Acute Pain Pathways: protocol for a prospective cohort study
Authors: Jeffery Molly Moore , Ahadpour Mitra , Allen Summer , Araojo Richardae , Bellolio Fernanda , Chang Nancy , Ciaccio Laura , Emanuel Lindsay , Fillmore Jonathan , Gilbert Gregg H. , Koussis Patricia , Lee Christine , Lipkind Heather , Mallama Celeste , Meyer Tamra , Moncur Megan , Nuckols Teryl K. , Pacanowski Michael A. , Page David B. , Papadopoulos Elektra , Ritchie Jessica D. , Ross Joseph S. , Shah Nilay D. , Soukup Mat , St. Clair Christopher O. , Tamang Stephen , Torbati Sam S. , Wallace Douglas W. , Zhao Yueqin , Heckmann Rebekah 
Published: October 2021

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 multi-center prospective observational study will recruit 1,550 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-centered health data aggregating platform that consolidates data from study questionnaires, electronic health record data on health care 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-centered 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

Strengths and limitations of this study

This study addresses a key knowledge gap by recruiting a large and diverse group of patients with acute pain, following them for 6 months, and prospectively assessing their pain experience and acute pain treatment

Patients will be recruited from multiple treatment settings that are important in the treatment of acute pain, including emergency departments, primary care, dental settings, and surgical settings.

A patient-centered health data aggregating platform reduces the patient burden of participating in the trial by allowing participants to complete questionnaires when it is convenient and by automatically collecting data on physical activity, healthcare service use, and prescription fills

All participants will have been offered an opioid prescription, reducing the ability to compare outcomes across opioid and non-opioid pain medications

Despite a large sample size, there may be limited numbers of specific acute pain diagnoses with a sufficient sample to analyze and compare by condition/diagnosis