Clinical Trials Directory

Trials / Completed

CompletedNCT02667262

An Observational Study to Develop Algorithms for Identifying Opioid Abuse and Addiction Based on Admin Claims Data

An Observational Study to Develop Computable Algorithms for Identifying Opioid Abuse and Addiction Based on Administrative Claims Data

Status
Completed
Phase
Study type
Observational
Enrollment
1,667 (actual)
Sponsor
Member Companies of the Opioid PMR Consortium · Industry
Sex
All
Age
18 Years
Healthy volunteers

Summary

The purpose of this study is to develop and validate a classification model based entirely on medical claims data that can be used to identify patients experiencing prescription opioid abuse/addiction among patients receiving extended-release (ER) and/or long-acting (LA) opioids

Detailed description

The most widely available information about patient care and conditions is that contained in medical claims data. If such data can be used to develop a model for identifying patients experiencing prescription opioid abuse/addiction it could be widely applied to patient populations throughout the United States. A study recently conducted at Group Health comparing International Classification of Disease, Ninth edition (ICD-9) coding for opioid abuse/addiction to textual mentions in clinical notes describing abuse/addiction found that ICD-9 codes were 64% sensitive and 96% specific in their ability to identify patients experiencing opioid abuse/addiction (compared to evidence from clinical notes). This Group Health study considered codes for abuse (305.x) and addiction (304.x) equivalent because clinicians' usage of these codes did not differentiate well between abuse and addiction. Needed are methods that can accurately identify patients experiencing opioid abuse/addiction based on widely available claims data. This study will not evaluate opioid misuse because this will be captured by instruments in a prospective study of pain patients (Study 1A) using a combination of adapted validated instruments, and other new instruments that will be evaluated in post-marketing requirement (PMR) Study 2, plus medical record review to supplement questionnaire-based measurement of misuse, abuse and addiction with aberrant behaviors and physician text entries in the medical records.

Conditions

Interventions

TypeNameDescription
OTHERAlgorithm to identify patients experiencing opioid abuse/addiction

Timeline

Start date
2015-05-20
Primary completion
2017-05-17
Completion
2017-05-17
First posted
2016-01-28
Last updated
2020-04-15

Source: ClinicalTrials.gov record NCT02667262. Inclusion in this directory is not an endorsement.