NCT02667262

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,667

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 28, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2017

Completed
Last Updated

April 15, 2020

Status Verified

April 1, 2020

Enrollment Period

2 years

First QC Date

January 18, 2016

Last Update Submit

April 14, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Opioid abuse/addiction

    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

    Retrospective review of data from 2006 to 2015, up to 9 years

Study Arms (1)

Extended Release and/or Long-Acting Opioids

Other: Algorithm to identify patients experiencing opioid abuse/addiction

Interventions

Extended Release and/or Long-Acting Opioids

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with at least two years continuous enrollment in Group Health integrated group practice (IGP) receiving ER/LA opioid analgesics

You may qualify if:

  • Age ≥ 18 years
  • 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)
  • Minimum of at least two years continuous enrollment in Group Health integrated group practice (IGP)

You may not qualify if:

  • Residence in a nursing home at any time during the study period
  • Enrollment in a hospice care program at any time during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Opioid-Related DisordersNarcotic-Related DisordersSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Paul Coplan, MS, ScD, MBA

    Purdue Pharma LP

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2016

First Posted

January 28, 2016

Study Start

May 20, 2015

Primary Completion

May 17, 2017

Study Completion

May 17, 2017

Last Updated

April 15, 2020

Record last verified: 2020-04