Cross-Sectional Study to Define and Validate "Doctor/Pharmacy Shopping" as Outcomes Suggestive of Abuse and/or Addiction
2 other identifiers
observational
164,923
0 countries
N/A
Brief Summary
The purpose of this study is to formulate definitions of doctor/pharmacy shopping and evaluate its association with abuse/addiction
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2015
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 5, 2015
CompletedFirst Submitted
Initial submission to the registry
January 20, 2016
CompletedFirst Posted
Study publicly available on registry
January 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 9, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 9, 2017
CompletedApril 15, 2020
April 1, 2020
2.5 years
January 20, 2016
April 14, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Numbers and proportions of patients with shopping behavior
Retrospective review over 18 month period starting with first dispensing in 2012
Sensitivity and predictive value of different levels of shopping behavior in relation with Algorithmically Identified Abuse and Addiction (AIAA)
Retrospective review over 18 month period starting with first dispensing in 2012
Study Arms (2)
Patients with Opioid dispensings
Patients receiving two or more opioid dispensings within 18 months
Patients with Diuretic dispensings (neg control)
Patients receiving two or more Diuretics dispensings within 18 months will serve as negative control
Interventions
Database review to evaluate of doctor/pharmacy shopping behaviors
Eligibility Criteria
Adult patients (18 years of age or older) with data in both IMS LRx and PharMetrics Plus, who also have a minimum of two dispensings for IR or ER/LA opioids or two or more diuretic dispensings. The first of these dispensings will have occurred in 2012 and an additional dispensing within 18 months after the first. Dispensings will be determined from the IMS LRx database.
You may qualify if:
- Age ≥ 18 years
- Minimum of two dispensings for IR or ER/LA opioids or two or more diuretic dispensings
You may not qualify if:
- N/A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Member Companies of the Opioid PMR Consortiumlead
- World Health Information Science Consultants, LLCcollaborator
- IMS Healthcollaborator
Related Publications (1)
Walker AM, Weatherby LB, Cepeda MS, Bradford DC. Information on doctor and pharmacy shopping for opioids adds little to the identification of presumptive opioid abuse disorders in health insurance claims data. Subst Abuse Rehabil. 2019 Aug 1;10:47-55. doi: 10.2147/SAR.S201725. eCollection 2019.
PMID: 31534380DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Soledad Cepeda, MD, PhD
Janssen Research & Development, LLC
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2016
First Posted
January 29, 2016
Study Start
February 5, 2015
Primary Completion
August 9, 2017
Study Completion
August 9, 2017
Last Updated
April 15, 2020
Record last verified: 2020-04