Cross-Sectional Study to Define and Validate "Doctor/Pharmacy Shopping" as Outcomes Suggestive of Abuse and/or Addiction

April 14, 2020 updated by: Member Companies of the Opioid PMR Consortium
The purpose of this study is to formulate definitions of doctor/pharmacy shopping and evaluate its association with abuse/addiction

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Based on a review of the literature, the Food and Drug Administration (FDA) concluded that more data are needed regarding the serious risks of misuse, abuse, addiction, overdose, and death associated with the long-term use of extended release/long acting (ER/LA) opioid analgesics. Thus, the FDA is requiring that ER/LA opioid analgesic drug sponsors conduct post-marketing studies to assess these risks. The four observational post-marketing requirement (PMR) studies are labeled Study #2065-1, Study #2065-2, Study #2065-3, and Study #2065-4.

The objective of PMR Study #2065-4 is to define and validate "doctor/pharmacy shopping" as outcomes suggestive of misuse, abuse and/or addiction.

Study #2065-4 consists of three sub-studies, Study 4A, Study 4B, and Study 4C. In the current study (#2065 sub-study, Study 4A), the IMS® LRx database, a longitudinal pharmacy database that captures both third-party and self-pay transactions, will be linked to the PharMetrics Plus™ database, which contains provider, facility and pharmacy claims. From these databases, patients with shopping behavior will be identified and evaluated against an algorithm for abuse/addiction that will be developed and validated in PMR Study #2065-3B. Study #2065-3B will review the literature for health information suggestive of abuse/addiction in medical charts and medical claims. Then, through iterative processes that involve experts reviewing claims profiles and medical charts, text searches of medical records using natural language processing and supervised machine learning will identify and create a compilation of codes and health information with the best specificity and sensitivity to identify patients with opioid abuse/addiction. The compilation of codes and health information will be used to develop the algorithm that Study 4A will apply to define abuse/addiction. Restricting the validation of shopping behavior to only patients with diagnoses related to abuse would ignore the population with undiagnosed abuse. By supplementing ICD-9 codes with other information available on claims (e.g., addiction treatments, emergency visits) to define abuse/addiction, the measurement bias will be decreased and the estimates of the association of shopping behavior with abuse/addiction will be more valid. Categories of doctor shopping will be derived from the population distributions of the multiple variables analyzed for opioid users. The 4 categories will range from no shopping behavior (lowest level) to extensive shopping behavior (most extreme). The specifics of how the categories will be defined will be driven by the data.

Study Type

Observational

Enrollment (Actual)

164923

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Minimum of two dispensings for IR or ER/LA opioids or two or more diuretic dispensings

Exclusion Criteria:

N/A

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with Opioid dispensings
Patients receiving two or more opioid dispensings within 18 months
Other: DB review for Doctor/Pharmacy Shopping Behavior
Database review to evaluate of doctor/pharmacy shopping behaviors
Patients with Diuretic dispensings (neg control)
Patients receiving two or more Diuretics dispensings within 18 months will serve as negative control
Other: DB review for Doctor/Pharmacy Shopping Behavior
Database review to evaluate of doctor/pharmacy shopping behaviors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Numbers and proportions of patients with shopping behavior
Time Frame: Retrospective review over 18 month period starting with first dispensing in 2012
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)
Time Frame: Retrospective review over 18 month period starting with first dispensing in 2012
Retrospective review over 18 month period starting with first dispensing in 2012

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

World Health Information Science Consultants, LLC
IMS Health

Investigators

  • Study Chair: Soledad Cepeda, MD, PhD, Janssen Research and Development

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)

February 5, 2015

Primary Completion (Actual)

August 9, 2017

Study Completion (Actual)

August 9, 2017

Study Registration Dates

First Submitted

January 20, 2016

First Submitted That Met QC Criteria

January 26, 2016

First Posted (Estimate)

January 29, 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 3033-8
  • 3033-8 (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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