June 27, 2024: NIH HEAL Initiative Turns Attention to Pragmatic Trials in Rural Communities

Three of the newest NIH Collaboratory Trials are supported through the NIH HEAL Initiative℠, or Helping to End Addiction Long-Term Initiative℠, reflecting a special emphasis on developing strategies for the management of chronic pain in rural and remote populations.

“There are many known disparities between urban and rural populations,” said Karen Kehl, a program director at the National Institute of Nursing Research (NINR). “And when we talk about chronic pain, we know that there’s a higher incidence and a higher severity of pain in rural populations, and yet they don’t have access to many of the effective solutions that we have,” Kehl added.

We recently spoke with Kehl, Julie Fritz of the BeatPain Utah trial, and the principal investigators of the AIM-CP, ARBOR-Telehealth, and RAMP trials at the NIH Collaboratory’s 2024 Annual Steering Committee Meeting. They discussed the progress of their studies and the importance of supporting healthcare and promoting health equity in rural communities through pragmatic research.

AIM-CP

AIM-CP will test the implementation of a care management program to address inequities in access to nonpharmacological treatment for chronic pain in rural populations. The principal investigators are Kushang Patel and Sebastian Tong of the University of Washington. The study is supported by NINR. Learn more about AIM-CP.

ARBOR-Telehealth

ARBOR-Telehealth will evaluate the use of a telehealth physical therapy strategy for patients who present to primary care clinics with low back pain in rural communities. The principal investigators are Richard Skolasky and Kevin McLaughlin of Johns Hopkins University. The study is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Learn more about ARBOR-Telehealth.

RAMP

RAMP will evaluate the use of a 12-week mind-body skills training program for rural veterans with pain, including a one-on-one session with a “whole health coach” followed by 11 weekly group sessions to include prerecorded expert-led education videos, mind-body skills training and practice, and group discussions. The principal investigators are Diana Burgess and Roni Evans of the University of Minnesota and Katherine Hadlandsmyth of the University of Iowa. The study is supported by NINR. Learn more about RAMP.

Learn more about the NIH Collaboratory Trials.

January 16, 2024: Ethics Consultation Documents Now Available for AIM-CP and MOMs Chat & Care Study

Ethics and regulatory onboarding documentation for 2 of the NIH Pragmatic Trials Collaboratory's newest trials is now available. The documents include meeting minutes and supplementary materials summarizing recent discussions of ethics and regulatory issues associated with the AIM-CP trial and the MOMs Chat & Care Study.

The consultations took place by video conference and included representation from the studies' principal investigators, members of the NIH Collaboratory's Ethics and Regulatory Core, NIH staff, and NIH Collaboratory Coordinating Center personnel.

AIM-CP will test a care management program to address inequities in access to nonpharmacological treatment for chronic pain in rural populations.

The MOMs Chat & Care Study will test the effectiveness of an integrated care model approach at 2 levels of intensity designed to facilitate timely, appropriate care for Black patients to reduce their risk for severe maternal morbidity.

Ethics and regulatory documentation for all of the NIH Collaboratory Trials is available on our Data and Resource Sharing page.

November 1, 2023 Virtual Onboarding Meeting: iPATH, AIM-CP, I CAN DO Surgical ACP, MOMS, RAMP, and ARBOR-Telehealth

NIH Pragmatic Trials Collaboratory Onboarding Meeting

November 1, 2023
Virtual

Purpose

Welcome the new UG3 and R01 NIH Collaboratory Trials; provide introductions and an overview of the NIH Collaboratory program; hear from the new UG3 and R01 project teams; and discuss lessons learned from the seasoned NIH Collaboratory Trial investigators.

Welcome and Opening Remarks
Wendy Weber, ND, PhD, MPH
Lesley Curtis, PhD

Overview of the NIH Pragmatic Trials Collaboratory and a Cooperative Agreement
Beda Jean-Francois, PhD

NIH Collaboratory Coordinating Center: Overview and Goals
Lesley Curtis, PhD

Program Policies and Guidance Documents
Rich Platt, MD, MSc
Gina Uhlenbrauck

Discussion of New NIH Collaboratory Trials

  • iPATH
    Sara Singer, PhD, MBA
  • AIM-CP
    Sebastian Tong, MD, MPH
    Kushang Patel, Phd, MPH
  • MOMs
    Stephanie Fitzpatrick, PhD
  • RAMP
    Diana Burgess, PhD
    Roni Evans, DC, MS, PhD
    Katherine Hadlandsmyth, PhD

Lessons Learned From Seasoned NIH Collaboratory Trials
Moderator: Lesley Curtis, PhD

Panel:

  • Lynn Debar, PhD
  • Angelo Volandes, MD, MPH
  • Susan Huang, MD, MPH
  • Michael Ho, MD, PhD
  • Kathleen Sluka, PT, PhD
  • Andrea Cheville, MD

Closing Remarks
Beda Jean-Francois, PhD
Lesley Curtis, PhD

October 31, 2023: NIH Pragmatic Trials Collaboratory Welcomes 5 New NIH Collaboratory Trials

The NIH Pragmatic Trials Collaboratory is excited to announce the addition of 5 new large-scale pragmatic clinical trials to its portfolio of innovative NIH Collaboratory Trials, which will extend the program's mission to strengthen the national capacity to implement cost-effective, large-scale research studies that engage healthcare delivery organizations as research partners.

Three of the new 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.

  • Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth Intervention (RAMP) is a pragmatic trial that will address the challenge of implementing effective, non-opioid interventions for chronic pain management in rural and remote dwelling veteran populations by developing an innovative telehealth evidence-based intervention to address veterans' biophysical, psychological, and social needs. The study is administered by the National Institute of Nursing Research and will be conducted by Diana Burgess of the Minneapolis Veterans Affairs Healthcare System, Roni Evans of the University of Minnesota, and Katherine Hadlandsmyth of the University of Iowa.
  • Advancing Rural Back Pain Outcomes through Rehabilitation Telehealth (ARBOR-Telehealth) is a pragmatic trial that seeks to understand the effectiveness of telerehabilitation as a method of improving access to physical therapy for patients with chronic lower back pain living in rural communities and improving outcomes of these patients. The study is administered by the National Institute of Arthritis and Musculoskeletal and Skin Diseases and will be conducted by Richard Skolasky Jr and Kevin McLaughlin of Johns Hopkins University.
  • Adapting and Implementing a Nurse Care Management Model to Care for Rural Patients with Chronic Pain (AIM-CP) is a pragmatic trial that seeks to address chronic pain outcomes for individuals living in rural communities by adapting, piloting, and implementing a nurse care management model to test its effectiveness as a nonpharmacologic treatment option. The study is administered by the National Institute of Nursing Research and will be conducted by Sebastian Tong and Kushang Patel of the University of Washington.

The NIH Pragmatic Trials Collaboratory is also adding 2 projects supported by grants from the National Institute of Nursing Research and the National Institute on Minority Health and Health Disparities.

These new NIH Collaboratory Trials join the 4 other trials added to the NIH Pragmatic Trials Collaboratory portfolio in 2023, which include BEST-ICU, Chat 4 Heart Health, I CAN DO Surgical ACP, and TAICHIKNEE.