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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02667262
Recruitment Status : Unknown
Verified April 2017 by Member Companies of the Opioid PMR Consortium.
Recruitment status was:  Active, not recruiting
First Posted : January 28, 2016
Last Update Posted : April 28, 2017
Sponsor:
Collaborators:
World Health Information Science Consultants, LLC
Kaiser Permanente
Information provided by (Responsible Party):
Member Companies of the Opioid PMR Consortium

Brief 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

Condition or disease Intervention/treatment
Opioid-Related Disorders Opiate Addiction Narcotic Abuse Drug Abuse 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.

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Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: An Observational Study to Develop Computable Algorithms for Identifying Opioid Abuse and Addiction Based on Administrative Claims Data
Estimated Primary Completion Date : September 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Opioid abuse/addiction [ Time Frame: Retrospective review of data from 2006 to 2015, up to 9 years ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02667262


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

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Responsible Party: Member Companies of the Opioid PMR Consortium
ClinicalTrials.gov Identifier: NCT02667262    
Other Study ID Numbers: Observational Study 3B
2065-3B ( Other Identifier: Member Companies of the Opioid PMR Consortium )
First Posted: January 28, 2016    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Substance-Related Disorders
Opioid-Related Disorders
Behavior, Addictive
Compulsive Behavior
Impulsive Behavior
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents