GRACE

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.

November 9, 2020 Virtual Onboarding Meeting: BeatPain Utah and GRACE

PRISM Onboarding Meeting

November 9, 2020
Virtual

Main Purpose

Welcome the new PRISM UG3 NIH Collaboratory Trials; provide introductions, an overview of the Collaboratory Program and the NIH HEAL Initiative, hear from the new UG3 PRISM Projects; and discuss lessons learned from the Collaboratory Projects.

Welcome and Opening Remarks
Helene Langevin, MD, CM; 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

Discussion From New UG3 NIH Collaboratory Trials

  • GRACE
    Ardith Z. Doorenbos, PhD, RN; Robert E. Molokie, MD; Judith M. Schlaeger, PhD, CNM; Miriam O. Ezenwa, PhD, RN; Nirmish Shah, MD

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

Panel:
Jerry Jarvik, MD, MPH; Doug Zatzick, MD; Miguel Vazquez, MD; Mike Ho, MD, PhD; Karen Sherman, PhD, MPH; Natalia Morone, MD

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

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.