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Incidence and Predictors of Opioid Overdose and Death Among Long-Term Users of Opioid Analgesics

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ClinicalTrials.gov Identifier: NCT02662153
Recruitment Status : Active, not recruiting
First Posted : January 25, 2016
Last Update Posted : April 15, 2020
Sponsor:
Collaborators:
Kaiser Permanente
HealthCore, Inc.
Vanderbilt University
World Health Information Science Consultants, LLC
Optum, Inc.
Information provided by (Responsible Party):
Member Companies of the Opioid PMR Consortium

Tracking Information
First Submitted Date January 20, 2016
First Posted Date January 25, 2016
Last Update Posted Date April 15, 2020
Actual Study Start Date May 2, 2019
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 14, 2020)
Opioid overdose - fatal and nonfatal [ Time Frame: Retrospective review over period from October 1, 2006 to December 31, 2017 ]
Opioid overdose as identified in insurance claims, electronic medical records and National Death Index records.
Original Primary Outcome Measures
 (submitted: January 22, 2016)
Opioid overdose - fatal and nonfatal [ Time Frame: Retrospective review over period from January 1, 2006 to December 31, 2013 ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.

Condition Opioid Overdose
Intervention Other: Observation only
No intervention.
Study Groups/Cohorts
  • Long-term opioid-use cohort
    Persons who have received 70 or more days of Schedule II opioid dispensed in a 90-day period, after at least 183 days with no opioid dispensing.
    Intervention: Other: Observation only
  • IR/SA to ER/LA Switchers
    Persons who have switched to or added on an ER/LA product after stable use of an IR/SA opioid regimen.
    Intervention: Other: Observation only
  • IR/SA to IR/SA Switchers
    Persons who have switched to or added on a new IR/SA opioid after stable use of a different IR/SA opioid regimen.
    Intervention: Other: Observation only
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: April 14, 2020)
800000
Original Estimated Enrollment
 (submitted: January 22, 2016)
10000
Estimated Study Completion Date March 31, 2021
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
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

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02662153
Other Study ID Numbers Observational Study 3033-2
Study 3033-2 ( Other Identifier: Member Companies of the Opioid PMR Consortium )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Member Companies of the Opioid PMR Consortium
Study Sponsor Member Companies of the Opioid PMR Consortium
Collaborators
  • Kaiser Permanente
  • HealthCore, Inc.
  • Vanderbilt University
  • World Health Information Science Consultants, LLC
  • Optum, Inc.
Investigators
Study Chair: David Kern Janssen Research & Development, LLC
Principal Investigator: Alexander Walker WHISCON, Scientific Steering Committee
PRS Account Member Companies of the Opioid PMR Consortium
Verification Date April 2020