NIH HEAL Initiative

March 9, 2020: AcuOA to Inform Medicare Coverage Decisions on Acupuncture: An Interview With Dr. Karen Sherman and Dr. Lynn Debar

Posted on by Damon Seils

Evidence supporting the safety and effectiveness of treatments for chronic low back pain in older adults is lacking. Although acupuncture is known to be effective in younger adults, clinical trials of acupuncture have rarely included older adults, a population with greater comorbidity and different healthcare needs.

The Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults (AcuOA), a new NIH Collaboratory Demonstration Project, will address this evidence gap by comparing acupuncture with usual care in a population of older adults with chronic low back pain. We spoke with co–principal investigators Dr. Karen Sherman and Dr. Lynn DeBar about the study at the NIH Collaboratory PRISM kickoff meeting in November.

“In an efficacy trial, you would sort out people—they would have to be healthy enough, they maybe wouldn’t have any comorbidities—and they’d get a specified course of treatment, everything would be dictated,” said Dr. Sherman. “But with older adults,” she explained, “most of the individuals would not be eligible for that kind of trial. So a pragmatic trial allows us to ask questions that are valuable to the population.”

Dr. DeBar added, “We’re really interested in how this plays out across different kinds of healthcare systems. We’re looking at this across varied delivery systems with a hope that what we find is very generalizable.”

Another aim of AcuOA is to conduct a cost-effectiveness analysis of the study’s acupuncture interventions. The study team will also conduct qualitative evaluations to describe barriers to and facilitators of the adoption, implementation, and sustainability of acupuncture treatment for older adults.

“Another interesting piece of this is that this is also for [the Centers for Medicare & Medicaid Services] to evaluate whether acupuncture will be one of the covered services under Medicare,” added Dr. DeBar. “So we will be working in some partnership with them on that,” she said.

The AcuOA trial is a project of the PRISM program (Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing), part of the NIH’s Helping to End Addiction Long-term (HEAL) Initiative. The NIH Collaboratory serves as the PRISM Resource Coordinating Center.

“The Collaboratory has a great deal of experience doing all kinds of things, and they also seem to be quite interested in new challenges and the idea that we’re going to be giving them some new challenges,” said Dr. Sherman. “We hope to learn more about pragmatic clinical trials and moving the methodology forward,” she said.

Dr. DeBar added, “It’s also really exciting that there are 4 of these [new Demonstration Projects] that are focused on similar populations of patients, a lot of non-pharmacotherapy treatment. So, while we’re the only ones focusing exclusively on acupuncture, I think we have a lot of synergies and a lot of ability to learn from one another.”

AcOA and the NIH Collaboratory PRISM Resource Coordinating Center are 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.

March 5, 2020: NOHARM to Test EHR-Embedded Clinical Decision Support for Postoperative Pain Care: An Interview With Dr. Andrea Cheville

Posted on by Damon Seils

Prescriptions for narcotic pain relief after surgery often lead to unintended prolonged opioid use. Nonpharmacologic approaches are effective and are recommended by clinical guidelines for postoperative pain but are rarely used as first-line or second-line therapy.

The Nonpharmacologic Options in Postoperative Hospital-based and Rehabilitation Pain Management (NOHARM) pragmatic trial, a new NIH Collaboratory Demonstration Project, will test a clinical decision support tool embedded in the electronic health record in 4 healthcare systems. We spoke with co–principal investigator Dr. Andrea Cheville about NOHARM at the NIH Collaboratory PRISM kickoff meeting in November.

“There are millions of surgeries performed every year in the United States, and many patients experience significant pain and loss of function afterwards,” explained Dr. Cheville. “Our hope is to introduce and increase the reliance on nonpharmacologic pain care, which is very safe and as or more effective than most of our medical pain-relieving strategies…to make that a more consistent and credible option for our patients and our clinicians,” she said.

Clinical decision support tools embedded in the electronic health record can be useful in encouraging patient-centered, guideline concordant care, but pragmatic strategies have not been tested pragmatically in postoperative pain care.

“We’re trying to target many, many points along well-established workflow. It would be very challenging in a conventional clinical trial paradigm to really test an intervention,” said Dr. Cheville.

The NOHARM trial is a project of the PRISM program (Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing), part of the NIH’s Helping to End Addiction Long-term (HEAL) Initiative. The NIH Collaboratory serves as the PRISM Resource Coordinating Center.

Dr. Cheville reflected on the exciting opportunity to participate the Collaboratory. “We are very excited to bring our novel use of the electronic health record as a critical and central intervention component and to bring that approach to the Collaboratory so we can both teach and learn as we move forward in this trial,” she said.

NOHARM is supported by the National Institute on Aging. The NIH Collaboratory PRISM Resource Coordinating Center is supported by the National Center for Complementary and Integrative Medicine. 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.

March 4, 2020: FM TIPS Explores Novel Fibromyalgia Treatment in Physical Therapy Practices: An Interview With Dr. Kathleen Sluka and Dr. Leslie Crofford

Posted on by Damon Seils

The recently completed Fibromyalgia Activity Study With TENS (FAST) established the efficacy of transcutaneous electrical nerve stimulation (TENS) for the treatment of musculoskeletal pain in patients with fibromyalgia. Physical therapists generally are trained in the use of TENS, but the technique is underused in clinical practice.

The Fibromyalgia TENS in Physical Therapy Study (FM TIPS), a new NIH Collaboratory Demonstration Project, will assess the feasibility of adding TENS to routine physical therapy for patients with fibromyalgia. In addition to evaluating symptom improvement, the study will measure the effect of TENS on adherence to physical therapy, achieving therapeutic goals, and medication use.

At the NIH Collaboratory PRISM kickoff meeting in November, we asked co–principal investigators Dr. Kathleen Sluka and Dr. Leslie Crofford to discuss the rationale for their study and the value of engaging with a network of experts in pragmatic clinical trials.

“Delivering [the intervention] and seeing how difficult it is to use in a clinical practice on a day-to-day basis—and delivering it to any patient who happens to have [the condition]—seems to me to be the best way to find out if it’s really going to work in clinical practice,” explained Dr. Sluka.

Dr. Crofford added, “What we’re aiming to do is to make it easy for the clinician to choose these nonpharmacologic strategies for treatment of pain that improve both symptom and function in patients with fibromyalgia.”

FM TIPS is a project of the PRISM program (Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing), part of the NIH’s Helping to End Addiction Long-term (HEAL) Initiative. The NIH Collaboratory serves as the PRISM Resource Coordinating Center.

“The Collaboratory has a wealth of expertise across multiple domains that can help us implement this and give us the knowledge we need in order to make this a successful trial,” said Dr. Sluka.

“We don’t think that anybody’s ever tried to do a pragmatic trial in physical therapy practice. So this is something that we hope that we can share back with the Collaboratory about how do you do this in nontraditional settings for research. We’re hoping to learn, and we hope they learn from us,” said Dr. Crofford.

FM TIPS is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. The NIH Collaboratory PRISM Resource Coordinating Center is supported by the National Center for Complementary and Integrative Medicine. 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.

March 2, 2020: OPTIMUM to Bring Mindfulness-Based Stress Reduction to the Clinic: An Interview With Dr. Natalia Morone

Posted on by Damon Seils

Chronic low back pain is among the most common conditions treated in primary care settings, yet treatment remains unsatisfactory for many patients. The American College of Physicians now recommends mindfulness-based stress reduction as initial treatment for patients with chronic low back pain. Yet, despite strong evidence of effectiveness, this therapy has not been integrated into clinical care.

OPTIMUM, a new NIH Collaboratory Trial, will study the integration of a group-based mindfulness program for chronic low back pain into usual care in primary care settings. We spoke with Dr. Natalia Morone, the principal investigator of OPTIMUM, at the NIH Collaboratory’s PRISM kickoff meeting in November about the rationale for her study and her hopes for advancing pragmatic clinical research.

“The efficacy studies have been done; they have been very rigorous randomized controlled trials,” Dr. Morone explained. “Now we need to demonstrate to stakeholders—to patients, to clinicians, to healthcare administrators—how this can actually be done in the clinic and what are the results when you now deliver this program in a real-world setting.”

OPTIMUM is supported by the PRISM program (Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing), part of the NIH’s Helping to End Addiction Long-term (HEAL) Initiative. The NIH Collaboratory Coordinating Center serves as the PRISM Resource Coordinating Center.

“I’m very excited to be in the Collaboratory, because it has been such a challenge bringing mindfulness and mindfulness-based stress reduction into the clinic,” Dr. Morone said. “I think our trial will really benefit from the collective experience and wisdom of the pragmatic trials that [the Collaboratory has] helped carry out.”

OPTIMUM and the NIH Collaboratory PRISM Resource Coordinating Center are 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.

February 28, 2020: Meeting Minutes from NIH Collaboratory’s Ethics and Regulatory Core Discussions with the PRISM NIH Collaboratory Trials

Posted on by Gina Uhlenbrauck

Meeting minutes and supplementary materials are available that summarize discussions related to the ethics and regulatory issues associated with each of the UG3 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.

February 4, 2020: NIH Videocast Will Offer Pre-Application Assistance for PRISM Funding Opportunity

Posted on by Damon Seils

The National Center for Complementary and Integrative Health (NCCIH) will hold an NIH Videocast on the recently reissued RFA-AT-20-004, “HEAL Initiative: Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) (UG3/UH3, Clinical Trials Optional).” The videocast, to be held on Monday, March 2, from 2:30 to 3:30 pm eastern, will provide an overview of the funding opportunity and address questions from potential applicants. The webinar is optional and not required for application submission.

The NCCIH, with other NIH Institutes, Centers, and Offices, reissued the funding opportunity announcement on January 23 to solicit applications for the PRISM program. The PRISM funding opportunity will prioritize pragmatic trials embedded in healthcare systems, with focus in the following areas:

  • pain management in emergency departments, dental clinics, primary care, and hospitals
  • chronic overlapping pain conditions
  • pain management in individuals at risk of or with opioid use disorder
  • pain management in those with co-occurring mental health disorders
  • noncancer pain management in persons with medical comorbid conditions

PRISM is part of the HEAL Initiative, which was created in April 2018 to speed scientific solutions for addressing the national opioid crisis.

January 7, 2020: NCCIH to Reissue PRISM Funding Opportunity and Host Pre-Application Webinar

Posted on by Damon Seils

The National Center for Complementary and Integrative Health (NCCIH), with other NIH Institutes, Centers, and Offices, will reissue a funding opportunity announcement to solicit applications for the HEAL Initiative’s Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) program. The NCCIH published its notice of intent to reissue the PRISM announcement to allow potential applicants time to develop proposals responsive to the funding opportunity. The reissuance is expected by January 30.

The NCCIH will host a pre-application webinar on March 2 to provide an overview of the PRISM funding opportunity and to address questions from potential applicants. The webinar is optional and not required for application submission.

The PRISM funding opportunity will prioritize pragmatic trials embedded in healthcare systems, with focus in the following areas:

  • pain management in emergency departments, dental clinics, primary care, and hospitals
  • chronic overlapping pain conditions
  • pain management in individuals at risk of or with opioid use disorder
  • pain management in those with co-occurring mental health disorders
  • noncancer pain management in persons with medical comorbid conditions

PRISM is part of the HEAL Initiative, which was created in April 2018 to speed scientific solutions for addressing the national opioid crisis.

November 26, 2019: PRISM Kickoff Meeting Welcomes New NIH Collaboratory Trials to NIH Collaboratory

Posted on by Damon Seils

The NIH Collaboratory welcomed 4 new NIH Collaboratory Trial teams last week during a kickoff meeting in Bethesda, Maryland. These pragmatic clinical trials embedded in healthcare systems are funded through the Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) program, a component of the NIH HEAL Initiative to address the opioid crisis.

PRISM NIH Collaboratory Trial Investigators
Left to right: Kathleen Sluka, PT, PhD (FM TIPS); Andrea Cheville, MD (NOHARM); Karen Sherman, PhD, MPH (AcuOA); Jon Tilburt, MD (NOHARM); Lynn DeBar, PhD, MPH (AcuOA); Leslie Crofford, MD (FM TIPS); and Natalia Morone, MD (OPTIMUM).

In its recently announced role as the PRISM Resource Coordinating Center, the NIH Collaboratory Coordinating Center will provide technical support and pragmatic trial expertise for the new NIH Collaboratory Trials. The projects address a range of questions related to pain management and opioid prescribing. They include:

  • AcuOA: Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults
  • FM TIPS: Fibromyalgia TENS in Physical Therapy Study
  • NOHARM: Non-pharmacological Options in Postoperative Hospital-Based and Rehabilitation Pain Management
  • OPTIMUM: Group-based mindfulness for patients with chronic low back pain in the primary care setting

Attendees of the PRISM kickoff meeting included the NIH Collaboratory Trial teams, NIH Collaboratory leadership and Coordinating Center faculty and staff, and representatives of several NIH Institutes, Centers, and Offices. The NIH Collaboratory Trial teams presented their studies to the full group for discussion. They then participated in individual breakout sessions with the Core Working Groups to discuss anticipated challenges in design, implementation, analysis, and dissemination.

October 15, 2019: Postdoctoral Fellowship in the Ethics and Regulatory Aspects of Pragmatic Clinical Trials at Johns Hopkins

Posted on by Gina Uhlenbrauck

The Johns Hopkins Berman Institute of Bioethics invites applications for a Postdoctoral Fellowship in the Ethics and Regulatory Aspects of Pragmatic Clinical Trials. This position includes pursuing independent research, working alongside faculty members involved with the ethics and regulatory aspects of large-scale pragmatic clinical trials (PCTs), and participating in the Hecht-Levi Postdoctoral Fellowship in Bioethics. The postdoctoral fellow is expected to pursue one or more projects addressing the ethics and regulatory aspects of PCTs in collaboration with Berman Institute faculty members. The Fellow will actively engage with the Ethics and Regulatory Core of the NIH Health Care Systems Research Collaboratory and the Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) Resource Coordinating Center.

Qualifications: Applications are welcome from candidates who will have an MD, PhD, or JD or their equivalent by the start date of the fellowship. Applicants should not have completed their terminal degree more than 3 years before the start date of the appointment. Physicians should not have completed a formal residency training program more than 3 years by the start date of the appointment.

Start date: September 1, 2020.

Terms of Appointment: The fellowship is guaranteed for 1 year with the expectation of a second year of funding, contingent on review. Applicants may not be employed by another institution and are expected to be in residence for the duration of the appointment.

How to apply: For details on how to apply see: https://bioethics.jhu.edu/education-training/fellowships/#fellowship-pragmatic. Applications must be submitted by December 16, 2019.

September 27, 2019: NIH Collaboratory to Serve as Coordinating Center for New Pragmatic Trials Addressing Opioid Crisis

Posted on by Gina Uhlenbrauck

The NIH Health Care Systems Research Collaboratory program is excited to announce that it has received funding to serve as the Resource Coordinating Center for a new group of large-scale embedded pragmatic clinical trials (ePCTs) on pain management and reducing opioid prescribing. As part of the NIH Collaboratory, the Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) Resource Coordinating Center will provide technical support and pragmatic trial expertise for the research that this program funds. PRISM trials will determine the effectiveness of multiple non-opioid interventions for treating pain and assess the impact of implementing interventions or guidelines to improve pain management and reduce reliance on opioids.

The PRISM Resource Coordinating Center funding and new research awards, described below, are part of the NIH’s Helping to End Addiction Long-term Initiative (NIH HEAL Initiative). This federal research initiative, launched in early 2018 by NIH Director Francis S. Collins, aims to apply scientific solutions to improve treatments for chronic pain, curb the rates of opioid use disorder and overdose, and achieve long-term recovery for opioid addiction.

“The NIH Collaboratory Coordinating Center is excited to be supporting these novel pragmatic trials that address an urgent health crisis. We hope the patients, clinicians, researchers, and health systems will benefit from knowledge we’ve gained supporting complex trials embedded in health care systems over the past 7 years, which will help deliver improvements in pain management to the American public faster.” – Adrian Hernandez, MD, MHS, Vice Dean for Clinical Research, Duke University School of Medicine.

The PRISM awards total approximately $35.7 million and are supported by 8 participating NIH institutes, centers, and offices. With these awards, the NIH Collaboratory will add 4 new large-scale ePCTs to its portfolio of innovative NIH Collaboratory Trials. The trials will be conducted at Boston Medical Center, Massachusetts; Kaiser Foundation Research Institute, California; Mayo Clinic, Minnesota; and University of Iowa. They include:

  • Non-pharmacological Options in postoperative Hospital-based And Rehabilitation pain Management (NOHARM) pragmatic clinical trial
  • Fibromyalgia TENS in Physical Therapy Study (TIPS): An embedded pragmatic clinical trial
  • Group-based mindfulness for patients with chronic low back pain in the primary care setting
  • Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults

The NIH Collaboratory aims to improve the way clinical trials are conducted by creating a new 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.

Related links:

NIH press release

Duke press release

NIH HEAL Initiative website

The Coordinating Center of the National Institutes of Health (NIH) Health Care Systems Research Collaboratory is supported by the NIH Common Fund through a cooperative agreement from the Office of Strategic Coordination within the Office of the NIH Director. Read more about the NIH Collaboratory Trials and the Core Working Groups.