIH HEAL Initiative Announces Funding Opportunity for Prevention Research in Community Health Centers

Posted on by Damon Seils

NIH Heal Initiative logoThe Helping to End Addiction Long-Term Initiative℠, or NIH HEAL Initiative℠, is seeking applications for opioid misuse prevention research in community health centers.

The funding opportunity announcement, RFA-DA-23-048: HEAL Initiative: Research Studies to Develop and Implement Interventions to Prevent Opioid Misuse in Community Health Centers, supports interdisciplinary teams to study the development, adaptation, and/or implementation of interventions to prevent misuse of opioids and other substances. Research will be supported through exploratory/developmental phase awards that may not exceed 5 years, allocating up to 2 years of funding for development of the project and up to 4 years for a full test of the research aims. Applications are due November 8, 2022.

The National Institute on Drug Abuse will hold a webinar on September 6 for potential applicants. Register for the webinar.  For more information, contact Sarah Steverman at sarah.steverman@nih.gov.

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

June 30, 2022: BackInAction Is Back on Track After COVID-19 Delays

Posted on by Elizabeth Mccamic

Karen J. Sherman, PhD, MPH
Dr. Karen Sherman

In connection with the NIH Pragmatic Trials Collaboratory Steering Committee meeting and 10th anniversary celebration, we sat down for an interview with Drs. Karen Sherman and Lynn DeBar to get an update on the Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults (BackInAction) NIH Collaboratory Trial. BackInAction is a pragmatic randomized trial to evaluate the safety and effectiveness of treatments for older adults with chronic low back pain. The study team is conducting a 3-arm trial of adults 65 years or older with low back pain to evaluate acupuncture vs usual care.

What is the current status of the BackInAction trial?
BackInAction has recruited about two-thirds of its participants and is on track to complete recruitment next fall. We also are providing acupuncture and doing follow-up interviews, so the trial is in the “ongoing phase.”

What challenges have you faced, and how have you dealt with them?
Our biggest challenges have been associated with COVID-19 impacts. Given the higher risk and vulnerability for our older adult target population and the requirement for in-person treatment (acupuncture), we delayed the start of recruitment by many months to ensure that those outreached had ample opportunity to be vaccinated beforehand and have also paused recruitment commensurate with regional surges of COVID variants at one or more of our clinical sites as needed. We also vetted the community acupuncturists who provide acupuncture to our study participants to ensure adequate COVID-safe office practices.

Lynn DeBar, PhD, MPH
Dr. Lynn DeBar

Unrelated to COVID-19, escalating thresholds for regulatory and security features resulted in a previously approved event tracking and recruitment and assessment software system not passing the Technology Resource Office (TRO) review at multiple clinical sites and the consequent need to align data collection and aggregation from site-specific systems. TRO reviews established for clinical care software and processes for our healthcare systems increasingly restrict clinical research practices as well.

What impact do you hope your trial will have on real-world healthcare?
The grant was funded as part of the NIH HEAL Initiative's PRISM program, and the specific funding opportunity announcement was issued because Medicare was interested in additional nonpharmacological treatment options for older adults with chronic low back pain. We had thought that they would be using data from the trial for a coverage decision, since few data on acupuncture existed for older adults. We hope that the trial results will assist the Centers for Medicare & Medicaid Services in any further refinements related to coverage of acupuncture for older adults with chronic low back pain.

How has being part of the NIH Pragmatic Trials Collaboratory shaped your project?
It’s helpful to have the sounding board of regular contact with principal investigators and research teams grappling with often similar issues that arise in implementing pragmatic trials (Steering Committee meetings, annual meetings, and Core Working Groups). Feedback from the Biostatistics and Study Design Core has been particularly helpful, as has the PRISM-wide help selecting and coordinating an appropriate data repository for required HEAL common data elements. Although there have been a few instances when we’ve been surprised by and needed to correct study-specific information included in cross-site dissemination products (always given ample opportunity to do so), we’re very aware and grateful for the functionality of the program’s Coordinating Center and infrastructure in contrast to some of the more recently established Coordinating Center infrastructures for related NIH sub-initiatives. The NIH Pragmatic Trials Collaboratory is much more an aid than a hindrance!

May 17, 2022: NIH and Program Leaders Discuss PRISM’s Role in NIH HEAL Initiative

Posted on by Elizabeth Mccamic

In an interview at the NIH Pragmatic Trials Collaboratory Steering Committee’s annual meeting in April, Dr. Rebecca Baker, Dr. Adrian Hernandez, and Dr. Wendy Weber discussed how the PRISM program and the NIH HEAL Initiative are working together to answer questions about pain management and the national opioid public health crisis.

Baker is the director of the NIH HEAL Initiative, and Hernandez is co-principal investigator of the NIH Pragmatic Trials Collaboratory Coordinating Center, for which Weber is the NIH Project Officer.

“I think the PRISM program is a great piece of the NIH HEAL initiative,” said Weber. “The HEAL initiative has everything from basic science all the way up to what PRISM is doing, which is taking these effective interventions and actually figuring out how do you put them into the healthcare system.”

The Helping to End Addiction Long-term Initiative (NIH HEAL Initiative) is an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis. It has launched more than 600 different research projects, totaling a more than $2 billion investment.

The PRISM program (Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing) is a component of the NIH HEAL Initiative, and the NIH Pragmatic Trials Collaboratory serves as the PRISM Resource Coordinating Center, supporting large-scale embedded pragmatic clinical trials to determine the effectiveness of non-opioid interventions for pain.

“When we talk about learning in the healthcare system, this is an area that we see is going to have continuous learning, and so, as there are new options for pain management, how do you get them implemented into practice, what are the gaps, what else is needed for these areas,” said Hernandez. “This becomes a hallmark of what we are aiming to do for the NIH Pragmatic Trials Collaboratory.”

PRISM and the NIH HEAL Initiative have developed common measures across studies in order to create a HEAL data ecosystem that will allow investigators to do meta-analyses with shared outcome measures across studies.

“One thing that we’ve learned through HEAL, especially in our focus on pain, but also for addiction, is that these conditions don’t exist in isolation, so people rarely have just pain—they have pain plus other health conditions,” said Baker. “Being able to study that in a pragmatic way and iterate around different types of patients enriches the knowledge that comes out of the study and then enables clinicians to provide great care, too.”

Through key partnerships with the NIH Pragmatic Trials Collaboratory, PRISM, and other federal partners, the NIH HEAL Initiative is now integrating the experience of patients at the outset of studies and focusing on health disparities and health inequity issues.

“If we just conduct research, publish the papers, go to academic meetings and discuss them, we’re not going to have the impact we’re hoping to have through this initiative, and so the next phase is continuing to expand our research into these domains that we weren’t able to start with at the beginning but also continue to build those partnerships for dissemination and implementation,” said Baker.

View the full interview.

See the complete materials from the 2022 Steering Committee meeting.

January 20, 2021: New Article Explores Ethical Obligation to Monitor Signals of Behavioral and Mental Health Risk in Pragmatic Trials

Posted on by Karen Staman

In a new Contemporary Clinical Trialslsarticle, members of the Ethics and Regulatory Core of the NIH Pragmatic Trials Collaboratory explore the ethical obligation of investigators to address signals of behavioral and mental health risk in pragmatic clinical trials.

The article was published online ahead of print in Contemporary Clinical Trials and will appear in a forthcoming special issue on pragmatic and virtual trials.

Some pragmatic trials collect sensitive data that could signal distress, such as suicidal ideation, opioid use disorder, or depression. Investigators have an ethical obligation to monitor these signals and identify in advance if, when, and how such signals will trigger a response. Using examples from the NIH Collaboratory Trials, the authors offered preliminary recommendations and identified opportunities for future work.

The NIH Collaboratory Trials discussed in the article are supported by the PRISM program—Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing. The projects are studying the real-world effectiveness of nonpharmacologic interventions to improve pain management and reduce reliance on opioids.

Read the full article.

The PRISM program is a part of the Helping to End Addiction Long-Term Initiative℠, or NIH HEAL Initiative℠. The NIH Pragmatic Trials Collaboratory Coordinating Center serves as the PRISM Resource Coordinating Center.

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.