Clinical trial NCT02662153: Incidence and Predictors of Opioid Overdose and Death Among Long-Term Users of Opioid Analgesics
Official title: Incidence and Predictors of Opioid Overdose and Death Among Users of Opioid Analgesics as Measured by Diagnoses and Death Records - a Retrospective Database Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid Overdose
Lead sponsor: Member Companies of the Opioid PMR Consortium
Sponsor class: INDUSTRY
Collaborators: name: Kaiser Permanente
name: HealthCore, Inc.
name: Vanderbilt University
name: World Health Information Science Consultants, LLC
name: Optum, Inc.
First posted: 2016-01-25
Enrollment: 808455
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The source populations will be those members of the selected health plans and insurance programs identified for which full demographic, provider, facility and pharmacy data are available, and in which protected health information (PHI) can be linked to death certificate information.

The four large healthcare systems that have established electronic databases for studying coded terminology outcomes selected for this study are: Kaiser Permanente Northwest; HealthCore, Inc. with access to commercial insurance data; Optum with access to commercial insurance data; and Vanderbilt University with access to Medicaid data for the State of Tennessee.

Brief summary: Retrospective study to assess incidence and predictors of opioid abuse overdose and death associated with opioid overdose among patients prescribed opioid products in long-term use.

Detailed description: The purpose of this study is to quantify risk, and predictors of risks for opioid overdose and for death associated with opioid overdose in persons who are or have been long-term recipients of prescriptions for Schedule II opioids. The study uses coded terms in large heath databases maintained by healthcare providers and health insurers, supplemented by overdose deaths identified from the National Death Index. The terms for overdose are combined following validated rules as developed in companion studies. The study is being conducted in parallel with a prospective questionnaire-based cohort study of the same risks.

Eligibility criteria: Inclusion Criteria:

* In the primary analysis, persons known to have had at least six months of no opioid dispensing who subsequently receive at least 70 days of Schedule II opioid dispensed within a 90-day period and who have not previously experienced an opioid overdose.
* In a secondary analysis, persons who have been long-term users of IR/SA opioids and who switch to a different Schedule II IR/SA opioid product or to an ER/LA opioid
* In another secondary analysis, persons with at least six months of presence in the health insurance data who have not received opioids in the preceding 30 days, and have not previously experienced an opioid overdose

Exclusion Criteria:

• Experience of opioid overdose in the six months preceding inclusion

Primary outcomes:
measure: Opioid overdose - fatal and nonfatal
timeFrame: Retrospective review over period from October 1, 2006 to December 31, 2017
Secondary outcomes:
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: HealthCore Inc
state: Delaware
city: Boston
country: United States
facility: Optum
state: Massachusetts
city: Portland
country: United States
facility: Kaiser Permanente Northwest
state: Oregon
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Epi Ideas LLC
name: Kenneth R Petronis
role: STUDY_CHAIR
affiliation: Optum, Inc.
name: John D Seeger
role: PRINCIPAL_INVESTIGATOR
References: