Want to know more about the goals and challenges of the NIH Collaboratory’s PRISM NIH Collaboratory Trials? New downloadable handouts summarize the study aims, implementation lessons, and recent presentations from these innovative embedded pragmatic clinical trials (ePCTS).
The 2-page study snapshots are accessible from each NIH Collaboratory Trial page and the links below:
BackInAction: Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults
FM TIPS: Fibromyalgia TENS in Physical Therapy Study
OPTIMUM: Group-based Mindfulness for Patients with Chronic Low Back Pain in the Primary Care Setting
NOHARM: Nonpharmacologic Options in Postoperative Hospital-based and Rehabilitation Pain Management
The Helping to End Addiction Long-Term Initiative℠, or NIH HEAL Initiative℠, has created common data elements (CDEs) to facilitate cross-study comparisons for pain, improve interoperability of findings for patient-reported outcomes, and compare results across trials. The core CDEs were published recently in the NIH Collaboratory’s Living Textbook. They include CDEs for adult acute pain, adult chronic pain, and pediatric acute and chronic pain, and represent patient-reported outcomes that HEAL Initiative clinical trials are required to collect.
“Having common measures to capture the patient’s perspective regarding pain will enable researchers to compare meaningful data across pain conditions, in diverse populations, and in multiple research studies, including in pragmatic clinical research. This should greatly increase our understanding of pain and how best to treat it.”
The NIH Collaboratory serves as the resource coordinating center for 6 NIH Collaboratory Trials 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:
Because the PRISM studies are pragmatic clinical trials embedded in healthcare systems, it may not be feasible for investigators to collect all the required CDEs, as the trials need to be incorporated into clinical workflow with as little burden as possible. The NIH Collaboratory’s Patient-Centered Outcomes Core Working Group will work with the NIH Collaboratory Trials to understand and document which patient-reported outcome measures are collected and the perceived burden associated with collecting them.
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.
The NIH Collaboratory is pleased to announce that the four PRISM NIH Collaboratory Trials received approval to transition from the planning phase to the implementation phase of their studies. These embedded PCTs (ePCTs) are directly addressing the U.S. opioid crisis and exploring fundamental questions of pain management using nonpharmacologic treatments.
Congratulations to the PIs and study teams for their excellent work!
BackInAction: Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults
Karen Sherman, PhD, MPHLynn DeBar, PhD, MPH
BackInAction is conducting a three-arm pragmatic trial of older adults who have chronic low back pain to evaluate acupuncture versus usual care. The study will compare a standard 12-week course of acupuncture, an enhanced course of acupuncture (12-week standard course, plus 12-week maintenance course), and usual care to assess back-related function at 26 weeks.
FM TIPS: Fibromyalgia TENS in Physical Therapy Study
Kathleen Sluka, PT, PhDLeslie Crofford, MD
The aim of FM TIPS is to demonstrate the feasibility of adding transcutaneous electrical nerve stimulation (TENS) to the treatment of patients with fibromyalgia in a real-world physical therapy setting, and to determine if adding TENS to physical therapy reduces pain, increases adherence to physical therapy, and allows patients with fibromyalgia to reach their specific functional goals with less medication use.
NOHARM: Nonpharmacologic Options in Postoperative Hospital-based and Rehabilitation Pain Management
Andrea Cheville, MDJon Tilburt, MD
NOHARM is a stepped-wedge cluster-randomized trial that is testing a sustainable system-wide strategy for perioperative pain management using nonpharmacologic options in a manner that preserves patient function, honors patient values, and maintains availability of opioids as a last resort.
OPTIMUM: Group-based Mindfulness for Patients with Chronic Low Back Pain in the Primary Care Setting
Natalia Morone, MD
OPTIMUM aims to evaluate the impact of an innovative, group-based mindfulness program for patients with chronic low back pain in a real-life clinical setting. Mindfulness is effective for the treatment of chronic low back pain, yet remains underutilized as it has not been regularly woven into the outpatient clinical setting.
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.
Drs. Jon Tilburt and Andrea Cheville of the Mayo Clinic will present “Learning While Sprinting: A One-Year Retrospective From the NOHARM Pragmatic Trial.” The Grand Rounds session will be held on Friday, August 14, at 1:00 pm eastern. Join the online meeting.
NOHARM will test a patient- and clinician-facing clinical decision support tool embedded in the electronic health record in 4 healthcare systems. Such tools can be useful in encouraging patient-centered, guideline-concordant care, but pragmatic strategies have not been tested pragmatically in postoperative pain care.
NOHARM is supported by the NIH through the NIH HEAL Initiative under an award from the National Institute on Aging.
A co–principal investigator of the Fibromyalgia TENS in Physical Therapy Study (FM TIPS), an NIH Collaboratory Trial supported by the NIH HEAL Initiative, will be featured in the next session of NIH Collaboratory Grand Rounds on July 24. The project is the first of the NIH Collaboratory Trials funded through the Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) program to be featured in Grand Rounds.
FM TIPS will use a cluster randomized trial design to assess the feasibility of using transcutaneous electrical nerve stimulation (TENS) in addition to physical therapy for the treatment of fibromyalgia. The study will also determine whether the use of TENS improves symptoms of fibromyalgia, increases adherence to physical therapy and the likelihood of meeting therapeutic goals, and reduces medication use. FM TIPS is currently in the planning phase, which involves recruiting physical therapy sites into the embedded pragmatic clinical trial, understanding usual practice to inform trial processes, and ensuring the adequacy of trial infrastructure.
FM TIPS is supported by the NIH through the NIH HEAL Initiative under an award from the National Institute of Arthritis and Musculoskeletal and Skin Diseases.
A new chapter in the Living Textbook describes how patient-reported outcomes (PROs) are used in different settings and how to choose and integrate PRO measures into an embedded pragmatic clinical trial.
The chapter also characterizes PRO use within the PRISM program (Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing) of the NIH HEAL Initiative (Helping End Addiction Long-term Initiative). NIH Collaboratory Trials supported through the PRISM program 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
The NIH Office of Behavioral and Social Sciences Research, with other NIH Institutes, Centers, and Offices, has issued a notice of special interest calling for research on stigma in the context of chronic pain management and opioid use or opioid use disorder. The NIH will support administrative supplements to current awards and cooperative agreements under the Helping to End Addiction Long Term (HEAL) Initiative. A total of up to $3.5 million is available for the supplemental awards. Applications will be accepted through May 29, 2020.
This funding opportunity will give high priority to projects that analyze strategies to reduce stigma, discrimination, and prejudice related to chronic pain management and/or opioid use disorder; and to projects that use existing psychometrically validated tools to measure stigma (or that support the development of new measurement tools, if there is compelling rationale). Specific areas of interest include:
The impact of internalized and anticipated stigma on prevention, management, treatment, and recovery.
Prejudice by care providers that undermine treatment and health-related quality of life.
Strategies to address stigma among healthcare providers, workplace colleagues, emergency responders, family and friends, and others.
Strategies to address internalized stigma.
The adaption and application of existing theories of health-related stigma to chronic pain and/or opioid use disorder in reducing stigma.
Analyses of combinations of approaches that are known to reduce discrimination and prejudice.
Approaches to build resilience to discrimination and prejudice.
First-stage development of multicomponent approaches that could be expanded and implemented for large-scale multicomponent research projects.
The NIH Collaboratory’s Biostatistics and Study Design Core Working Group supports the Demonstration Projects by offering guidance on their statistical plans and study designs during the planning phase and documenting new statistical and methodological issues that arise during planning and implementation.
At the NIH Collaboratory PRISM kickoff meeting in November, we spoke with the leaders of the Biostatistics and Study Design Core, Dr. Patrick Heagerty and Dr. Liz Turner, to learn more about how the Core is supporting the new PRISM Demonstration Projects.
“Conducting these studies in living health systems is fraught with challenges and opportunities—things changing in the healthcare system that will affect a planned design that’s no longer possible to conduct, and building partnerships with the systems so that it’s possible to flexibly react in terms of the study design along the way,” said Dr. Turner. “We’ll be there to help support [the PRISM projects] and identify some of those challenges,” she said.
The new Demonstration Projects are part of the PRISM program (Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing), a component of the NIH’s Helping to End Addiction Long-term (HEAL) Initiative. The NIH Collaboratory serves as the PRISM Resource Coordinating Center.
“The Core group meetings bring all these amazing minds together in one spot to listen: What are we hearing that specific projects are thinking about or wrestling with?” said Dr. Heagerty. “What are ideas that we can bring to solve it? And what are new questions that we need to dig a little deeper and learn more about?” he said.
Learn more about the PRISM Demonstration Projects:
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
The NIH Collaboratory PRISM Resource Coordinating Center 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.
The NIH Collaboratory’s Electronic Health Records (EHR) Core Working Group supports the Demonstration Projects by facilitating multisite research collaborations between investigators and data stewards and by developing tools and approaches for the secondary use of EHR data for clinical research.
We spoke with the leaders of the EHR Core, Dr. Rachel Richesson and Dr. Keith Marsolo, at the NIH Collaboratory PRISM kickoff meeting in November to learn more about how the EHR Core will support the new PRISM Demonstration Projects.
“The projects have come together to look at standard approaches for measuring pain and collecting data, and if we can move the technology and the systems in a way that can make this more routine, I think that will be a great service,” said Dr. Richesson, cochair of the EHR Core.
The new Demonstration Projects are part of the the PRISM program (Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing), a component of the NIH’s Helping to End Addiction Long-term (HEAL) Initiative. The NIH Collaboratory serves as the PRISM Resource Coordinating Center.
Learn more about the PRISM Demonstration Projects:
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
The NIH Collaboratory PRISM Resource Coordinating Center 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.
The Helping to End Addiction Long-Term Initiative℠, or NIH HEAL Initiative℠, has created common data elements (CDEs) to facilitate cross-study comparisons for pain, improve interoperability of findings for patient-reported outcomes, and compare results across trials. The core CDEs were published recently in the 
The co–principal investigators of the