Grand Rounds August 14: Learning While Sprinting: A One-Year Retrospective from the NOHARM Pragmatic Trial

Speakers:

Jon Tilburt, MD
Professor of Medicine and Biomedical Ethics
Mayo Clinic

Andrea Cheville, MD
Professor of Physical Medicine and Rehabilitation
Mayo Clinic

Topic: Learning While Sprinting: A One-Year Retrospective from the NOHARM Pragmatic Trial
Date: Friday, August 14, 2020, 1:00-2:00 p.m. ET

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June 4, 2020: New Chapter in the Living Textbook Describes the Uses and How-tos of Patient-Reported Outcomes

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 main topics of the chapter are:

The authors also include Core Outcome Sets for chronic pain, low back pain, musculoskeletal pain, and cancer.

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

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.

November 2019 Onboarding Meeting: NOHARM, OPTIMUM, FM TIPS, and AcuOA

PRISM Onboarding Meeting

November 19-20, 2019
Bethesda, MD

Main Purpose

To welcome the PRISM UG3 NIH Collaboratory Trials; provide introductions, an overview of the Collaboratory, and
an understanding of the Core Working Groups; and discuss lessons learned from the Collaboratory.

Tuesday, November 19, 2019

Welcome and Opening Remarks
Helene Langevin, MD, PhD; Richard Hodes, MD; Lesley Curtis, PhD

Introduction of the New Study Teams, NIH Program Staff, and Coordinating Center Core Work
Groups
Helene Langevin, MD, PhD; Richard Hodes, MD; Lesley Curtis, PhD

Overview of the NIH HCS Research Collaboratory Program
Cathy Meyers, MD

HEAL Initiative Overview
Rebecca Baker, PhD

Overview of a HEAL Cooperative Agreement
Wendy Weber, ND, PhD, MPH; Laura Wandner, PhD

Collaboratory Coordinating Center Overview and Goals
Adrian Hernandez, MD, MHS

CMS and the NIH Collaboratory
Joseph Chin, MD, MS

ClinicalTrials.gov Registration and Reporting
Stacey Arnold, PhD

Discussion From New UG3 NIH Collaboratory Trials

  • NOHARM
    Andrea Cheville, MD; Jon Tilburt, MD
  • FM TIPS
    Kathleen Sluka, PT, PhD; Leslie Crofford, MD
  • AcuOA
    Lynn DeBar, PhD, MPH; Karen J Sherman, PhD, MPH

Lessons Learned from Seasoned NIH Collaboratory Trials
Lesley Curtis, PhD; Ted Melnick, MD, MHS; Jerry Jarvik, MD, MPH; Vincent Mor, PhD; Doug Zatzick, MD; Miguel Vazquez, MD

Closing Remarks
Helene Langevin, MD, PhD; Richard Hodes, MD; Lesley Curtis, PhD

 

Wednesday, November 20, 2019

Welcome and Opening Remarks
Helene Langevin, MD, PhD; Richard Hodes, MD; Lesley Curtis, PhD

Breakout Sessions

Debrief for Breakout Sessions
Adrian Hernandez, MD, MHS; Patrick Heagerty, PhD; Leah Tuzzio, MPH; Rachel Richesson, PhD, MPH; Kevin Weinfurt, PhD; Lesley Curtis, PhD

Closing Remarks/Adjourn
Helene Langevin, MD, PhD; Richard Hodes, MD; Lesley Curtis, PhD

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

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.