Integrated Approach to Pain and Opioid Use in Hemodialysis Patients
The Research Need
Pain is a common problem in Medicare end-stage renal disease (ESRD) hemodialysis patients. The rate of chronic opioid prescriptions in ESRD hemodialysis patients, approximately 20 percent, is higher than the rate in Medicare comparison populations.
ESRD hemodialysis patients are an ideal population in which to launch and monitor interventions because of their long-term participation in monitored treatment and the availability of data resources. To date, many interventions, both behavioral and medical, have not been tried in this population or have not been rigorously evaluated by randomized controlled trials. These interventions could reduce the rate of opioid prescription and opioid use and could address related issues, such as depression, anxiety, and pain.
About the Program
The Hemodialysis Opioid Prescription Effort (HOPE) consortium will develop an intervention to address the problems of pain and opioid use in U.S. hemodialysis populations. The consortium will initiate multipronged pain treatment tailored to each patient, without opioids, and using buprenorphine and other novel agents to reduce dependence on opioids in affected patients.
Analyses will consider comorbid illnesses, such as diabetes and mental health disorders, and social determinants of health, such as socioeconomic status, social isolation, social support, residential factors, and perception of racial discrimination. The goal is to identify novel risk factors for pain and opioid use in this population.
End points will be chronic opioid prescription rates, prescription drug doses, pain control, patient satisfaction with care, perception of quality of life, hospitalization rates, and mortality rates. The consortium may use electronic health records to capture real-time risk factor and outcomes data by leveraging and expanding a pilot set of more than 200 standardized data elements that the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Chronic Kidney Disease eCare Plan Working Group identified and prioritized for comprehensive chronic kidney disease care.
The HOPE consortium comprises eight Clinical Centers (CCs) and a Scientific and Data Research Center (SDRC). The consortium will be funded for approximately $27.4 million through the Helping to End Addiction Long-termSM Initiative, or NIH HEAL InitiativeSM.
The governing body of the consortium will be the Steering Committee (SC), consisting of the principal investigator (PI) of the SDRC, the PIs of the CCs, the SC chair, and a community representative, to be appointed by NIDDK.
The final protocol for the intervention will be developed during the first funding year, and it will be approved by a data and safety monitoring board and NIDDK.
- Hennepin Healthcare Research Institute – Minnesota
- Massachusetts General Hospital – Massachusetts
- New York University – New York
- University of Illinois, Chicago – Illinois
- University of Pittsburgh – Pennsylvania
- University of Washington – Washington
- Vanderbilt University – Tennessee
- Yale University – Connecticut
Scientific and Data Research Center
- University of Pennsylvania – Pennsylvania