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

NCT ID: NCT02667262

Last Updated: 2020-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1667 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-20

Study Completion Date

2017-05-17

Brief Summary

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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

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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

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Opioid-Related Disorders Opiate Addiction Narcotic Abuse Drug Abuse

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Extended Release and/or Long-Acting Opioids

Algorithm to identify patients experiencing opioid abuse/addiction

Intervention Type OTHER

Interventions

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Algorithm to identify patients experiencing opioid abuse/addiction

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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World Health Information Science Consultants, LLC

OTHER

Sponsor Role collaborator

Kaiser Permanente

OTHER

Sponsor Role collaborator

Member Companies of the Opioid PMR Consortium

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul Coplan, MS, ScD, MBA

Role: STUDY_CHAIR

Purdue Pharma LP

References

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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.

Reference Type DERIVED
PMID: 32489718 (View on PubMed)

Other Identifiers

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3033-7

Identifier Type: OTHER

Identifier Source: secondary_id

Observational Study 3033-7

Identifier Type: -

Identifier Source: org_study_id

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