Notice of Intent to Publish a Funding Opportunity Announcement for Integrated Approach to Pain and Opioid Use in Hemodialysis Patients Scientific and Data Research Center (U01 Clinical Trial Required)

Notice Number: NOT-DK-19-002

Key Dates

Release Date:October 12, 2018
Estimated Publication Date of Funding Opportunity Announcement: December 01, 2018
First Estimated Application Due Date: March 27, 2019
Earliest Estimated Award Date: September 17, 2019
Earliest Estimated Start Date: December 01, 2019

Related Announcements
NOT-DK-19-001

Issued by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Purpose

The National Institute of Diabetes and Digestive Diseases and Kidney Diseases (NIDDK), intends to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications for research on pain and opioid use in hemodialysis patients.

Medicare’s End-Stage Renal Disease (ESRD) program covers healthcare costs for the more than 600,000 Americans with kidney failure, almost 500,000 of whom are treated by hemodialysis (HD). ESRD is characterized by racial disparities and high prevalence of comorbidities (such as diabetes, depression, and anxiety). Pain is a common problem in HD patients, but its prevalence varies widely by geography, dialysis unit, and, possibly, ethnicity. Pain has been linked to decreased quality of life, lack of social support, depressed mood and other mental health disorders. Chronic opioid prescription has been identified in approximately 20% of US ESRD HD patients, far higher than in Medicare comparison populations. Opioid doses prescribed to HD patients exceed Center for Disease Control (CDC) recommendations. Prescription and dose level have been associated with increased hospitalizations and mortality in this population.

Interventions including behavioral modification techniques — such as Cognitive Behavioral/Group Therapy – and social media platforms for sharing information and enhancing social support have not been employed to reduce the rate of opioid prescription and  opioid use,  as well as addressing co-morbid related issues such as mental health, depression and pain in the HD population. In addition, medical interventions such as use of naloxone and buprenorphine have not been evaluated by randomized controlled trials in HD patients who use opioids. The ESRD population, because of its continuous longitudinal participation in monitored treatment and the availability of data resources is an ideal population in which to launch and monitor interventions, including pragmatic trials. 

A consortium composed of a Scientific and Data Research Center (SDRC) and several Clinical Centers (CCs) will develop trials to simultaneously address the problem of pain and opioid use in US HD populations receiving chronic opioid prescriptions by a) initiating multi-pronged pain treatment tailored individually to each patient, without opioids, and b) using buprenorphine and other novel agents to reduce dependence on opioids in affected patients. Multi-pronged interventions will include behavioral modification techniques—such as Cognitive Behavioral/Group Therapy, which can be designed according to each participants’ psychosocial profile, as well as alternative therapies, such as acupuncture — and can use social media platforms for implementation and evaluation. Analyses will consider co-morbid illnesses (e.g., diabetes, mental health disorders) and social determinants of health (e.g., socioeconomic status, social isolation, social support, racial discrimination) to identify novel risk factors for pain and opioid use in this population. End points will be opioid medication prescription rates, pain control, patient satisfaction with care, quality of life, hospitalization rates, and mortality. Real time risk factor and outcomes data may be captured via the electronic health record (EHR), by leveraging and expanding an existing, pilot set of more than 200 standardized data elements identified and prioritized for comprehensive chronic kidney disease (CKD) care by the NIDDK CKD eCare Plan Working Group.

Research Initiative Details

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 November 2018 with an expected application due date in March 2019.

 This FOA will utilize the U01 activity code. Details of the planned FOA are provided below.

Funding Information

Estimated Total Funding NIDDK intends to commit $750,000 to the entire Program in FY 2019.
Expected Number of Awards The expected number of awards for the SDRC is 1 in FY 2019.
Estimated Award Ceiling The Estimated Award Ceiling is $500,000 Direct Costs per year.
Primary CFDA Numbers 93.847

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)
Nonprofit without 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)
County governments
City or township governments
Special district governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Regional Organization

Applications are not being solicited at this time.

Inquiries

Please direct all inquiries to:

Paul L. Kimmel, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
301-594-1409
paul.kimmel@nih.gov