Unintended Prolonged Opioid Use: A Case-Control Study.

Abstract

Background: Misuse of prescription opioids remains a public health problem. Appropriate short-term use of these medications in opioid-naïve patients is indicated in selected settings, but can result in unintended prolonged opioid use (UPOU), defined as the continuation of opioid therapy beyond the period by which acute pain would have been expected to resolve. Clinical strategies aimed at preventing UPOU are lacking due, in part, to the absence of information about how this poorly-understood clinical phenomenon actually develops.

Objective: In this research project, three Clinical and Translational Science Awards (CTSA) programs (Mayo Clinic, University of Michigan, and Yale University) leveraged the conceptual framework for UPOU to investigate how the patient characteristics, practice environment characteristics, and opioid prescriber characteristics facilitate or impede UPOU. All data management and analyses were conducted at a fourth CTSA program (University of Minnesota). This work was accomplished by pursuing three specific aims.

Methods: In aim 1, opioid-naïve adults receiving an initial opioid prescription were recruited for study participation. Opioid prescriptions were identified longitudinally and patterns of use were categorized as short-term, episodic or long-term utilizing established criteria. Using a prospective case-control design, patients progressing to UPOU were matched 1:1 with patients who did not develop UPOU and differences in patient characteristics were assessed. In aim 2, clinicians who prescribed opioids to patients in aim 1 were identified and recruited for prospective assessments. Institutional and individual practice environments were assessed using a validated self-report survey. In aim 3, structural equation modeling was utilized to evaluate data collected in aims 1 and 2 and identified interactions were further evaluated in a large national administrative claims database.

Results: Patient recruitment began August 1, 2019. However, due to the coronavirus disease of 2019 (COVID-19) pandemic, patient recruitment was slowed and intermittently interrupted over the ensuing 3 year period. As a result of regional variations in the impact of the COVID-19 pandemic on research activities, the majority of patient and clinician recruitment occurred at the Mayo Clinic site.

Conclusions: Following complete data analyses, it is anticipated that electronic health record systems will be leveraged to help clinicians identify at risk patients and to develop direct-to-patient educational materials to raise awareness of the risk factors for developing UPOU.

Clinicaltrial: Trial registration (clinicaltrials.gov): NCT04024397.