Study to Validate Coded Medical Terms Used to Identify Opioid-Related Overdose in Databases Used for PMR Study 1B

April 14, 2020 updated by: Member Companies of the Opioid PMR Consortium

Study to Validate Coded Medical Terminologies Used to Identify Opioid-Related Overdose in the Postmarketing Databases Employed in PMR Study 1B

The purpose of this study is to determine reliability of codes and data from electronic medical records to predict and measure overdose and death in patients prescribed opioid analgesics. The study will compare this electronic data to data manually obtained from medical charts.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

As part of a series of post-marketing requirement (PMR) studies for extended-release (ER) and long-acting (LA) opioid analgesics, the Food and Drug Administration (FDA) is requiring New Drug Application (NDA) holders of ER/LA opioids to conduct studies to estimate the incidence of misuse, abuse, addiction, overdose, and death among patients with chronic pain using long-term opioid therapy, and to validate the measures used to estimate the incidence of these adverse events.

The purpose of this study is to validate the measurement of opioid overdose events using diagnostic codes and data extracted from notes written in the electronic medical record (EMR), accompanied by diagnostic algorithms, to be used in a study of the incidence and predictors of opioid overdose and death (PMR Study 1B) among patients prescribed opioid analgesics. Diagnostic codes, accompanied by diagnostic algorithms, will be compared against manually abstracted medical chart reviews.

Code-based algorithms will be useful for identifying opioid overdoses in claims-based systems that include only coded data and will also find applicability in systems with EMRs. Code-based algorithms will be improved with text search of EMR clinical notations using Natural Language Processing (NLP) to identify overdose events not identified by diagnostic codes and to differentiate between intentional and unintentional overdoses. Yield from the resulting EMR-based algorithm will again be compared against manually abstracted medical chart reviews.

This EMR-based algorithm will be useful for identifying opioid overdoses in systems with EMRs, and for further differentiating between the causes of different types of overdoses. For example, overdose events can be due to misuse (e.g., therapeutic use not as indicated by a clinician), medication errors by patients, medical errors made by prescribers, abuse by patients, abuse by non-patients feigning to be patients in order to receive medications; and suicides. Overdose events therefore differ in intentionality, that is whether the person was attempting suicide or not. Unintentional overdoses can occur as a result of various causes, including misuse (therapeutic use but not consistent with clinician orders), abuse, adverse reactions to medications, anesthesia, and medication errors-both patient and provider-based. In addition, the distinction between unintentional and intentional overdoses can sometimes be unclear. This validation study will attempt to differentiate overdose by intentionality using both code-based algorithms and NLP-enhanced algorithms.

Currently, administrative databases use ICD-9 codes for nonfatal diagnoses and ICD-10 codes for fatal events. In October of 2015, ICD-10 codes are scheduled to replace ICD-9 codes for nonfatal diagnoses in administrative databases. This study will validate existing ICD-9 codes so that the study can meet the FDA-required timeline for a final report by November 2015.

This study will not evaluate misuse since this will be captured by instruments in a prospective study of patients with chronic pain (PMR Study 1A) using a combination of adapted validated instruments, and new instruments that will be evaluated in PMR Study 2. This study will not include a formal validation for opioid-related deaths, since processes for coding deaths vary from state to state, but will include some verification of opioid-related deaths relative to medical records for events with available state and national death data (there is a 12-month to 2-year lag in state death records).

Study Type

Observational

Enrollment (Actual)

2701

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Members of the KPNW integrated healthcare system located in Oregon and Washington prescribed opioid analgesics.

Description

Inclusion:

Members of the KPNW integrated healthcare system located in the states of Oregon and southwestern Washington, between August 2008 and December 2014

  • Approximately 1,200 events identified based on ICD diagnostic codes for opioid poisoning, overdose or opioid-related cause of death
  • A random sample of approximately 1,250 individuals at increased risk of opioid overdose identified based on ICD diagnoses for opioid-related adverse effects, pain, mental health, or substance abuse

Exclusion:

None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Opioid overdose and poisoning
Other: Algorithm to determine overdose from opioid abuse

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICD-9 codes for opioid overdoses
Time Frame: Retrospective review over four year period (January 2009 - December 2013)
  1. 965.0x Poisoning by opiates and related narcotics
  2. E850 Accidental poisoning by analgesics, antipyretics and anti-rheumatics
Retrospective review over four year period (January 2009 - December 2013)
Medical chart review by trained chart abstraction personnel and clinical diagnosticians.
Time Frame: Retrospective review over four year period (January 2009 - December 2013)
Retrospective review over four year period (January 2009 - December 2013)
Algorithms to improve the sensitivity and specificity of ICD-9 diagnosis codes for detecting opioid overdoses
Time Frame: Retrospective review over four year period (January 2009 - December 2013)
  1. Codes/procedures to rule out anesthetic-related overdose and poisonings, suicides, and serious adverse events
  2. Using coded medical records data, with or without Natural Language Processing (NLP) of clinical notations, to differentiate between suicides and unintentional overdoses.
  3. Using coded medical records data, with or without NLP of clinical notations, to identify abuse-related overdoses not coded as opioid poisonings but noted as such in patients' medical charts
  4. Identifying combinations of diagnostic, procedural, and prescription codes that, as a combination, are indicative of overdose (e.g., an ER visit at which injectable naloxone is administered followed within a few days by a prescription of buprenorphine-naloxone sublingual tablets [Suboxone]).
  5. Conduct medical chart review to verify probable cases detected by text search/NLP.
Retrospective review over four year period (January 2009 - December 2013)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 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

Other Study ID Numbers

  • Observational Study 3033-6
  • 3033-6 (Other Identifier: Member Companies of the Opioid PMR Consortium)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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