PRISM

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

May 13, 2021: NIH HEAL Initiative Seeking Feedback Through Online Idea Exchange

Posted on by Damon Seils

Logo for the NIH HEAL InitiativeThe Helping to End Addiction Long-Term Initiative℠, or NIH HEAL Initiative℠, has launched an online communication and collaboration space, the Moving HEAL Research into Action Idea Exchange, to collect information that will shape the future of the initiative’s research on pain and addiction. Researchers, healthcare providers, and other stakeholders in the opioid crisis are encouraged to register for free and submit ideas to the exchange by June 1.

Information collected in the idea exchange will help the NIH HEAL Initiative identify research information that is important to stakeholders in the pain and opioid misuse communities and guide the initiative on how to share the results of research most effectively.

One component of the NIH HEAL Initiative is the PRISM program—Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing. Six PRISM Demonstration Projects 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. The NIH Collaboratory Coordinating Center serves as the PRISM Resource Coordinating Center.

May 11, 2021: OPTIMUM Begins Enrollment in Group-Based Mindfulness Intervention for Low Back Pain

Posted on by Damon Seils
Dr. Natalia Morone
Dr. Natalia Morone

The Group-Based Mindfulness for Patients With Chronic Low Back Pain in the Primary Care Setting (OPTIMUM) trial has begun enrollment of study participants. The trial is part of the first cohort of the NIH Collaboratory’s Demonstration Projects to be supported through the NIH Heal Initiative’s PRISM program.

Congratulations to principal investigator Dr. Natalia Morone and the OPTIMUM team!

OPTIMUM is a pragmatic clinical trial integrating a group-based mindfulness stress reduction program into primary care settings for patients with chronic low back pain. The study will randomly assign 450 patients in 3 healthcare systems to either the group-based mindfulness intervention or usual care. The aim of the study is to integrate the program into primary care clinics and measure its effectiveness in reducing chronic low back pain, improving physical and psychological function, and reducing or stopping opioid prescriptions.

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.

Learn more about OPTIMUM in this interview with Dr. Morone.

OPTIMUM is supported by the NIH through the NIH HEAL Initiative under an award from the National Center for Complementary and Integrative Health.

April 27, 2021: NOHARM Trial Enrolls First Participants in Study of Postoperative Pain Care

Posted on by Damon Seils
Photographs of Dr. Andrea Cheville on the left and Dr. Jon Tilburt on the right.
Dr. Andrea Cheville (left) and Dr. Jon Tilburt (right)

The Nonpharmacologic Options in Postoperative Hospital-Based and Rehabilitation Pain Management (NOHARM) trial has begun enrollment of study participants. The trial is among the first of the NIH Collaboratory’s Demonstration Projects to be supported through the NIH Heal Initiative’s PRISM program.

Congratulations to co–principal investigators Drs. Andrea Cheville and Jon Tilburt and the NOHARM team!

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.

NOHARM is a stepped-wedge, cluster randomized pragmatic trial testing a bundled intervention comprised of patient- and clinician-facing decision support embedded in the electronic health record (EHR). The purpose of the intervention is to elicit preferences for, document, and direct patients toward evidence-based nonpharmacologic postoperative pain care. The trial will enroll up to 140,000 patients in surgical practices in 4 healthcare systems to evaluate whether pain and function, assessed with PROMIS tools, can be improved while honoring patient values and deemphasizing opioids in pain management.

During the 1-year planning phase, the study team recruited study sites and assessed the feasibility of the EHR-embedded bundle of decision support components. Learn more about NOHARM in this interview with Dr. Cheville.

NOHARM is supported by the NIH through the NIH HEAL Initiative under an award from the National Institute on Aging.

April 22, 2021: Materials From the NIH Collaboratory Steering Committee’s Virtual Meeting Now Available

Posted on by Gina Uhlenbrauck

On April 14 and 15, 2021, more than 100 participants joined the online Steering Committee meeting to discuss important considerations for Collaboratory trials and the embedded pragmatic clinical trial ecosystem at large, including adaptations made due to COVID-19, data sharing models and experiences, barriers encountered, and lessons learned. All presentations are available for download.

March 18, 2021: FM-TIPS Becomes First PRISM NIH Collaboratory Trial to Begin Enrollment

Posted on by Damon Seils
Still image from a video interview of Drs. Kathleen Sluka on the left and Leslie Crofford on the right
Dr. Kathleen Sluka (left) and Dr. Leslie Crofford (right)

The Fibromyalgia TENS in Physical Therapy Study (FM-TIPS) has begun enrollment of study participants. It is the first study supported through the NIH Heal Initiative’s PRISM program to begin enrollment.

Congratulations to co–principal investigators Drs. Kathleen Sluka and Leslie Crofford and the FM-TIPS team!

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.

FM-TIPS is using 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.

During the 1-year planning phase, the study team recruited physical therapy sites into the trial, established a better understanding of usual practice to inform trial processes, and ensured the adequacy of trial infrastructure. Learn more about FM-TIPS in this interview with Drs. Sluka and Crofford.

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.

March 17, 2021: Cultural and Linguistic Adaptations: Results of a Survey of PRISM NIH Collaboratory Trials

Posted on by Karen Staman

To better understand efforts at cultural and linguistic adaptions in clinical trials focused on pain, members of the NIH Collaboratory’s Patient-Centered Outcomes Core recently conducted a survey of the PRISM NIH Collaboratory Trials (Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing), which are part of NIH’s Helping to End Addiction Long-term Initiative℠, or NIH HEAL Initiative℠.

"Having culturally valid patient-reported outcome instruments is extremely important to the conduct of embedded pragmatic trials. For the results to be valid, the intended audience needs to understand both the measure and what is being asked of them. This is critical for trials centered on pain because pain-related outcomes are best described by the person who is experiencing the symptoms."  —Emily O’Brien, PhD, Co-Chair of the Patient-Centered Outcomes Core

The results are published in the Cultural Adaptation and Linguistic Translation section of the Patient-Reported Outcomes Chapter in the Living Textbook.
For more information on the PRISM projects, 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

Note that the 2 newest PRISM projects, GRACE and BeatPain Utah, are still in the design phase and were not included in this round of interviews.

January 11, 2021: Study Snapshots for Four PRISM UH3 NIH Collaboratory Trials Are Available

Posted on by Gina Uhlenbrauck

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

November 5, 2020: NIH HEAL Initiative Common Data Elements Published in the Living Textbook

Posted on by Karen Staman

Logo for the NIH HEAL InitiativeThe 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.”

      —Emily O’Brien, PhD, co–principal investigator of the NIH Collaboratory Patient-Centered Outcomes Core

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.

Learn more in the Choosing PRO Measures chapter of the Living Textbook.

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.