Acute pain pathways: protocol for a prospective cohort study
Christine Lee,
Joseph S Ross,
Molly Moore Jeffery,
Nilay D Shah,
David B Page,
Nancy Chang,
Fernanda Bellolio,
Sam Torbati,
Jessica D Ritchie,
Gregg H Gilbert,
Lindsay Emanuel,
Mitra Ahadpour,
Summer Allen,
Richardae Araojo,
Laura Ciaccio,
Jonathan Fillmore,
Patricia Koussis,
Heather Lipkind,
Celeste Mallama,
Tamra Meyer,
Megan Moncur,
Teryl Nuckols,
Michael A Pacanowski,
Elektra Papadopoulos,
Mat Soukup,
Christopher O St. Clair,
Stephen Tamang,
Douglas W Wallace,
Yueqin Zhao,
Rebekah Heckmann
Affiliations
Christine Lee
Office of the Commissioner, Office of Minority Health and Health Equity, US Food and Drug Administration, Silver Spring, Maryland, USA
Joseph S Ross
Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut, USA
Molly Moore Jeffery
Division of Health Care Delivery Research and Department of Emergency Medicine, Mayo Clinic, Rochester, Minnesota, USA
Nilay D Shah
Health Sciences Research, Mayo Clinic, Rochester, Minnesota, USA
David B Page
Earle A Chiles Research Institute, Portland, Oregon, USA
Nancy Chang
Center for Drug Evaluation and Research, Office of Translational Sciences, US Food and Drug Administration, Silver Spring, Maryland, USA
Fernanda Bellolio
Emergency Medicine and Health Care Delivery Research, Mayo Clinic, Rochester, Minnesota, USA
Sam Torbati
Department of Emergency Medicine, Cedars-Sinai Medical Center, Los Angeles, California, USA
Jessica D Ritchie
Yale-New Haven Center for Outcomes Research and Evaluation (CORE), Yale School of Medicine, New Haven, Connecticut, USA
Gregg H Gilbert
Department of Clinical and Community Sciences, School of Dentistry, The University of Alabama at Birmingham School of Dentistry, Birmingham, Alabama, USA
Lindsay Emanuel
Division of Health Care Delivery Research, Kern Center for the Science of Health Care Delivery, Mayo Clinic Rochester, Rochester, Minnesota, USA
Mitra Ahadpour
Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology, US Food and Drug Administration, Silver Spring, Maryland, USA
Summer Allen
Knowledge and Evaluation Research Unit; Department of Family Medicine, Mayo Clinic Rochester, Rochester, Minnesota, USA
Richardae Araojo
Office of the Commissioner, Office of Minority Health and Health Equity, US Food and Drug Administration, Silver Spring, Maryland, USA
Laura Ciaccio
1 Division of Population Health and Genomics, University of Dundee School of Medicine, Dundee, UK
Jonathan Fillmore
Department of Surgery, Mayo Clinic Division of Oral and Maxillofacial Surgery, Rochester, Minnesota, USA
Patricia Koussis
Center for Drug Evaluation and Research, Office of Translational Sciences, US Food and Drug Administration, Silver Spring, Maryland, USA
Heather Lipkind
Department of Obstetrics, Gynecology, & Reproductive Sciences, Yale School of Medicine, New Haven, Connecticut, USA
Celeste Mallama
Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology, US Food and Drug Administration, Silver Spring, Maryland, USA
Tamra Meyer
Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology, US Food and Drug Administration, Silver Spring, Maryland, USA
Megan Moncur
Center for Drug Evaluation and Research, Office of New Drugs, US Food and Drug Administration, Silver Spring, Maryland, USA
Teryl Nuckols
Division of General Internal Medicine, Cedars-Sinai Medical Center, Los Angeles, California, USA
Michael A Pacanowski
Center for Drug Evaluation and Research, Office of Translational Sciences, US Food and Drug Administration, Silver Spring, Maryland, USA
Elektra Papadopoulos
Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA
Mat Soukup
Center for Drug Evaluation and Research, Office of Translational Sciences, US Food and Drug Administration, Silver Spring, Maryland, USA
Christopher O St. Clair
Center for Drug Evaluation and Research, Office of New Drugs, US Food and Drug Administration, Silver Spring, Maryland, USA
Stephen Tamang
Department of Family Medicine, Monument Health, Rapid City, South Dakota, USA
Douglas W Wallace
Department of Emergency Medicine, Department of Medicine, Division of Pulmonary, Allergy & Critical Care Medicine, The University of Alabama, Birmingham, Alabama, USA
Yueqin Zhao
Center for Drug Evaluation and Research, Office of Translational Sciences, US Food and Drug Administration, Silver Spring, Maryland, USA
Rebekah Heckmann
Yale New Haven Health System, New Haven, Connecticut, USA
Introduction Opioid analgesics are often used to treat moderate-to-severe acute non-cancer pain; however, there is little high-quality evidence to guide clinician prescribing. An essential element to developing evidence-based guidelines is a better understanding of pain management and pain control among individuals experiencing acute pain for various common diagnoses.Methods and analysis This multicentre prospective observational study will recruit 1550 opioid-naïve participants with acute pain seen in diverse clinical settings including primary/urgent care, emergency departments and dental clinics. Participants will be followed for 6 months with the aid of a patient-centred health data aggregating platform that consolidates data from study questionnaires, electronic health record data on healthcare services received, prescription fill data from pharmacies, and activity and sleep data from a Fitbit activity tracker. Participants will be enrolled to represent diverse races and ethnicities and pain conditions, as well as geographical diversity. Data analysis will focus on assessing patients’ patterns of pain and opioid analgesic use, along with other pain treatments; associations between patient and condition characteristics and patient-centred outcomes including resolution of pain, satisfaction with care and long-term use of opioid analgesics; and descriptive analyses of patient management of leftover opioids.Ethics and dissemination This study has received approval from IRBs at each site. Results will be made available to participants, funders, the research community and the public.Trial registration number NCT04509115.
