Study to Eval Relation Btw Doctor/Pharmacy Shopping & Outcomes of Misuse, Diversion, Abuse, Addiction by Med Rec Review

April 14, 2020 updated by: Member Companies of the Opioid PMR Consortium

Retrospective Cohort Study to Evaluate the Relation Between Doctor/Pharmacy Shopping and Outcomes Suggestive of Misuse, Diversion, Abuse and/or Addiction by Medical Record Review

To assess whether the percentage of patients with behaviors suggestive of misuse, diversion, abuse and/or addiction described in the medical record increases across pre-defined categories of increasing doctor/pharmacy shopping behavior.

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, diversion, abuse and/or addiction.

Study #2065-4 consists of three sub-studies, Study 4A, Study 4B, and Study 4C. In the current study (#2065-4 sub-study, Study 4C), the association of doctor/pharmacy shopping behavior with misuse, diversion, abuse and/or addiction will be assessed by reviewing medical charts in a sample of patients within specific categories of a priori defined doctor/pharmacy shopping. The four categories of doctor/pharmacy shopping behaviors identified and defined in Study 4A and will be applied to Study 4C. The medical chart is a rich source of information about the patient's medical conditions and behaviors suggestive of misuse and abuse. Medical record review for behaviors suggestive of misuse and abuse in patients with chronic pain discriminates between patients with and without opioid use disorders. Therefore, Study 4C was designed to utilize an insurance/health plan database (HealthCore Integrated Research Database [HIRD]) with access to medical records, to evaluate the association of a priori defined categories of doctor/pharmacy shopping and behaviors suggestive of misuse, diversion, abuse and/or addiction.

Study Type

Observational

Enrollment (Actual)

590

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

Probability Sample

Study Population

Patients identified from the HealthCore Integrated Research Database

Description

Inclusion Criteria:

  1. Patients 18 years or older on the date of first IR or ER/LA opioid dispensing in 2012
  2. Patients with at least two dispensings of any IR or ER/LA opioid. The first of these dispensings will have occurred in 2012 and an additional dispensing within 18 months after the first.
  3. Continuous, fully insured enrollment with medical and pharmacy eligibility in a health plan included in the HealthCore Integrated Research Database (HIRD) for at least six months prior to the start of the follow-up period.
  4. Patients with continuous enrollment during the follow-up period of 18 months

Exclusion Criteria:

  1. Patients who cannot be classified into one of the four a priori defined doctor/pharmacy shopping categories
  2. Patients for whom no medical records can be accessed
  3. Patients with a known history of abuse identified through the administrative claims data will be excluded because HealthCore is not permitted to request their medical records.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
No shopping behavior
Other: Medical Record Review
Medical Record Review of Behaviors Suggestive of Misuse, Diversion, Abuse and/or Addiction
Minimal shopping behavior
Other: Medical Record Review
Medical Record Review of Behaviors Suggestive of Misuse, Diversion, Abuse and/or Addiction
Marked shopping behavior
Other: Medical Record Review
Medical Record Review of Behaviors Suggestive of Misuse, Diversion, Abuse and/or Addiction
Extensive shopping behavior
Other: Medical Record Review
Medical Record Review of Behaviors Suggestive of Misuse, Diversion, Abuse and/or Addiction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The percentages of patients in each category having at least one and up to 34 (all) of the prespecified list of behaviors suggestive of misuse, diversion, abuse and/or addiction in their medical records
Time Frame: Retrospective review over 24 month period starting 6 months prior to first dispensing in 2012 and 18 month follow-up
Retrospective review over 24 month period starting 6 months prior to first dispensing in 2012 and 18 month follow-up
The correlation among the behaviors suggestive of misuse, diversion, abuse and/or addiction
Time Frame: Retrospective review over 24 month period starting 6 months prior to first dispensing in 2012 and 18 month follow-up
Retrospective review over 24 month period starting 6 months prior to first dispensing in 2012 and 18 month follow-up

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

HealthCore, Inc.

Investigators

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

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)

November 6, 2014

Primary Completion (Actual)

June 21, 2017

Study Completion (Actual)

June 21, 2017

Study Registration Dates

First Submitted

January 21, 2016

First Submitted That Met QC Criteria

January 27, 2016

First Posted (Estimate)

January 28, 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 3033-10
  • Study 3033-10 (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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