OPTIMUM

December 14, 2021: A Year of New Insights From the NIH Collaboratory

Posted on by Damon Seils

Collage of journal coversNIH Collaboratory researchers in 2021 shared study results, generated new knowledge, and developed innovative research methods in pragmatic clinical trials. Their work included insights from the Coordinating Center and Core Working Groups, analyses from the NIH Collaboratory Distributed Research Network, and results and methodological approaches from the NIH Collaboratory Trials.

So far this year, the NIH Collaboratory has produced 3 dozen articles in the peer-reviewed literature, including the primary results of the PPACT and TSOS trials, the study design of the Nudge and OPTIMUM studies, insights into the COVID-19 pandemic from the EMBED and ACP PEACE studies, and more:

NIH Collaboratory Coordinating Center

NIH Collaboratory Distributed Research Network

ACP PEACE NIH Collaboratory Trial

BackInAction NIH Collaboratory Trial

EMBED NIH Collaboratory Trial

GRACE NIH Collaboratory Trial

HiLo NIH Collaboratory Trial

LIRE NIH Collaboratory Trial

Nudge NIH Collaboratory Trial

OPTIMUM NIH Collaboratory Trial

PPACT NIH Collaboratory Trial

PRIM-ER NIH Collaboratory Trial

PROVEN NIH Collaboratory Trial

SPOT NIH Collaboratory Trial

TSOS NIH Collaboratory Trials

July 27, 2021: Diversity Workshop Continues With Diversifying the Pipeline of PCT Investigators and Leaders

Posted on by Damon Seils

The NIH Collaboratory is using its popular ePCT Grand Rounds platform for a special webinar series on diversity in pragmatic clinical trials.

In this Friday’s session—“Diversity in the PCT Ecosystem – How Do We Develop a Pipeline of Diverse Investigators and Leaders in PCTs?”—Dr. Lesley Curtis, co–principal investigator of the NIH Collaboratory Coordinating Center, will host a panel of investigators for a discussion about strategies for developing a diverse pipeline of researchers and leaders in the field of pragmatic clinical research.

The panelists will include:

  • Dr. Marie Bernard, deputy director of the National Institute on Aging and acting NIH chief officer for scientific workforce diversity
  • Dr. George Mensah of the Center for Translation Research and Implementation Science at the National Heart, Lung, and Blood Institute
  • Dr. Natalia Morone of Boston University, principal investigator of OPTIMUM, an NIH Collaboratory Trial

The Grand Rounds session will be held on Friday, July 30, at 1:00 pm eastern. Join the online meeting.

The complete diversity workshop series includes:

All sessions are free and open to the public; no registration is required. Recordings will be archived on the Grand Rounds website.

 

Headshots of Lesley Curtis, Marie Bernard, George Mensah, and Natalia Morone
Left to right: Dr. Lesley Curtis, Dr. Marie Bernard, Dr. George Mensah, and Dr. Natalia Morone

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.

Grand Rounds Diversity Workshop Series July 30: Inclusion of Diverse Participants in Pragmatic Clinical Trials: Diversity in the PCT Ecosystem – How Do We Develop a Pipeline of Diverse Investigators and Leaders in PCTs?

Guest Moderator:
Lesley Curtis, PhD
Professor in Population Health Sciences
Department of Population Health Sciences
Duke University School of Medicine

Panel:
Marie A. Bernard, MD
Acting NIH Chief Officer for Scientific Workforce Diversity
Deputy Director, National Institute on Aging
National Institutes of Health

George A. Mensah, M.D., FACC
Director, Center for Translation Research and Implementation Science
National Heart, Lung, and Blood Institute (NHLBI)
Office of the Director, National Institutes of Health (NIH)

Natalia Morone, MD, MS
Associate Professor
Boston University School of Medicine
Department of Medicine
General Internal Medicine

Topic: Inclusion of Diverse Participants in Pragmatic Clinical Trials: Diversity in the PCT Ecosystem – How Do We Develop a Pipeline of Diverse Investigators and Leaders in PCTs?
Date: Friday, July 30, 2021, 1:00-2:00 p.m. ET

Meeting Info: To check whether you have the appropriate players installed for UCF (Universal Communications Format) rich media files, go to https://dukemed.webex.com/dukemed/systemdiagnosis.php.

To join the online meeting:
Go to https://dukemed.webex.com/dukemed/j.php?MTID=m228b52a4666c1e24046e11c01ae7bd0d

You must log in to the URL first.
Click ‘Audio Conference’
Choose ‘I will call in’, select the Toll number.
Dial in using the information from the dialog box that appears.
Be certain to use the Access Code AND the Attendee ID.

Troubleshooting:
If the URL above does not work, go to dukemed.webex.com and enter:
Meeting Number: 120 909 9614
Meeting Password: 1234

For Audio ONLY:
Call-in toll number (US/Canada): 1-650-479-3207
Access code: 120 909 9614

NOTE: For Toll-free users, the call-back (call me) services are also available.

February 8, 2021: Meeting Minutes are Available from the Ethics and Regulatory Core Discussions with the PRISM NIH Collaboratory Trials

Posted on by Gina Uhlenbrauck

Meeting minutes, supplementary materials, and updates are available that summarize recent discussions related to the ethics and regulatory issues associated with the six 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.

October 6, 2020: Four PRISM NIH Collaboratory Trials Awarded Continuation From Planning to Implementation Phase

Posted on by Gina Uhlenbrauck

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, MPH
Photo of Lynn DeBar, principal investigator of PPACT
Lynn 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, PhD
Leslie 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

Photo of Andrea Cheville, co–principal investigator of NOHARM
Andrea Cheville, MD
Jon 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.

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

Posted on by Karen Staman

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 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.

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

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.