Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-02-25 @ 4:36 PM
Study NCT ID:
NCT03743493
Status:
COMPLETED
Last Update Posted:
2020-11-12
First Post:
2018-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PCORnet Opioid Surveillance Study
Sponsor:
Louisiana Public Health Institute
Organization:
Study Overview
Official Title:
PCORnet Opioid Surveillance Demonstration Project
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overarching objective of this project is to demonstrate and assess the feasibility of using the Patient Centered Outcomes Research Network (PCORnet) Common Data Model for opioid surveillance to complement existing and support future initiatives. This project will characterize risk factors, processes, and outcomes related to opioid use, misuse, and abuse. It will quantify the utility of data stored in the PCORnet Common Data Model format stewarded by healthcare organizations participating in PCORnet.
Detailed Description:
This is a two phase retrospective study. The goal of Phase I is to assess the utility of PCORnet Common Data Mode (CDM) data to study risk factors, processes, and outcomes related to opioid use, misuse, and abuse. Based on the results of the Phase I feasibility examination, Phase II will be conducted and will analyze the relationships between patient- and provider-level risk factors and policies, and opioid-related outcomes over time and within geographic regions.
The study will leverage the existing data PCORnet data infrastructure and resources to achieve its objectives and answer its research questions. Standardized analysis programs will be distributed to participating sites within the PCORnet Distributed Research Network. Sites will return aggregate, descriptive counts and summary statistics from regression analyses. When data are unavailable or analysis is determined infeasible, results will be reported as such.
The Aims of Phase I are:
1. Generate counts and proportion of patients with exposure (or potential exposure) to opioids though prescription or dispensing records within a health system.
a. Compare results to CDC.
2. Characterize data elements in PCORnet data and assess suitability for opioid surveillance.
1. Identify the relevant data elements
2. Examine data completeness and validity
3. Identify data limitations and gaps that limit surveillance
The Aims of Phase II are:
1. Examine whether and to what extent patient-level risk factors, provider processes, and policies are associated with declines in outcomes of interest.
2. Examine whether and to what extent prescribing guidelines, related policies, processes, and/or care procedures are associated opioid-related outcomes.
The study will leverage the existing data PCORnet data infrastructure and resources to achieve its objectives and answer its research questions. Standardized analysis programs will be distributed to participating sites within the PCORnet Distributed Research Network. Sites will return aggregate, descriptive counts and summary statistics from regression analyses. When data are unavailable or analysis is determined infeasible, results will be reported as such.
The Aims of Phase I are:
1. Generate counts and proportion of patients with exposure (or potential exposure) to opioids though prescription or dispensing records within a health system.
a. Compare results to CDC.
2. Characterize data elements in PCORnet data and assess suitability for opioid surveillance.
1. Identify the relevant data elements
2. Examine data completeness and validity
3. Identify data limitations and gaps that limit surveillance
The Aims of Phase II are:
1. Examine whether and to what extent patient-level risk factors, provider processes, and policies are associated with declines in outcomes of interest.
2. Examine whether and to what extent prescribing guidelines, related policies, processes, and/or care procedures are associated opioid-related outcomes.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: