Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02866266
Recruitment Status : Unknown
Verified October 2016 by ER/LA Opioid REMS Program Companies (RPC).
Recruitment status was:  Active, not recruiting
First Posted : August 15, 2016
Last Update Posted : October 5, 2016
Sponsor:
Collaborator:
HealthCore, Inc.
Information provided by (Responsible Party):
ER/LA Opioid REMS Program Companies (RPC)

Brief Summary:
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.

Condition or disease Intervention/treatment
Opioid-related Disorders Opioid Addiction Narcotic Abuse Drug Abuse Other: Retrospective database review

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 183452 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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
Actual Primary Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Poisoning

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



Primary Outcome Measures :
  1. Number of ED visits for opioid overdose/poisoning and mortality [ Time Frame: Retrospective review over period from July 2010 through December 2014 ]
  2. Number of hospitalizations for opioid overdose/poisoning and mortality [ Time Frame: Retrospective review over period from July 2010 through December 2014 ]

Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: Retrospective review over period from July 2010 through December 2014 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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.
Criteria

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

Layout table for additonal information
Responsible Party: ER/LA Opioid REMS Program Companies (RPC)
ClinicalTrials.gov Identifier: NCT02866266     History of Changes
Other Study ID Numbers: Assessment 5.1
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: October 5, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Layout table for MeSH terms
Emergencies
Substance-Related Disorders
Opioid-Related Disorders
Poisoning
Disease Attributes
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders