OPTIMUM Archives - Rethinking Clinical Trials (2024)

Table of Contents
July 19, 2022: Three PRISM NIH Collaboratory Trials Share Latest Updates and Accomplishments March 25, 2022: A Telehealth-Delivered Pragmatic Trial of Mindfulness for Persons with Chronic Low Back Pain (Natalia Morone, MD, MS) Speaker Keywords Key Points Discussion Themes March 23, 2022: OPTIMUM Pragmatic Trial Will Be Featured in PCT Grand Rounds December 14, 2021: A Year of New Insights From the NIH Collaboratory 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 May 11, 2021: OPTIMUM Begins Enrollment in Group-Based Mindfulness Intervention for Low Back Pain 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? February 8, 2021: Meeting Minutes are Available from the Ethics and Regulatory Core Discussions with the PRISM NIH Collaboratory Trials October 6, 2020: Four PRISM NIH Collaboratory Trials Awarded Continuation From Planning to Implementation Phase June 4, 2020: New Chapter in the Living Textbook Describes the Uses and How-tos of Patient-Reported Outcomes

July 19, 2022: Three PRISM NIH Collaboratory Trials Share Latest Updates and Accomplishments

Posted on July 19, 2022January 16, 2024 by Damon Seils

At the NIH Pragmatic Trials Collaboratory’s annual Steering Committee meeting this spring, we interviewed investigators from 3 of the PRISM NIH Collaboratory Trials to discuss their progress in the first year of study implementation. All of the studies began enrollment last year.

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 PRISM NIH Collaboratory Trials 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.

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 are 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 is being conducted by Dr. Julie Fritz of the University of Utah. Learn more about BeatPain Utah.

The 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 is being conducted by Drs. Ardith Doorenbos, Judith Schlaeger, Robert Molokie, and Miriam Ezenwa of the University of Illinois Chicago and Dr. Nirmish Shah of Duke University. Learn more about GRACE.

OPTIMUM is evaluating the impact of an innovative, group-based mindfulness program for patients with chronic low back pain in real-world clinical settings. Mindfulness is effective for the treatment of chronic low back pain but remains underutilized as it has not been regularly woven into outpatient clinical settings. The study is administered by National Center for Complementary and Integrative Health and is being conducted by Dr. Natalia Morone of Boston University and Boston Medical Center. Learn more about OPTIMUM.

See also our recent interviews with the principal investigators of our other PRISM NIH Collaboratory Trials:

  • BackInAction
  • FM-TIPS
  • NOHARM

OPTIMUM Archives - Rethinking Clinical Trials (1)

March 25, 2022: A Telehealth-Delivered Pragmatic Trial of Mindfulness for Persons with Chronic Low Back Pain (Natalia Morone, MD, MS)

Posted on March 28, 2022March 31, 2022 by terren.green@duke.edu

Speaker

Natalia E. Morone, MD, MS
Associate Professor of Medicine
Boston University/Boston Medical Center

Keywords

Chronic pain; Mindfulness; Stress Reduction; Low back pain; OPTIMUM; The Pain, Enjoyment of Life and General Activity (PEG) Scale; HEAL Initiative

Key Points

  • Chronic back pain is very common across all racial and ethnic groups. Doctors treat chronic back pain with non-pharmacologic methods before resorting to pharmacologic treatments.
  • Optimizing Pain Treatment in Medical Settings Using Mindfulness (OPTIMUM) is a randomized study of mindfulness for low back pain operating in 3 health settings: Boston Medical Center; UPMC, Pittsburgh, PA; and University of North Carolina, Chapel Hill in partnership with Piedmont Health Services.
  • Participation in the OPTIMUM study requires 8 weekly 90 minute group-based sessions of mindfulness meditation training delivered in primary care through a telehealth medical visit with follow up assessments at 6 and 12 months.
  • Four methods of mindfulness meditation are taught: Walking meditation, body scan, breath focused meditation, and mindful stretching.
  • The OPTIMUM study uses the PEG scale as the main outcome measure at the 6 and 12 month follow up assessments.
  • Group tele-health visits provide a variety of benefits for patients including more time with a clinician, better medication adherence, and more patient satisfaction.

Discussion Themes

Primary care usually consists of 1 provider and 1 patient, but family medicine evolved to see patients in a group. This group setting model may have unexpected benefits.

OPTIMUM is part of the PRISM project and is collecting data on participant use of opioids along with all PRISM projects.

Recruiting minority participants has been a priority in the OPTIMUM trial. Targeting recruitment advertisem*nts to zip codes where more minorities live makes a difference in recruiting a diverse population.

Read more about the OPTIMUM trial.

Tags

#pctGR, @Collaboratory1

March 23, 2022: OPTIMUM Pragmatic Trial Will Be Featured in PCT Grand Rounds

Posted on March 23, 2022January 16, 2024 by Damon Seils

OPTIMUM Archives - Rethinking Clinical Trials (2)

In this Friday’s PCT Grand Rounds, Dr. Natalia Morone of Boston University and Boston Medical Center will present “A Telehealth-Delivered Pragmatic Trial of Mindfulness for Persons With Chronic Low Back Pain.” The Grand Rounds session will be held on Friday, March 25, at 1:00 pm eastern.

Mindfulness-based stress reduction is now recommended by the American College of Physicians for initial treatment of chronic low back pain. The primary goal of OPTIMUM, an NIH Pragmatic Trials Collaboratory Trial, is to determine the impact of a group-based mindfulness intervention under usual care circ*mstances.

Join the online meeting.

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

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

Posted on December 14, 2021January 16, 2024 by Damon Seils

OPTIMUM Archives - Rethinking Clinical Trials (3)NIH 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 July 27, 2021January 16, 2024 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:

  • June 4, 2021, 1:00 pm ET: Planning for Diversity: Stakeholder Engagement and Site Selection to Maximize Diversity (Gloria Coronado, PhD; Julie Fritz, PhD, PT; Amanda Petrik, MS; David Wetter, PhD, MS; Moderator: Wendy Weber, ND, PhD, MPH)
  • June 25, 2021, 1:00 pm ET: Meeting Participants Where They Are: Outreach, Trust, and Consent to Maximize Diversity (Jonathan Jackson, PhD; Judith Schlaeger, PhD, CNM, LAc, FAAN; Stacy Sterling, DrPH, MSW, MPH; Moderator: Emily O’Brien, PhD)
  • July 16, 2021, 1:00 pm ET: Maximizing Diversity in PCTs: What Can We Learn From Implementation Trials? (Amanda Midboe, PhD; Anne Trontell, MD, MPS; Moderator: David Chambers, DPhil)
  • July 30, 2021, 1:00 pm ET: Diversity in the PCT Ecosystem: How Do We Develop a Pipeline of Diverse Investigators and Leaders in PCTs? (Marie Bernard, MD; George Mensah, MD; Natalia Morone, MD, MS; Moderator: Lesley Curtis, PhD)
  • Podcast available August 9, 2021: Summary Expert Panel Discussion (David Chambers, DPhil; Lesley Curtis, PhD; Emily O’Brien, PhD; Wendy Weber, ND, PhD, MP; Kanecia Zimmerman, MD; Moderator: Robin Boineau, MD, MA)

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

OPTIMUM Archives - Rethinking Clinical Trials (4)

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

Posted on May 11, 2021 by Damon Seils

OPTIMUM Archives - Rethinking Clinical Trials (5)

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 February 8, 2021January 16, 2024 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:

  • In the UG3 planning phase, the trials include BeatPain Utah and GRACE
  • In the UH3 implementation phase, the trials include BackInAction, FM TIPS, NOHARM, and OPTIMUM

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 October 6, 2020January 16, 2024 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

OPTIMUM Archives - Rethinking Clinical Trials (6)
OPTIMUM Archives - Rethinking Clinical Trials (7)

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

OPTIMUM Archives - Rethinking Clinical Trials (8)
OPTIMUM Archives - Rethinking Clinical Trials (9)

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

OPTIMUM Archives - Rethinking Clinical Trials (10)
OPTIMUM Archives - Rethinking Clinical Trials (11)

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

OPTIMUM Archives - Rethinking Clinical Trials (12)

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 June 4, 2020January 17, 2024 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:

  • Introduction
  • How are PRO Measures Used?
  • Choosing PRO Measures
  • Incorporating PRO Data into the Electronic Health Record (EHR)
  • Cultural Adaptation and Linguistic Translation
  • Additional Resources

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

OPTIMUM Archives - Rethinking Clinical Trials (2024)
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