ER/LA Opioid Surveillance for Emergency Department Visits and Hospitalizations for Overdose and Poisoning
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
1 other identifier
observational
183,452
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Primary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 8, 2016
CompletedFirst Posted
Study publicly available on registry
August 15, 2016
CompletedOctober 5, 2016
October 1, 2016
June 8, 2016
October 4, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Number of ED visits for opioid overdose/poisoning and mortality
Retrospective review over period from July 2010 through December 2014
Number of hospitalizations for opioid overdose/poisoning and mortality
Retrospective review over period from July 2010 through December 2014
Secondary Outcomes (1)
All-cause mortality
Retrospective review over period from July 2010 through December 2014
Study Arms (2)
All commercially insured patients in the HIRD
All Medicaid patients in a participating state Medicaid plan
Interventions
Eligibility Criteria
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.
You may qualify if:
- At least one dispensing of an ER/LA opioid after 01 July 2010
- 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
You may not qualify if:
- Missing or implausible values for age
- Missing or implausible values for gender
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ER/LA Opioid REMS Program Companies (RPC)lead
- HealthCore, Inc.collaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2016
First Posted
August 15, 2016
Primary Completion
October 1, 2015
Last Updated
October 5, 2016
Record last verified: 2016-10