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Clinical Trials/NCT03743493
NCT03743493
Completed
Not Applicable

PCORnet Opioid Surveillance Demonstration Project

Louisiana Public Health Institute24 sites in 1 country15,438,284 target enrollmentJuly 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Opioid Use
Sponsor
Louisiana Public Health Institute
Enrollment
15438284
Locations
24
Primary Endpoint
Occurrence of substance use disorder diagnoses among cohort groups stratified by demographic characteristics and geography
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2018
End Date
November 15, 2019
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Louisiana Public Health Institute
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

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

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

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

Counts used to derive rates

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

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

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

Counts used to derive rates

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

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

Opioid exposure (prescribing/dispensing) counts by Prevalance group

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

Counts used to derive rates

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

  • Characterization of opiate prescribing data for Guideline B patients(1/1/2010-12/31/2017)
  • Characterization of discharge disposition data for Guideline B patients(1/1/2010-12/31/2017)
  • Characterization of discharge status data for Guideline B patients(1/1/2010-12/31/2017)
  • Characterization of opiate dispensing data for Guideline B patients(1/1/2010-12/31/2017)
  • Characterization of urine drug screen data for Guideline B patients(1/1/2010-12/31/2017)
  • Characterization of provider data for Guideline B patients(1/1/2010-12/31/2017)
  • Characterization of facility data for Guideline B patients(1/1/2010-12/31/2017)
  • Characterization of prescribing provider data for Guideline B patients(1/1/2010-12/31/2017)
  • Characterization of admitting source data for Guideline B patients(1/1/2010-12/31/2017)
  • Characterization of smoking/tobacco data for Guideline B patients(1/1/2010-12/31/2017)
  • Characterization of prescription supply data for Guideline B patients(1/1/2010-12/31/2017)
  • Characterization of prescription quantity data for Guideline B patients(1/1/2010-12/31/2017)
  • Characterization of prescription refill data for Guideline B patients(1/1/2010-12/31/2017)
  • Characterization of urine drug screen results data for Guideline B patients(1/1/2010-12/31/2017)
  • Characterization of prescription type data for Guideline B patients(1/1/2010-12/31/2017)
  • Characterization of prescription dose data for Guideline B patients(1/1/2010-12/31/2017)
  • Distribution of prescription dose data for Guideline B patients(1/1/2010-12/31/2017)
  • Characterization of prescription dose frequency data for Guideline B patients(1/1/2010-12/31/2017)
  • Characterization of procedure data for Guideline B patients(1/1/2010-12/31/2017)
  • Characterization of vitals data for Guideline B patients(1/1/2010-12/31/2017)
  • Characterization of height data for Guideline B patients(1/1/2010-12/31/2017)
  • Characterization of systolic blood pressure data for Guideline B patients(1/1/2010-12/31/2017)
  • Characterization of language data for Guideline B patients(1/1/2010-12/31/2017)
  • Characterization of primary payer data for Guideline B patients(1/1/2010-12/31/2017)
  • Characterization of weight data for Guideline B patients(1/1/2010-12/31/2017)
  • Characterization of diastolic blood pressure data for Guideline B patients(1/1/2010-12/31/2017)
  • Characterization of secondary payer data for Guideline B patients(1/1/2010-12/31/2017)
  • Characterization of dispensed days supply data for Guideline B patients(1/1/2010-12/31/2017)

Study Sites (24)

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