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Completed

NCT Number: NCT03743493

PCORnet Opioid Surveillance Study

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.

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Key information

Conditions

Opioid Use Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid Abuse Opioid-Related Disorders Substance-Related Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California - Irvine, Irvine, California, United States

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About this study

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:

  • 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.

  • Characterize data elements in PCORnet data and assess suitability for opioid surveillance.
  • Identify the relevant data elements
  • Examine data completeness and validity
  • Identify data limitations and gaps that limit surveillance

The Aims of Phase II are:

  • Examine whether and to what extent patient-level risk factors, provider processes, and policies are associated with declines in outcomes of interest.
  • Examine whether and to what extent prescribing guidelines, related policies, processes, and/or care procedures are associated opioid-related outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Opioid exposure (prescribing/dispensing) counts by Guideline A group

    Time frame: 1/1/2010-12/31/2017

    Counts used to derive rates

  2. Opioid exposure (prescribing/dispensing) counts by Guideline B group

    Time frame: 1/1/2010-12/31/2017

    Counts used to derive rates

  3. Opioid exposure (prescribing/dispensing) counts by Prevalance group

    Time frame: 1/1/2010-12/31/2017

    Counts used to derive rates

  4. Opioid exposure (prescribing/dispensing) counts stratified by demographic characteristics

    Time frame: 1/1/2010-12/31/2017

    Age group, sex, race and ethnicity; Counts used to derive rates

  5. Most common diagnoses among cohort groups stratified by demographic characteristics and geography

    Time frame: 1/1/2010-12/31/2017

    Frequencies of most common 1000 diagnosis codes stratified by age group, sex, race, ethnicity, and facility 3-digit zip code

  6. Most common procedures among cohort groups stratified by demographic characteristics and geography

    Time frame: 1/1/2010-12/31/2017

    Frequencies of most common 1000 procedure codes stratified by age group, sex, race, ethnicity, and facility 3-digit zip code

  7. Occurrence of mental health diagnoses among cohort groups stratified by demographic characteristics and geography

    Time frame: 1/1/2010-12/31/2017

    Frequencies of mental health diagnosis codes stratified by age group, sex, race, ethnicity, and facility 3-digit zip code

  8. Occurrence of opioid overdose diagnoses among cohort groups stratified by demographic characteristics and geography

    Time frame: 1/1/2010-12/31/2017

    Frequencies of opioid overdose stratified by age group, sex, race, ethnicity, and facility 3-digit zip code

  9. Occurrence of substance use disorder diagnoses among cohort groups stratified by demographic characteristics and geography

    Time frame: 1/1/2010-12/31/2017

    Frequencies of substance use disorder diagnoses stratified by age group, sex, race, ethnicity, and facility 3-digit zip code

  10. Opioid exposure (prescribing/dispensing) counts by cohort groups and provider

    Time frame: 1/1/2010-12/31/2017

    Stratified by age group, sex, race, ethnicity, and facility 3-digit zip code

  11. Most common diagnoses in patients with opioid-inclusive substance use disorder diagnoses

    Time frame: 1/1/2010-12/31/2017

    Frequencies of most common 1000 diagnosis codes overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code

  12. Most common procedures among patients with opioid-inclusive substance use disorder diagnoses

    Time frame: 1/1/2010-12/31/2017

    Frequencies of most common 1000 procedure codes overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code

  13. Occurrence of mental health diagnoses among patients with opioid-inclusive substance use disorder diagnoses

    Time frame: 1/1/2010-12/31/2017

    Frequencies of mental health diagnosis codes overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code

  14. Occurrence of urine drug screening in patients with opioid exposure (prescribing/dispensing)

    Time frame: 1/1/2010-12/31/2017

    Frequencies of urine drug screening procedures or lab codes overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code

  15. Frequency of HIV diagnoses in patients with opioid use disorder diagnosis

    Time frame: 1/1/2010-12/31/2017

    Counts overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code

  16. Frequency of Hepatitis B diagnoses in patients with opioid use disorder diagnosis

    Time frame: 1/1/2010-12/31/2017

    Counts overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code

  17. Frequency of Hepatitis C diagnoses in patients with opioid use disorder diagnosis

    Time frame: 1/1/2010-12/31/2017

    Counts overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code

  18. Frequency of opioid and benzodiazepine co-prescribing/dispensing

    Time frame: 1/1/2010-12/31/2017

    Counts overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code

  19. Frequency of Naloxone administration during an emergency department encounter among patients with an opioid overdose diagnosis

    Time frame: 1/1/2010-12/31/2017

    Counts overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code

  20. Frequency of Naloxone exposure (prescribing/dispensing) among patients with opioid exposure (prescribing/dispensing) by encounter setting

    Time frame: 1/1/2010-12/31/2017

    Counts overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code

  21. Frequency of Naloxone exposure (prescribing/dispensing) among patients with opioid-inclusive substance use disorder diagnosis by encounter setting

    Time frame: 1/1/2010-12/31/2017

    Counts overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code

  22. Frequency of buprenorphine exposure (prescribing/dispensing) among patients with opioid-inclusive substance use disorder diagnosis by encounter setting

    Time frame: 1/1/2010-12/31/2017

    Counts overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code

  23. Frequency of naltrexone exposure (prescribing/dispensing) among patients with opioid-inclusive substance use disorder diagnosis by encounter setting

    Time frame: 1/1/2010-12/31/2017

    Counts overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code

  24. Frequency of methadone exposure (prescribing/dispensing) among patients with opioid-inclusive substance use disorder diagnosis by encounter setting

    Time frame: 1/1/2010-12/31/2017

    Counts overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code

  25. Adjusted risk of overdose in patients with opioid exposure (prescribing/dispensing)

    Time frame: 1/1/2010-12/31/2017

    Patient level regression controlling for year, age, sex, race, ethnicity

  26. Adjusted risk of overdose in patients with opioid-inclusive substance use disorder diagnosis

    Time frame: 1/1/2010-12/31/2017

    Patient level regression controlling for year, age, sex, race, ethnicity

  27. Predictors of opioid exposure (prescribing/dispending) and rate of neonatal abstinence syndrome for women of child-bearing age

    Time frame: 1/1/2010-12/31/2017

    Regression controlling for year, age, race, ethnicity at patient and 3-digit zip code level

  28. Predictors of opioid-inclusive substance abuse disorder diagnosis and rate of neonatal abstinence syndrome for women of child-bearing age

    Time frame: 1/1/2010-12/31/2017

    Regression controlling for year, age, race, ethnicity at patient and 3-digit zip code level

  29. Adjusted risk of emergency department and inpatient utilization in patients with opioid exposure (prescribing/dispensing)

    Time frame: 1/1/2010-12/31/2017

    Regression controlling for year, age, race, ethnicity at patient and 3-digit zip code level

  30. Adjusted risk of emergency department and inpatient utilization in patients with opioid-inclusive substance abuse disorder diagnosis

    Time frame: 1/1/2010-12/31/2017

    Regression controlling for year, age, race, ethnicity at patient and 3-digit zip code level

  31. Adjusted risk of emergency department and inpatient utilization in patients with opioid overdose diagnosis

    Time frame: 1/1/2010-12/31/2017

    Regression controlling for year, age, race, ethnicity at patient and 3-digit zip code level

Secondary outcomes

  1. Characterization of opiate prescribing data for Guideline B patients

    Time frame: 1/1/2010-12/31/2017

    Count of patient encounters with opiate prescription record

  2. Characterization of opiate dispensing data for Guideline B patients

    Time frame: 1/1/2010-12/31/2017

    Count of patient encounters with opiate dispensing record

  3. Characterization of provider data for Guideline B patients

    Time frame: 1/1/2010-12/31/2017

    Count of providers from patient encounter records

  4. Characterization of prescribing provider data for Guideline B patients

    Time frame: 1/1/2010-12/31/2017

    Count of providers from patient opiate prescribing records

  5. Characterization of admitting source data for Guideline B patients

    Time frame: 1/1/2010-12/31/2017

    Count of patient encounters by admitting source type (frequencies)

  6. Characterization of discharge disposition data for Guideline B patients

    Time frame: 1/1/2010-12/31/2017

    Count of patient encounters by discharge disposition type (frequencies)

  7. Characterization of discharge status data for Guideline B patients

    Time frame: 1/1/2010-12/31/2017

    Count of patient encounters by discharge status (frequencies)

  8. Characterization of facility data for Guideline B patients

    Time frame: 1/1/2010-12/31/2017

    Count of patient encounters by facility location/type (frequencies)

  9. Characterization of urine drug screen data for Guideline B patients

    Time frame: 1/1/2010-12/31/2017

    Counts of patients with a urine drug screen lab result record

  10. Characterization of urine drug screen results data for Guideline B patients

    Time frame: 1/1/2010-12/31/2017

    Counts of patients with a urine drug screen lab by result (frequencies)

  11. Characterization of prescription type data for Guideline B patients

    Time frame: 1/1/2010-12/31/2017

    Counts of patient opiate prescriptions by RxNorm Term Types (frequencies)

  12. Characterization of prescription dose data for Guideline B patients

    Time frame: 1/1/2010-12/31/2017

    Counts of patient opiate prescriptions by dose ordered unit of measure (frequencies)

  13. Distribution of prescription dose data for Guideline B patients

    Time frame: 1/1/2010-12/31/2017

    Distribution of patient opiate prescriptions by dose ordered

  14. Characterization of prescription dose frequency data for Guideline B patients

    Time frame: 1/1/2010-12/31/2017

    Counts of patient opiate prescriptions by dose frequency (frequencies)

  15. Characterization of prescription supply data for Guideline B patients

    Time frame: 1/1/2010-12/31/2017

    Distribution of number of days supply of patient opiate prescriptions

  16. Characterization of prescription quantity data for Guideline B patients

    Time frame: 1/1/2010-12/31/2017

    Distribution of prescription quantity for patient opiate prescriptions

  17. Characterization of prescription refill data for Guideline B patients

    Time frame: 1/1/2010-12/31/2017

    Distribution of prescription refill numbers for patient opiate prescriptions

  18. Characterization of procedure data for Guideline B patients

    Time frame: 1/1/2010-12/31/2017

    Counts of patient procedures by coding type (frequencies)

  19. Characterization of vitals data for Guideline B patients

    Time frame: 1/1/2010-12/31/2017

    Counts of patient encounters with vitals records

  20. Characterization of smoking/tobacco data for Guideline B patients

    Time frame: 1/1/2010-12/31/2017

    Counts of patient vital records by smoking/tobacco type (frequencies)

  21. Characterization of language data for Guideline B patients

    Time frame: 1/1/2010-12/31/2017

    Percent completeness of patients with language preference in record

  22. Characterization of primary payer data for Guideline B patients

    Time frame: 1/1/2010-12/31/2017

    Percent completeness of patients with primary payer data in record

  23. Characterization of secondary payer data for Guideline B patients

    Time frame: 1/1/2010-12/31/2017

    Percent completeness of patients with secondary payer data in record

  24. Characterization of height data for Guideline B patients

    Time frame: 1/1/2010-12/31/2017

    Percent completeness of patients with height data in record

  25. Characterization of weight data for Guideline B patients

    Time frame: 1/1/2010-12/31/2017

    Percent completeness of patients with weight data in record

  26. Characterization of diastolic blood pressure data for Guideline B patients

    Time frame: 1/1/2010-12/31/2017

    Percent completeness of patients with diastolic data in record

  27. Characterization of systolic blood pressure data for Guideline B patients

    Time frame: 1/1/2010-12/31/2017

    Percent completeness of patients with systolic data in record

  28. Characterization of dispensed days supply data for Guideline B patients

    Time frame: 1/1/2010-12/31/2017

    Percent completeness of patients with days supply in the dispensing record

Sponsors and collaborators

Lead sponsor

Louisiana Public Health Institute

Other

Collaborators

  • ADVANCE Clinical Data Research Network
  • Centers for Disease Control and Prevention
  • Harvard Pilgrim Health Care
  • National Patient-Centered Clinical Research Network
  • New York City Clinical Data Research Network
  • PaTH: Towards a Learning Health System Clinical Data Research Network
  • Patient-Centered Outcomes Research Institute
  • Research Action for Health Network (REACHnet)
  • The Patient-Oriented Scalable National Network for Effectiveness Research

Registry information

Official study title

PCORnet Opioid Surveillance Demonstration Project

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 16, 2018
Registry last updated
Nov 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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