Acute pain pathways: protocol for a prospective cohort study

Abstract

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.

Keywords: accident & emergency medicine; oral & maxillofacial surgery; pain management; primary care.

Conflict of interest statement

Competing interests: In the past three years, Dr. Jeffery has received unrelated grant funding from the Agency for Healthcare Research and Quality, the National Institute on Drug Abuse, the National Heart, Lung, and Blood Institute, the American Cancer Society and the US Food and Drug Administration for the Yale-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI) (U01FD005938). Dr. Ross currently receives research support through Yale University from Johnson and Johnson to develop methods of clinical trial data sharing, from the Medical Device Innovation Consortium as part of the National Evaluation System for Health Technology (NEST), from the Food and Drug Administration for the Yale-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI) (U01FD005938), from the Agency for Healthcare Research and Quality (R01HS022882), from the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) (R01HS025164, R01HL144644), and from the Laura and John Arnold Foundation to establish the Good Pharma Scorecard at Bioethics International; in addition, Dr. Ross is an expert witness at the request of Relator's attorneys, the Greene Law Firm, in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen Inc. Ms. Ritchie currently receives research support through Yale University from Johnson & Johnson to develop methods of clinical trial data sharing, from the Medical Device Innovation Consortium as part of the National Evaluation System for Health Technology (NEST), and from the US Food and Drug Administration for the Yale-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI) (U01FD005938). Ms. Emanuel received research support from the Medical Device Innovation Consortium as part of the National Evaluation System for Health Technology (NEST) and from the US Food and Drug Administration for the Yale-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI) (U01FD005938). Dr. Gilbert currently receives research support from the National Institutes of Health (U19DE028717). Dr. Bellolio received funding from the National Center for Complementary and Integrative Health, the National Institute on Aging, and Diagnostic Robotics. Dr. Heckmann reported receiving salary support from CMS to develop, implement, and maintain hospital performance outcome measures that are publicly reported, in addition to receiving research support through Yale as part of a Centers for Disease Control and Prevention project designed to strengthen prescription drug overdose prevention efforts, from Connecticut Department of Public Health as part of a public health project designed to assess the impact of Good Samaritan Laws, and from the Community Health Network of Connecticut for her work as a medical consultant. Dr Lipkind serves on the Pfizer independent external data monitoring committee for the COVID-19 vaccine. Since leaving the Yale-New Haven Center for Outcomes Research and Evaluation, Ms. Ciaccio has been employed part-time at Hugo Health.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1

Study sites.