CERSI Collaborators: Nilay Shah, PhD (Mayo Clinic) (Site PI); Joseph Ross, MD, MHS (Yale) (Site PI); Molly Jeffery, PhD (Mayo Clinic) (Project PI)

CERSI Subcontractors: Monument Health (Stephen Tamang, MD- Site PI); University of Alabama at Birmingham (UAB, David Page, MD- Site PI), UAB Dentistry (Gregg Gilbert, DDS, MBA- Site PI), Cedars Sinai (Teryl Nuckols, MD- Site PI)

FDA Collaborators: Mitra Ahadpour, MD, DABAM; Richardae Araojo, PharmD, MS; Nancy Chang, MD; Patricia Koussis, RN; Christine Lee, PharmD, PhD; Celeste Mallama, PhD, MPH; Martin Mendoza, PhD; Tamra Meyer, PhD, MPH; Michael Pacanowski, PharmD, MPH; Elektra Papadopoulos, MD, MPH; Chandrahas Sahajwalla, PhD; Judy Staffa, PhD, RPh; Christopher StClair, PharmD; Mat Soukup, PhD; Yueqin Zhao, PhD; Megan Moncur, MS

Project Start Date: June 19, 2019

Regulatory Science Challenge

Many studies have described the differences reported by patients between the amount of opioid analgesic prescribed and the amount that they actually used to manage acute pain. However, these studies have generally assessed use after a limited number of surgical procedures, used small groups of patients at single institutions, and have not considered diverse populations that may have different demographics and social or cultural norms regarding opioid analgesic use. To better inform prescribing guidelines and public health measures, data are needed from diverse populations of patients on their use of opioid analgesics to manage acute pain, trajectories of pain experienced and response to opioids, and how patients dispose of these medications when no longer needed. Additionally, these data can help identify patient factors that predict variation in opioid analgesic use to incorporate into prescribing guidelines.

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 this task, FDA will support development of real-world data on patient-reported opioid analgesic use to manage acute pain to help develop evidence-based recommendations for opioid analgesic-prescribing for specific conditions or procedures commonly associated with acute pain.

Project Description and Goals

Using a novel health data-sharing platform (Hugo), the Yale-Mayo Clinic CERSI will enroll 1,550 patients who have been prescribed short-acting opioid analgesics after receiving care for new onset pain in the emergency department, primary care, or dental care offices at one of four diverse hospital systems. Patients will be followed for 180 days to collect information on pain control and opioid use through survey questionnaires sent via the Hugo app. 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 wearable 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.

Goal 1: To assess patients’ pain levels and function over time after episodes of acute pain for which opioid analgesics were prescribed and to track pain severity and persistence, as well as which prescribed and over-the-counter pain medications are used.

Goal 2: To examine associations between patient demographic, clinical, and emotional characteristics and pain and opioid use over time with a focus on inclusion of diverse patient populations.

Goal 3: To assess what patients did with their unused opioids.