Yale University and Mayo Clinic have been awarded a grant for up to $5.3 million over two years by the U.S. Food and Drug Administration (FDA) to study patients’ experiences with pain and use of opioids prescribed for acute pain. This project is part of the Center of Excellence in Regulatory Science and Innovation (CERSI), a joint effort between Yale, Mayo Clinic, and the FDA. The study will be conducted in collaboration with Regional Health of Rapid City, S.D., and University of Alabama at Birmingham (UAB).
Many studies have described the differences reported by patients between the amount of opioids prescribed and the amount that they actually used to manage acute pain. However, these studies have had several limitations, and have not considered diverse populations that may have different demographics and social or cultural norms regarding opioid use.
To better inform prescribing guidelines and public health measures, say experts, data are needed from diverse populations of patients about their use of opioids to manage acute pain; about pain experienced and response to opioids; and about how patients dispose of these medications after use.
“The Yale-Mayo Clinic CERSI is delighted to be working closely with the FDA, along with experts in the substance abuse clinical and research communities, to generate real-world evidence that can be used to better understand how patients use opioids for acute pain, and for how long opioids are needed, in order to inform guidelines and promote safer prescribing practices,” said Joseph Ross, M.D., professor of medicine and public health at Yale and principal investigator of the award.
Using a novel patient-centered health data sharing platform (Hugo), the Yale-Mayo Clinic CERSI will enroll 1,200 patients who have been prescribed short-acting opioids after receiving care for pain in the emergency department, primary care, or dental care offices at one of four diverse hospital systems, including Yale New Haven Health, Mayo Clinic, Regional Health, and UAB.
Patients will be followed for 180 days to collect information on pain control and opioid use through survey questionnaires sent via the Hugo platform. Additionally, patients will connect their electronic medical records and pharmacy data, when available, to the Hugo platform using their patient portal accounts. Patients will also use personal digital devices to gather additional insights into their activity and sleep patterns during the study period. At the end of follow-up, the CERSI will assess what patients did with their unused opioids.
“By recruiting patients who are being prescribed an opioid for acute pain, tracking their pain and its impact on their daily activities over time, along with how quickly or slowly the pain resolves, and what patients do when they run out of opioids, or don’t use them all, we will be able to better understand the safeguards that need to be put in place to protect the public, informing FDA’s actions,” said Nilay Shah, associate professor of health services research at Mayo Clinic and co-principal investigator of the award.
The congressional SUPPORT Act (Section 3002) has tasked FDA with developing evidence-based opioid analgesic prescribing guidelines for treating specific acute pain diagnoses where such guidelines do not exist.
“As part of the FDA’s ongoing efforts to advance our public health goals, confront the opioid crisis, and help support appropriate clinical practice, it’s important that objective, evidence-based prescribing guidelines are developed to help assure the proper use of opioid analgesics for the treatment of acute pain in appropriate patients,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “To aid in expanding the evidence base, this project is expected to generate data from diverse patient populations on their use of opioid analgesics to treat acute pain for multiple conditions and procedures and help identify patient factors that may predict variations in opioid analgesic use, which could help inform our work on opioid prescribing guidelines.”