Summary

at San Francisco, California and other locations
study started
estimated completion

Description

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.

Official Title

PCORnet Opioid Surveillance Demonstration Project

Details

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.
  2. Compare results to CDC.
  3. Characterize data elements in PCORnet data and assess suitability for opioid surveillance.
  4. Identify the relevant data elements
  5. Examine data completeness and validity
  6. 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.

Keywords

Opioid UseOpioid AbuseOpioid-Related DisordersAnalgesics, OpioidPrevalence numeratorPrevalence denominatorGuideline A numeratorGuideline A denominatorGuideline B numeratorGuideline B denominator

Eligibility

You can join if…

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

You CAN'T join if...

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

Locations

  • University of California - San Francisco
    San FranciscoCalifornia94143United States
  • San Mateo Medical Center
    San MateoCalifornia94403United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Louisiana Public Health Institute
ID
NCT03743493
Study Type
Observational
Last Updated