ER/LA Opioid Surveillance for Emergency Department Visits and Hospitalizations for Overdose and Poisoning

October 4, 2016 updated by: ER/LA Opioid REMS Program Companies (RPC)

Extended Release (ER) / Long-acting (LA) Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) Assessment 5.1: Surveillance of Emergency Department Visits and Hospitalizations for Opioid Overdose and Poisoning Events

Study to evaluate the impact of the ER/LA opioid REMS program on the incidence of Emergency Department visits and hospitalizations for overdose/poisoning and death among patients prescribed ER/LA opioid analgesics.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

As part of the FDA-approved plan to evaluate the effects of the REMS program, the REMS Program Companies (RPC) are required to submit FDA assessment reports on a regular basis. The present study is one of several program evaluation components carried out in support Assessment 5: Surveillance monitoring for misuse, abuse, overdose, addiction, death and intervention taken. This study will evaluate the impact of the ER/LA opioid REMS program on the incidence of ED visits and hospitalizations for overdose/poisoning and death among patients prescribed ER/LA opioid analgesics.

Study Type

Observational

Enrollment (Actual)

183452

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients that receive at least one dispensing of an ER/LA opioid during at least one study REMS period with at least six months of prior continuous health plan eligibility in the main analyses. Additional analyses will consider patients enrolled in the HIRD or a participating Medicaid plan regardless of ER/LA opioid exposure.

Description

Inclusion Criteria:

  1. At least one dispensing of an ER/LA opioid after 01 July 2010
  2. At least six months of continuous health plan eligibility prior to the first recorded dispensing of an opioid that occurs during an included REMS period

Exclusion Criteria:

  1. Missing or implausible values for age
  2. Missing or implausible values for gender

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
All commercially insured patients in the HIRD
Other: Retrospective database review
All Medicaid patients in a participating state Medicaid plan
Other: Retrospective database review

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of ED visits for opioid overdose/poisoning and mortality
Time Frame: Retrospective review over period from July 2010 through December 2014
Retrospective review over period from July 2010 through December 2014
Number of hospitalizations for opioid overdose/poisoning and mortality
Time Frame: Retrospective review over period from July 2010 through December 2014
Retrospective review over period from July 2010 through December 2014

Secondary Outcome Measures

Outcome Measure
Time Frame
All-cause mortality
Time Frame: Retrospective review over period from July 2010 through December 2014
Retrospective review over period from July 2010 through December 2014

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ER/LA Opioid REMS Program Companies (RPC)

Collaborators

HealthCore, Inc.

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

Primary Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

June 8, 2016

First Submitted That Met QC Criteria

August 10, 2016

First Posted (Estimate)

August 15, 2016

Study Record Updates

Last Update Posted (Estimate)

October 5, 2016

Last Update Submitted That Met QC Criteria

October 4, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Assessment 5.1

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.

Clinical Trials on Drug Abuse

Clinical Trials on Retrospective database review

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe