Notice of Intent to Publish a Funding Opportunity Announcement Re-issuance for HEAL Initiative: Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) (UG3/UH3, Clinical Trials Optional)

Notice Number: NOT-AT-20-005

Key Dates

Release Date: December 13, 2019
Estimated Publication Date of Funding Opportunity Announcement: January 30, 2020
First Estimated Application Due Date: March 30, 2020
Earliest Estimated Award Date: September 01, 2020
Earliest Estimated Start Date: September 01, 2020

Related Announcements
RFA-AT-19-004

Issued by
National Center for Complementary and Integrative Health (NCCIH)

National Center for Advancing Translational Sciences (NCATS)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Behavioral and Social Sciences Research (OBSSR)

Purpose

The National Center for Complementary and Integrative Health (NCCIH), with other NIH Institutes, Centers, and Offices (ICOs), intends to publish a re-issuance of Funding Opportunity Announcement (FOA) RFA-AT-19-004 to solicit applications for phased cooperative research applications to conduct efficient, large-scale pragmatic or implementation trials to improve pain management and reduce the unnecessary use of opioid medications in the health care delivery setting.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

The FOA is expected to be published in January 2020 with an expected application due date in March 2020.

This FOA will utilize the UG3/UH3 activity code. Details of the planned FOA are provided below.

Research Initiative Details

This Notice encourages investigators with expertise and insights in the area of pragmatic trials to improve pain management to consider applying for this reissued FOA.

More than 25 million Americans suffer from chronic pain, a highly debilitating medical condition that is complex and difficult to manage. In recent decades, there has been an overreliance on the prescription of opioids for chronic pain, contributing to a significant and alarming epidemic of opioid overdose deaths and addiction. Most chronic pain management is delivered in primary care settings, where providers may not have tools to implement the few evidence-based pain management guidelines to support their clinical decisions. Acute pain management often is delivered in emergency departments, hospital settings, or dental clinics, where reliance on treatment with opioids increases risks of Opioid Use Disorder (OUD). Adults with pain due to injury, neck and back pain, abdominal pain, or headache make up over 33 million Emergency Room (ER) visits per year. Analgesics are the medications most prescribed from outpatient office visits. Pragmatic trials and implementation studies are needed because policies, clinical practice guidelines, and tools and interventions to improve pain management have not been readily adopted and implemented by health care systems. Research is needed to study strategies to most effectively, equitably, and efficiently implement evidence-based interventions and pain management guidelines.

This reissuance of "HEAL Initiative: Pragmatic and Implementation Studies for the Management of Pain To Reduce Opioid Prescribing (PRISM) (UG3/UH3 Clinical Trial Optional)” will prioritize the following areas for pragmatic trials to integrate multimodal or multiple interventions that have demonstrated efficacy into health care systems or implement health care system changes to improve adherence to evidence-based guidelines. Trials or studies should be conducted across three or more health care systems (HCS) and will become part of and work with the NIH HCS Research Collaboratory supported through the NIH Common Fund. (See https://commonfund.nih.gov/hcscollaboratory.) Results from the pragmatic trials supported by this reissue should inform policy makers, payers, health care providers, and patients in the primary care, emergency department, hospital, or dental setting. The areas of high priority are:

  • Pain management in emergency departments, dental clinics, primary care, and hospitals
  • Chronic overlapping pain conditions
  • Pain management in individuals at risk of or with OUD
  • Pain management in those with co-occurring mental health disorders
  • Noncancer pain management in persons with medical comorbidities

Funding Information

Estimated Total Funding The HEAL Initiative intends to commit $1,200,000 total costs for FY2020
Expected Number of Awards Up to 2 awards
Estimated Award Ceiling The maximum amount per award to be funded or awarded annually. The application budget for the UG3 phase is limited to $500,000/year in direct costs. Direct costs for each year of the UH3 phase are limited to $1 million/year . The UG3 phase is limited to up to one year and the UH3 phase can request up to 4years of support. The total project period for an application submitted in response to this FOA may not exceed 5 years
Primary CFDA Numbers93.213, 93.350

Anticipated Eligible Organizations

Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
Eligible Agencies of the Federal Government
Applications are not being solicited at this time. 

 

Inquiries

Please direct all inquiries to:

Wendy Weber, N.D., Ph.D., M.P.H.
National Center for Complementary and Integrative Health (NCCIH)
301-402-1272
weberwj@mail.nih.gov

HEAL Inquires

National Center for Complementary & Integrative Health (NCCIH) National Institutes of Healt
Email: NCCIHHEAL@mail.nih.gov