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) – Scholarship and Grants Opportunities

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Opportunity ID: 310196
Opportunity Number: NOT-DK-19-002
Opportunity Title: 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)
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Cooperative Agreement
Category of Funding Activity: Health
Category Explanation:
CFDA Number(s): 93.847
Eligible Applicants: State governments
County governments
City or township governments
Special district governments
Independent school districts
Public and State controlled institutions of higher education
Native American tribal governments (Federally recognized)
Public housing authorities/Indian housing authorities
Native American tribal organizations (other than Federally recognized tribal governments)
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Private institutions of higher education
For profit organizations other than small businesses
Small businesses
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Additional Information on Eligibility:
Agency Code: HHS-NIH11
Agency Name: Department of Health and Human Services
National Institutes of Health
Posted Date: Nov 05, 2018
Estimated Synopsis Post Date: Dec 01, 2018
Fiscal Year: 2019
Award Ceiling: $500,000
Award Floor:
Estimated Total Program Funding: $750,000
Expected Number of Awards: 1
Description: 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.
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