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

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

Study Overview

• Status: Completed
• Conditions: Opioid-Related Disorders; Drug Abuse; Opiate Addiction; Narcotic Abuse
• Intervention / Treatment: Other: Algorithm to identify patients experiencing opioid abuse/addiction

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.

• Study Type: Observational
• Enrollment (Actual): 1667

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with at least two years continuous enrollment in Group Health integrated group practice (IGP) receiving ER/LA opioid analgesics

Description

Inclusion Criteria:

1. Age ≥ 18 years
2. Receipt of at least a 60 day's supply of ER/LA opioid analgesics within a 90-day period (including transdermal or oral opioids but excluding buprenorpine)
3. Minimum of at least two years continuous enrollment in Group Health integrated group practice (IGP)

Exclusion Criteria:

1. Residence in a nursing home at any time during the study period
2. Enrollment in a hospice care program at any time during the study period

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Extended Release and/or Long-Acting Opioids	Other: Algorithm to identify patients experiencing opioid abuse/addiction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid abuse/addiction	This will be assessed from three data sources: a diagnostic algorithm that uses coded terms in claims data, Natural Language Processing assessment of text in electronic medical records, and medical chart review by clinicians trained in chart review	Retrospective review of data from 2006 to 2015, up to 9 years

Collaborators and Investigators

• Sponsor: Member Companies of the Opioid PMR Consortium
• Collaborators: Kaiser Permanente; World Health Information Science Consultants, LLC
• Investigators: Study Chair: Paul Coplan, MS, ScD, MBA, Purdue Pharma LP

Publications and helpful links

General Publications

• Carrell DS, Albertson-Junkans L, Ramaprasan A, Scull G, Mackwood M, Johnson E, Cronkite DJ, Baer A, Hansen K, Green CA, Hazlehurst BL, Janoff SL, Coplan PM, DeVeaugh-Geiss A, Grijalva CG, Liang C, Enger CL, Lange J, Shortreed SM, Von Korff M. Measuring problem prescription opioid use among patients receiving long-term opioid analgesic treatment: development and evaluation of an algorithm for use in EHR and claims data. J Drug Assess. 2020 Apr 28;9(1):97-105. doi: 10.1080/21556660.2020.1750419. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2015
• Primary Completion (Actual): May 17, 2017
• Study Completion (Actual): May 17, 2017

Study Registration Dates

• First Submitted: January 18, 2016
• First Submitted That Met QC Criteria: January 25, 2016
• First Posted (Estimate): January 28, 2016

Study Record Updates

• Last Update Posted (Actual): April 15, 2020
• Last Update Submitted That Met QC Criteria: April 14, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Compulsive Behavior; Impulsive Behavior; Substance-Related Disorders; Opioid-Related Disorders; Behavior, Addictive; Narcotic-Related Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: Observational Study 3033-7; 3033-7 (Other Identifier: Member Companies of the Opioid PMR Consortium)