PCORnet Opioid Surveillance Study

PCORnet Opioid Surveillance Demonstration Project

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.

Study Overview

• Status: Completed
• Conditions: Opioid Use; Opioid Abuse

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.

• Study Type: Observational
• Enrollment (Actual): 15438284

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92697
      • University of California - Irvine
    • La Jolla, California, United States, 92093
      • University of California - San Diego
    • Los Angeles, California, United States, 90033
      • University of Southern California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
    • Los Angeles, California, United States, 90095
      • University of California - Los Angeles
    • San Diego, California, United States, 92093
      • Patient-Centered SCAlable National Network for Effectiveness Research
    • San Francisco, California, United States, 94143
      • University of California - San Francisco
    • San Mateo, California, United States, 94403
      • San Mateo Medical Center
  • Florida
    • Miami, Florida, United States, 33172
      • Health Choice Network
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • University Medical Center
    • New Orleans, Louisiana, United States, 70112
      • Research Action for Heath Network
  • Maryland
    • Baltimore, Maryland, United States, 21202
      • Johns Hopkins University
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Fenway Health
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medicine
    • New York, New York, United States, 10065
      • New York City Clinical Data Research Network
  • Oregon
    • Portland, Oregon, United States, 97201
      • ADVANCE Clinical Data Research Network
    • Portland, Oregon, United States, 97201
      • OCHIN, Inc
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State College of Medicine
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
    • Pittsburgh, Pennsylvania, United States, 15260
      • PaTH: Towards a Learning Health System Clinical Data Research Network
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Veteran's Affairs Health System
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor Scott & White Health
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with electronic health record data from participating clinical data research networks (CDRN) of PCORnet.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort
Prevalence numerator; An opioid prescribed or dispensed in the query period (1/1/2010-12/31/2017)
Prevalence denominator; Any diagnosis on record in the query period (1/1/2010-12/31/2017)
Guideline A numerator; 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; 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; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid exposure (prescribing/dispensing) counts by Guideline A group	Counts used to derive rates	1/1/2010-12/31/2017
Opioid exposure (prescribing/dispensing) counts by Guideline B group	Counts used to derive rates	1/1/2010-12/31/2017
Opioid exposure (prescribing/dispensing) counts by Prevalance group	Counts used to derive rates	1/1/2010-12/31/2017
Opioid exposure (prescribing/dispensing) counts stratified by demographic characteristics	Age group, sex, race and ethnicity; Counts used to derive rates	1/1/2010-12/31/2017
Most common diagnoses among cohort groups stratified by demographic characteristics and geography	Frequencies of most common 1000 diagnosis codes stratified by age group, sex, race, ethnicity, and facility 3-digit zip code	1/1/2010-12/31/2017
Most common procedures among cohort groups stratified by demographic characteristics and geography	Frequencies of most common 1000 procedure codes stratified by age group, sex, race, ethnicity, and facility 3-digit zip code	1/1/2010-12/31/2017
Occurrence of mental health diagnoses among cohort groups stratified by demographic characteristics and geography	Frequencies of mental health diagnosis codes stratified by age group, sex, race, ethnicity, and facility 3-digit zip code	1/1/2010-12/31/2017
Occurrence of opioid overdose diagnoses among cohort groups stratified by demographic characteristics and geography	Frequencies of opioid overdose stratified by age group, sex, race, ethnicity, and facility 3-digit zip code	1/1/2010-12/31/2017
Occurrence of substance use disorder diagnoses among cohort groups stratified by demographic characteristics and geography	Frequencies of substance use disorder diagnoses stratified by age group, sex, race, ethnicity, and facility 3-digit zip code	1/1/2010-12/31/2017
Opioid exposure (prescribing/dispensing) counts by cohort groups and provider	Stratified by age group, sex, race, ethnicity, and facility 3-digit zip code	1/1/2010-12/31/2017
Most common diagnoses in patients with opioid-inclusive substance use disorder diagnoses	Frequencies of most common 1000 diagnosis codes overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code	1/1/2010-12/31/2017
Most common procedures among patients with opioid-inclusive substance use disorder diagnoses	Frequencies of most common 1000 procedure codes overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code	1/1/2010-12/31/2017
Occurrence of mental health diagnoses among patients with opioid-inclusive substance use disorder diagnoses	Frequencies of mental health diagnosis codes overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code	1/1/2010-12/31/2017
Occurrence of urine drug screening in patients with opioid exposure (prescribing/dispensing)	Frequencies of urine drug screening procedures or lab codes overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code	1/1/2010-12/31/2017
Frequency of HIV diagnoses in patients with opioid use disorder diagnosis	Counts overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code	1/1/2010-12/31/2017
Frequency of Hepatitis B diagnoses in patients with opioid use disorder diagnosis	Counts overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code	1/1/2010-12/31/2017
Frequency of Hepatitis C diagnoses in patients with opioid use disorder diagnosis	Counts overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code	1/1/2010-12/31/2017
Frequency of opioid and benzodiazepine co-prescribing/dispensing	Counts overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code	1/1/2010-12/31/2017
Frequency of Naloxone administration during an emergency department encounter among patients with an opioid overdose diagnosis	Counts overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code	1/1/2010-12/31/2017
Frequency of Naloxone exposure (prescribing/dispensing) among patients with opioid exposure (prescribing/dispensing) by encounter setting	Counts overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code	1/1/2010-12/31/2017
Frequency of Naloxone exposure (prescribing/dispensing) among patients with opioid-inclusive substance use disorder diagnosis by encounter setting	Counts overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code	1/1/2010-12/31/2017
Frequency of buprenorphine exposure (prescribing/dispensing) among patients with opioid-inclusive substance use disorder diagnosis by encounter setting	Counts overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code	1/1/2010-12/31/2017
Frequency of naltrexone exposure (prescribing/dispensing) among patients with opioid-inclusive substance use disorder diagnosis by encounter setting	Counts overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code	1/1/2010-12/31/2017
Frequency of methadone exposure (prescribing/dispensing) among patients with opioid-inclusive substance use disorder diagnosis by encounter setting	Counts overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code	1/1/2010-12/31/2017
Adjusted risk of overdose in patients with opioid exposure (prescribing/dispensing)	Patient level regression controlling for year, age, sex, race, ethnicity	1/1/2010-12/31/2017
Adjusted risk of overdose in patients with opioid-inclusive substance use disorder diagnosis	Patient level regression controlling for year, age, sex, race, ethnicity	1/1/2010-12/31/2017
Predictors of opioid exposure (prescribing/dispending) and rate of neonatal abstinence syndrome for women of child-bearing age	Regression controlling for year, age, race, ethnicity at patient and 3-digit zip code level	1/1/2010-12/31/2017
Predictors of opioid-inclusive substance abuse disorder diagnosis and rate of neonatal abstinence syndrome for women of child-bearing age	Regression controlling for year, age, race, ethnicity at patient and 3-digit zip code level	1/1/2010-12/31/2017
Adjusted risk of emergency department and inpatient utilization in patients with opioid exposure (prescribing/dispensing)	Regression controlling for year, age, race, ethnicity at patient and 3-digit zip code level	1/1/2010-12/31/2017
Adjusted risk of emergency department and inpatient utilization in patients with opioid-inclusive substance abuse disorder diagnosis	Regression controlling for year, age, race, ethnicity at patient and 3-digit zip code level	1/1/2010-12/31/2017
Adjusted risk of emergency department and inpatient utilization in patients with opioid overdose diagnosis	Regression controlling for year, age, race, ethnicity at patient and 3-digit zip code level	1/1/2010-12/31/2017

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterization of opiate prescribing data for Guideline B patients	Count of patient encounters with opiate prescription record	1/1/2010-12/31/2017
Characterization of opiate dispensing data for Guideline B patients	Count of patient encounters with opiate dispensing record	1/1/2010-12/31/2017
Characterization of provider data for Guideline B patients	Count of providers from patient encounter records	1/1/2010-12/31/2017
Characterization of prescribing provider data for Guideline B patients	Count of providers from patient opiate prescribing records	1/1/2010-12/31/2017
Characterization of admitting source data for Guideline B patients	Count of patient encounters by admitting source type (frequencies)	1/1/2010-12/31/2017
Characterization of discharge disposition data for Guideline B patients	Count of patient encounters by discharge disposition type (frequencies)	1/1/2010-12/31/2017
Characterization of discharge status data for Guideline B patients	Count of patient encounters by discharge status (frequencies)	1/1/2010-12/31/2017
Characterization of facility data for Guideline B patients	Count of patient encounters by facility location/type (frequencies)	1/1/2010-12/31/2017
Characterization of urine drug screen data for Guideline B patients	Counts of patients with a urine drug screen lab result record	1/1/2010-12/31/2017
Characterization of urine drug screen results data for Guideline B patients	Counts of patients with a urine drug screen lab by result (frequencies)	1/1/2010-12/31/2017
Characterization of prescription type data for Guideline B patients	Counts of patient opiate prescriptions by RxNorm Term Types (frequencies)	1/1/2010-12/31/2017
Characterization of prescription dose data for Guideline B patients	Counts of patient opiate prescriptions by dose ordered unit of measure (frequencies)	1/1/2010-12/31/2017
Distribution of prescription dose data for Guideline B patients	Distribution of patient opiate prescriptions by dose ordered	1/1/2010-12/31/2017
Characterization of prescription dose frequency data for Guideline B patients	Counts of patient opiate prescriptions by dose frequency (frequencies)	1/1/2010-12/31/2017
Characterization of prescription supply data for Guideline B patients	Distribution of number of days supply of patient opiate prescriptions	1/1/2010-12/31/2017
Characterization of prescription quantity data for Guideline B patients	Distribution of prescription quantity for patient opiate prescriptions	1/1/2010-12/31/2017
Characterization of prescription refill data for Guideline B patients	Distribution of prescription refill numbers for patient opiate prescriptions	1/1/2010-12/31/2017
Characterization of procedure data for Guideline B patients	Counts of patient procedures by coding type (frequencies)	1/1/2010-12/31/2017
Characterization of vitals data for Guideline B patients	Counts of patient encounters with vitals records	1/1/2010-12/31/2017
Characterization of smoking/tobacco data for Guideline B patients	Counts of patient vital records by smoking/tobacco type (frequencies)	1/1/2010-12/31/2017
Characterization of language data for Guideline B patients	Percent completeness of patients with language preference in record	1/1/2010-12/31/2017
Characterization of primary payer data for Guideline B patients	Percent completeness of patients with primary payer data in record	1/1/2010-12/31/2017
Characterization of secondary payer data for Guideline B patients	Percent completeness of patients with secondary payer data in record	1/1/2010-12/31/2017
Characterization of height data for Guideline B patients	Percent completeness of patients with height data in record	1/1/2010-12/31/2017
Characterization of weight data for Guideline B patients	Percent completeness of patients with weight data in record	1/1/2010-12/31/2017
Characterization of diastolic blood pressure data for Guideline B patients	Percent completeness of patients with diastolic data in record	1/1/2010-12/31/2017
Characterization of systolic blood pressure data for Guideline B patients	Percent completeness of patients with systolic data in record	1/1/2010-12/31/2017
Characterization of dispensed days supply data for Guideline B patients	Percent completeness of patients with days supply in the dispensing record	1/1/2010-12/31/2017

Collaborators and Investigators

• Sponsor: Louisiana Public Health Institute
• Collaborators: Patient-Centered Outcomes Research Institute; Centers for Disease Control and Prevention; Harvard Pilgrim Health Care; National Patient-Centered Clinical Research Network; Research Action for Health Network (REACHnet); Patient-Centered SCAlable National Network for Effectiveness Research (pSCANNER); ADVANCE Clinical Data Research Network; New York City Clinical Data Research Network; PaTH: Towards a Learning Health System Clinical Data Research Network
• Investigators: Principal Investigator: Kristin A Lyman, JD, MHA, Louisiana Public Health Institute

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): November 15, 2019
• Study Completion (Actual): November 15, 2019

Study Registration Dates

• First Submitted: October 26, 2018
• First Submitted That Met QC Criteria: November 14, 2018
• First Posted (Actual): November 16, 2018

Study Record Updates

• Last Update Posted (Actual): November 12, 2020
• Last Update Submitted That Met QC Criteria: November 10, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: OpioidRCR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No