PCORnet Opioid Surveillance Study

Louisiana Public Health Institute

Status: Completed

Conditions: Opioid Abuse; Opioid Use

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03743493

OpioidRCR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15,438,284 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with an opioid exposure (prescription or dispense) or diagnosis from an encounter on record between 1/1/10-12/31/17.

Exclusion criteria

• Patients without an opioid exposure (prescription or dispense) or diagnosis from an encounter on record between 1/1/10-12/31/17.

Trial design

15,438,284 participants in 6 patient groups

Prevalence numerator

Description:

An opioid prescribed or dispensed in the query period (1/1/2010-12/31/2017)

Prevalence denominator

Description:

Any diagnosis on record in the query period (1/1/2010-12/31/2017)

Guideline A numerator

Description:

An opioid prescribed or dispensed in the query period (1/1/2010-12/31/2017) AND NO cancer diagnosis in the year prior to the index event

Guideline A denominator

Description:

Any diagnosis on record in the query period (1/1/2010-12/31/2017) AND NO cancer diagnosis in the year prior to the index event

Guideline B numerator

Description:

An opioid prescribed or dispensed in the query period (1/1/2010-12/31/2017) AND NO inpatient cancer diagnosis OR cancer procedure in the year prior to the index event

Guideline B denominator

Description:

Any diagnosis on record in the query period (1/1/2010-12/31/2017) AND NO in-patient cancer diagnosis OR cancer procedure in the year prior to the index event